A Phase 1 interventional study of PF-07304814 and Placebo in Viral Disease, sponsored by Pfizer. Completed at 13 sites in 4 countries. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
It is Phase 1b, 2-part, double-blind, placebo-controlled study to evaluate safety, tolerability, and pharmacokinetics of PF-07304814, in patients hospitalized with SARS-CoV-2 virus infection.
It is a 2-part study in hospitalized COVID-19 patients.
Part 1 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF-07304814 given as 24-hour IV infusion.
2 planned and 3 optional cohorts with 8 participants each are planned.
Part 2 is to evaluate safety, tolerability, PK and markers of clinical activity of escalating doses of PF- 07304814 given as 120-hour infusion.
2 planned and 2 optional cohorts with 8 participants each are planned
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 26 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Male or female participants between the ages of 18 and 79 years.
Evidence of critical illness, defined by at least one of the following: Respiratory failure, Multi-organ dysfunction/failure, Cardiac failure or septic shock
3.Participants with a known medical history of recent acute or chronic liver disease (other than NASH), chronic or active hepatitis B or C infection, or primary biliary cirrhosis.
4.Participants with a known medical history of ischemic heart disease, heart failure, dysrhythmia or other pre-existing cardiac condition.
6.Participants with a known medical history of recurrent seizures. 7. Participants with history of venous thromboembolic event, including deep venous thrombosis or pulmonary embolism 8.Confirmed concurrent active systemic infection other than COVID-19. 9.Current diagnosis of cancer, unless in remission and untreated. 10.Other medical or psychiatric condition including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation 11.Females who are pregnant or breastfeeding.
Part 1: Cohort 1-5 Part 2: Cohort 6-9
Drug: PF-07304814
Part 1: Cohort 1-5 Part 2: Cohort 6-9
Drug: Placebo
PF-07304814 is an anti-viral, formulated for intravenous delivery
Placebo will be formulated for intravenous delivery
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 1: SAD
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.
Time frame: Day 1 to 37 days
Number of Participants With TEAEs, SAEs, and Severe TEAEs - Part 2: MAD
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a treatment-emergent adverse event (TEAE) if the event started during the effective duration of treatment.
Time frame: Day 1 to 41 days
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 1: SAD
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment.
Time frame: Day 1 up to 37 days
Number of Participants With Discontinuations From Study/Study Drug or Dose Reduction Due to TEAEs - Part 2: MAD
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.
Time frame: Day 1 to 41 days
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 1: SAD
Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes, basophiles; Clinical Chemistry - aspartate aminotransferase, alanine aminotransferase, calcium, bicarbonate, glucose, glucose -FASTING; Urinalysis - urine glucose, urine hemoglobin, urobilinogen and urine erythrocytes (per high power field). Baseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal.
Time frame: Day 1 up to 6 days
Number of Participants With Laboratory Abnormality Without Regard to Baseline Abnormality - Part 2: MAD
Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular, hemoglobin; Clinical Chemistry - alanine aminotransferase, protein, albumin, urea nitrogen, creatinine, HDL cholesterol, triglycerides, calcium, phosphate, bicarbonate, glucose; Urinalysis - urine glucose, ketones, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase, urine erythrocytes (per high power field), urine leukocytes (Scalar). Baseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal
Time frame: Day 1 up to 41 days
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD
Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline (pre-dose Day 1), Day 1-30 minutes, 2 hours, 6 hour, and 12 hours; 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).
Summary of Baseline and Change From Baseline in Systolic and Diastolic Blood Pressure at Day2,3,4,5, and 6 (120 Hours), Day7 (Follow-up 1), Day10 (Follow-up 2), Day14 (Follow-up 3), Between Day34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD
Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline (pre-dose Day 1), Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET) .
Summary of Baseline and Change From Baseline in Pulse Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD
Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline (pre-dose Day 1), 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day 1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).
Summary of Baseline and Change From Baseline in Pulse Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD
Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).
Summary of Baseline and Change From Baseline in Temperature at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD
Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).
Summary of Baseline and Change From Baseline in Temperature at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD
Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD
Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2).
Summary of Baseline and Change From Baseline in Respiratory Rate at Day 2, 3, 4, 5, and 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Between Day 34-41 (Follow-up 4), and/or Early Termination - Part 2: MAD
Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
Time frame: Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41) and/or early termination (ET).
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at 24 Hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD
Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement. SpO2 = arterial oxygen saturation.
Time frame: Baseline (pre-dose Day 1); Day1-24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)
Summary of Baseline and Change From Baseline in Pulse Oximetry/SpO2 at Day 2, 3, 4, 5; 6 (120hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41), and/or Early Termination-Part 2: MAD
Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement. SpO2 = arterial oxygen saturation.
Time frame: Baseline (pre-dose Day 1); Day 2, 3, 4, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination (ET).
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.
Time frame: Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)
Summary of Baseline and Change From Baseline in ECG Mean Heart Rate at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.
Time frame: Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET)
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 1 (30 Minutes, 2 Hours, 6 Hour, and 12 Hours; 24 Hours [End of Treatment]), Day 3 (Follow-up 1) and Day 6 (Follow-up 2) - Part 1: SAD
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.
Time frame: Baseline (pre-dose Day 1); 30 minutes, 2 hours, 6 hour, and 12 hours (post-dose Day1); 24 hours (End of Treatment), Day 3 (Follow-up 1) and Day 6 (Follow-up 2)
Summary of Baseline and Change From Baseline in PR, QRS, QT and QTcF Intervals at Day 2, 3, 5, 6 (120 Hours), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (Between Day 34-41) and/or Early Termination- Part 2: MAD
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.
Time frame: Baseline (pre-dose Day 1); Day 2, 3, 5; 120 hours (End of Treatment), Day 7 (Follow-up 1), Day 10 (Follow-up 2), Day 14 (Follow-up 3), Follow-up 4 (between Day 34-41), and/or early termination(ET)
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at 24 Hours (End of Infusion) - Part 1: SAD
C24 was defined as concentration at 24 hours. 24-hour PK draw was approximately 4 hours post end of infusion which corresponded to 28 hours.
Time frame: Pre-dose and 6 hours post-dose on Day 1; 24 hours; 48 hours; and/or early termination.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameter: Concentration at 120 Hours (End of Infusion) - Part 2: MAD
C120 was defined as concentration at 120 hours. Blood sample collection at approximately at 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.
Time frame: Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Maximum Observed Concentration (Cmax) - Part 2: MAD
Cmax was defined as maximum observed concentration. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.
Time frame: Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: t½ - Part 2: MAD
t½ was defined as terminal half-life. Blood sample collection at approximately within 30 minutes before end of infusion (\~120 hours), and at 2 and 6 hours post the end of the infusion, which correspond to approximately 122h and 126h post the start of infusion.
Time frame: Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.
PF-07304814 (Prodrug) and PF-00835231 (Active Moiety) Plasma PK Parameters: Concentration at Steady State (Css) - Part 2: MAD
Css was defined as concentration at steady state. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.
Time frame: Pre-dose on Day1; Day 2, 3, 5 and 6 (end of treatment day), 7 (Follow-up 1), and/or early termination.
| Milestone | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|---|---|---|---|
| Started | 2 | 2 | 2 | 2 | 6 | 7 | 4 |
| Completed | 2 | 2 | 2 | 2 | 6 | 7 | 3 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Milestone | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|---|---|---|---|
| Started | 2 | 2 | 2 | 2 | 6 | 7 | 4 |
| Completed | 2 | 2 | 2 | 1 | 6 | 7 | 3 |
| Not completed | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.
| Participants | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| All-causality TEAEs | 1 | 1 | 2 | 2 |
| Treatment-related TEAEs | 0 | 0 | 1 | 1 |
| All-causality SAEs | 1 | 0 | 1 | 1 |
| Treatment-related SAEs | 0 | 0 | 0 | 0 |
| All-causality severe AEs | 1 | 1 | 1 | 1 |
| Treatment-related severe AEs | 0 | 0 | 0 | 0 |
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as an AE: 1. resulting in death, 2. was life-threatening, 3. required inpatient hospitalization or prolongation of existing hospitalization, 4. resulted in persistent disability, 5. was a congenital anomaly/birth defect, or considered to be an important medical event. An adverse event was considered a treatment-emergent adverse event (TEAE) if the event started during the effective duration of treatment.
| Participants | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| All-causality TEAEs | 2 | 4 | 3 |
| Treatment-related TEAEs | 0 | 0 | 1 |
| All-causality SAEs | 1 | 2 | 1 |
| Treatment-related SAEs | 0 | 0 | 0 |
| All-causality severe AEs | 0 | 2 | 1 |
| Treatment-related severe AEs | 0 | 0 | 0 |
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started during the effective duration of treatment.
| Participants | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| Discontinued from study due to adverse events | 0 | 0 | 0 | 0 |
| Discontinuation from study drug due to AE and continued study | 0 | 0 | 0 | 0 |
| Dose reduced or temporary discontinuation due to adverse events | 0 | 0 | 0 | 0 |
An adverse event (AE) was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a Treatment-Emergent Adverse Event (TEAE) if the event started during the effective duration of treatment.
| Participants | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| Discontinued from study due to adverse events | 0 | 0 | 1 |
| Discontinuation from study drug due to AE and continued study | 0 | 0 | 0 |
| Dose reduced or temporary discontinuation due to adverse events | 1 | 0 | 0 |
Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes, basophiles; Clinical Chemistry - aspartate aminotransferase, alanine aminotransferase, calcium, bicarbonate, glucose, glucose -FASTING; Urinalysis - urine glucose, urine hemoglobin, urobilinogen and urine erythrocytes (per high power field). Baseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal.
| Participants | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| Lymphocytes (10^3/mm3) < 0.8*LLN | 1 | 2 | 0 | 1 |
| Basophils (10^3/mm3) > 1.2*ULN | 0 | 0 | 1 | 0 |
| Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 | 1 | 0 | 1 |
| Alanine Aminotransferase (U/L) > 3.0*ULN | 0 | 1 | 1 | 0 |
| Calcium (mg/dL) < 0.9*LLN | 0 | 0 | 1 | 0 |
| Bicarbonate (mEq/L) < 0.9*LLN | 0 | 1 | 1 | 1 |
| Glucose (mg/dL) > 1.5*ULN | 0 | 1 | 0 | 2 |
| Glucose - FASTING (mg/dL) >1.5*ULN | 1 | 0 | 2 | 0 |
| URINE Glucose ≥ 1 | 1 | 0 | 0 | 0 |
| URINE Hemoglobin ≥ 1 | 0 | 0 | 0 | 1 |
| Urobilinogen ≥ 1 | 0 | 0 | 0 | 1 |
| URINE Erythrocytes (/HPF) ≥ 20 | 0 | 0 | 0 | 1 |
Laboratory abnormalities reported in at least 1 participant are presented in this OM, including: Hematology - lymphocytes hemoglobin, hematocrit, erythrocytes, ery. mean corpuscular volume, ery. mean corpuscular, hemoglobin; Clinical Chemistry - alanine aminotransferase, protein, albumin, urea nitrogen, creatinine, HDL cholesterol, triglycerides, calcium, phosphate, bicarbonate, glucose; Urinalysis - urine glucose, ketones, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase, urine erythrocytes (per high power field), urine leukocytes (Scalar). Baseline was the last pre-dose measurement. LLN = lower limit of normal, ULN = upper limit of normal
| Participants | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| Hemoglobin (g/dL)<0.8*LLN | 0 | 2 | 1 |
| Hematocrit (%)<0.8x LLN | 0 | 2 | 0 |
| Erythrocytes (10^6/mm3)<0.8x LLN | 0 | 1 | 0 |
| Ery. mean corpuscular volume (um^3)<0.9*LLN | 0 | 1 | 1 |
| Ery. mean corpuscular hemoglobin (pg/cell)<0.9*LLN | 0 | 1 | 1 |
| Lymphocytes (10^3/mm3)<0.8x LLN | 0 | 3 | 3 |
| Alanine aminotransferase (U/L)>3.0*ULN | 0 | 1 | 1 |
| Protein (g/dL)<0.8x LLN | 0 | 1 | 1 |
| Albumin (g/dL) <0.8x LLN | 1 | 0 | 1 |
| Urea nitrogen (mg/dL)>1.3x ULN | 0 | 0 | 1 |
| Creatinine (mg/dL)>1.3x ULN | 0 | 0 | 1 |
| HDL cholesterol (mg/dL)<0.8x LLN | 2 | 3 | 1 |
| Triglycerides (mg/dL)>1.3x ULN | 1 | 1 | 0 |
| Calcium (mg/dL)<0.9x LLN | 1 | 1 | 0 |
| Phosphate (mg/dL)<0.8x LLN | 0 | 1 | 0 |
| Bicarbonate (mEq/L)<0.9x LLN | 2 | 4 | 3 |
| Glucose (mg/dL)>1.5x ULN | 3 | 6 | 2 |
| URINE glucose≥1 | 1 | 1 | 0 |
| Ketones≥1 | 0 | 1 | 0 |
| Urine hemoglobin ≥ 1 | 1 | 2 | 1 |
| Urobilinogen≥1 | 1 | 2 | 1 |
| Nitrite≥1 | 1 | 0 | 0 |
| Leukocyte esterase ≥ 1 | 1 | 2 | 0 |
| Urine erythrocytes (/HPF)≥20 | 1 | 2 | 0 |
| Urine leukocytes (Scalar)≥20 | 0 | 1 | 0 |
Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.
| mmHg | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| Systolic blood pressure: Baseline | 116.0 ± 4.24 | 134.5 ± 13.44 | 108.0 ± 14.14 | 127.5 ± 30.41 |
| Systolic blood pressure: Change from Baseline: Day 1- 30 minutes | 6.0 ± 18.38 | -12.5 ± 12.02 | -4.0 ± 12.73 | 9.5 ± 17.68 |
| Systolic blood pressure: Change from Baseline: Day 1 - 2 hours | 12.0 ± 22.63 | -20.0 ± 11.31 | 4.0 ± 2.83 | 3.5 ± 20.51 |
| Systolic blood pressure: Change from Baseline: Day 1 - 6 hours | -1.5 ± 14.85 | -20.5 ± 13.44 | 0.0 ± 7.07 | 16.5 ± 24.75 |
| Systolic blood pressure: Change from Baseline: Day 1 - 12 hours | -8.0 ± 18.38 | -6.5 ± 26.16 | -2.5 ± 4.95 | 10.0 ± 5.66 |
| Systolic blood pressure: Change from Baseline: End of Treatment | -5.0 ± 16.97 | -17.0 ± NA | 0.0 ± 8.49 | -1.0 ± 5.66 |
| Systolic blood pressure: Change from Baseline: Follow Up 1 | 8.0 ± 11.31 | -16.5 ± 21.92 | -3.0 ± 9.90 | 13.5 ± 3.54 |
| Systolic blood pressure: Change from Baseline: Follow Up 2 | 17.0 ± NA | -20.0 ± NA | -6.0 ± NA | -14.5 ± 27.58 |
| Diastolic blood pressure: Baseline | 64.0 ± 9.90 | 59.0 ± 21.21 | 68.5 ± 13.44 | 76.5 ± 9.19 |
| Diastolic blood pressure: Change from Baseline: Day 1 - 30 minutes | 5.0 ± 5.66 | 16.0 ± 14.14 | -5.0 ± 8.49 | 6.0 ± 9.90 |
| Diastolic blood pressure: Change from Baseline: Day 1 - 2 hours | 9.5 ± 12.02 | 11.5 ± 7.78 | -2.0 ± 4.24 | 3.0 ± 11.31 |
| Diastolic blood pressure: Change from Baseline: Day 1 - 6 hours | -1.5 ± 6.36 | 8.5 ± 17.68 | -8.0 ± 7.07 | 6.5 ± 7.78 |
| Diastolic blood pressure: Change from Baseline: Day 1 - 12 hours | 9.0 ± 9.90 | 13.0 ± 16.97 | -8.5 ± 2.12 | -1.0 ± 0.00 |
| Diastolic blood pressure: Change from Baseline: End of Treatment | -1.0 ± 0.00 | 23.0 ± NA | -7.5 ± 6.36 | -4.5 ± 0.71 |
| Diastolic blood pressure: Change from Baseline: Follow Up 1 | 17.0 ± 2.83 | 6.0 ± 2.83 | -6.0 ± 1.41 | 8.5 ± 2.12 |
| Diastolic blood pressure: Change from Baseline: Follow Up 2 | 12.0 ± NA | 17.0 ± NA | -11.0 ± NA | -2.0 ± 12.73 |
Absolute baseline values and changes from baseline in supine systolic and diastolic blood pressure were summarized by treatment and time post-dose. Blood pressure was assessed in the supine position after at least 5 minutes of rest in a quiet setting without distractions. Baseline was defined as the last pre-dose measurement.
| mmHg | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| Systolic blood pressure: Baseline | 105.3 ± 18.08 | 127.6 ± 13.64 | 116.5 ± 14.29 |
| Systolic blood pressure: Change from Baseline: Day 2 | 4.8 ± 10.34 | 1.4 ± 14.20 | -4.3 ± 8.42 |
| Systolic blood pressure: Change from Baseline: Day 3 | 15.5 ± 14.15 | -4.9 ± 16.92 | 10.8 ± 24.70 |
| Systolic blood pressure: Change from Baseline: Day 4 | -1.2 ± 12.54 | -13.1 ± 13.59 | -18.0 ± 6.00 |
| Systolic blood pressure: Change from Baseline: Day 5 | 3.2 ± 10.28 | -4.6 ± 14.14 | -12.3 ± 6.66 |
| Systolic blood pressure: Change from Baseline: End of Treatment | 3.7 ± 14.85 | -11.6 ± 12.71 | -11.0 ± 6.08 |
| Systolic blood pressure: Change from Baseline: Early Termination | — | — | 11.0 ± NA |
| Systolic blood pressure: Change from Baseline: Follow Up 1 | 5.0 ± 14.14 | -7.7 ± 10.83 | 4.5 ± 17.29 |
| Systolic blood pressure: Change from Baseline: Follow Up 2 | 21.5 ± 17.62 | 1.0 ± NA | 24.0 ± 48.08 |
| Systolic blood pressure: Change from Baseline: Follow Up 3 | 19.0 ± 14.07 | -1.0 ± 2.83 | 11.7 ± 17.01 |
| Systolic blood pressure: Change from Baseline: Follow Up 4 | 15.0 ± 2.83 | -2.7 ± 6.66 | 15.0 ± NA |
| Diastolic blood pressure: Baseline | 63.8 ± 11.39 | 78.7 ± 7.87 | 72.0 ± 12.52 |
| Diastolic blood pressure: Change from Baseline: Day 2 | 4.7 ± 10.52 | -2.4 ± 7.48 | 1.0 ± 9.83 |
| Diastolic blood pressure: Change from Baseline: Day 3 | 7.8 ± 10.96 | -9.4 ± 13.15 | 2.3 ± 9.54 |
| Diastolic blood pressure: Change from Baseline: Day 4 | 2.7 ± 8.57 | -7.4 ± 9.32 | -11.7 ± 4.93 |
| Diastolic blood pressure: Change from Baseline: Day 5 | 2.7 ± 10.05 | -9.6 ± 11.62 | 2.0 ± 11.27 |
| Diastolic blood pressure: Change from Baseline: End of Treatment | 2.5 ± 8.96 | -7.9 ± 17.00 | -13.0 ± 2.00 |
| Diastolic blood pressure: Change from Baseline: Early Termination | — | — | 11.0 ± NA |
| Diastolic blood pressure: Change from Baseline: Follow Up 1 | 4.8 ± 11.34 | -6.7 ± 13.86 | -5.8 ± 12.04 |
| Diastolic blood pressure: Change from Baseline: Follow Up 2 | 15.5 ± 13.48 | -34.0 ± NA | -3.0 ± 1.41 |
| Diastolic blood pressure: Change from Baseline: Follow Up 3 | 13.0 ± 13.64 | -14.5 ± 13.44 | 5.0 ± 21.63 |
| Diastolic blood pressure: Change from Baseline: Follow Up 4 | 11.0 ± 14.14 | -4.3 ± 12.66 | 12.0 ± NA |
Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
| bpm | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| Pulse rate: Baseline | 83.0 ± 2.83 | 74.5 ± 4.95 | 66.0 ± 16.97 | 75.5 ± 6.36 |
| Pulse rate: Change from Baseline: Day 1 - 30 minutes | 1.0 ± NA | 10.0 ± NA | -1.0 ± NA | 6.5 ± 0.71 |
| Pulse rate: Change from Baseline: Day 1 - 2 hours | -2.0 ± NA | 2.5 ± 3.54 | -5.0 ± NA | 16.0 ± 24.04 |
| Pulse rate: Change from Baseline: Day 1 - 6 hours | -6.0 ± NA | -8.0 ± NA | -7.0 ± NA | — |
| Pulse rate: Change from Baseline: Day 1 - 12 hours | -12.0 ± NA | 0.0 ± 0.00 | -11.0 ± 1.41 | 6.0 ± 7.07 |
| Pulse rate: Change from Baseline: End of Treatment | -5.5 ± 0.71 | -4.5 ± 17.68 | 2.5 ± 10.61 | -17.0 ± NA |
| Pulse rate: Change from Baseline: Follow Up 1 | -2.5 ± 7.78 | -7.0 ± 1.41 | -1.0 ± 1.41 | 15.0 ± NA |
| Pulse rate: Change from Baseline: Follow Up 2 | 4.0 ± NA | 3.0 ± NA | 5.0 ± NA | 5.0 ± 9.90 |
Absolute baseline values and changes from baseline in pulse rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
| bpm | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| Pulse rate: Baseline | 74.2 ± 10.59 | 80.9 ± 13.15 | 90.3 ± 30.38 |
| Pulse rate: Change from Baseline: Day 2 | -4.0 ± 16.82 | -5.4 ± 10.64 | -1.5 ± 4.12 |
| Pulse rate: Change from Baseline: Day 3 | 3.5 ± 11.52 | -6.6 ± 20.90 | -3.0 ± 8.60 |
| Pulse rate: Change from Baseline: Day 4 | -6.0 ± 17.47 | -10.6 ± 10.39 | -18.3 ± 24.79 |
| Pulse rate: Change from Baseline: Day 5 | -2.3 ± 11.11 | -8.4 ± 12.61 | -12.0 ± 22.07 |
| Pulse rate: Change from Baseline: End of Treatment | -7.8 ± 20.65 | -9.1 ± 16.34 | -19.7 ± 45.39 |
| Pulse rate: Change from Baseline: Early Termination | — | — | -3.0 ± NA |
| Pulse rate: Change from Baseline: Follow Up 1 | -1.3 ± 9.93 | -9.7 ± 12.58 | -11.3 ± 32.46 |
| Pulse rate: Change from Baseline: Follow Up 2 | 13.0 ± 9.83 | -38.0 ± NA | -25.5 ± 24.75 |
| Pulse rate: Change from Baseline: Follow Up 3 | 8.8 ± 10.24 | 6.0 ± 29.70 | -7.7 ± 28.36 |
| Pulse rate: Change from Baseline: Follow Up 4 | 12.0 ± 12.73 | 8.3 ± 24.95 | 12.0 ± NA |
Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
| Degree Celsius | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| Temperature: Baseline | 37.6 ± 0.14 | 37.0 ± 0.28 | 36.5 ± 0.14 | 37.1 ± 0.99 |
| Temperature: Change from Baseline: Day 1 - 30 minutes | 0.2 ± 0.21 | -0.2 ± 0.21 | 0.1 ± 0.07 | 0.2 ± 0.00 |
| Temperature: Change from Baseline: Day 1 - 2 hours | 0.1 ± 0.49 | -0.1 ± 0.07 | 0.1 ± 0.14 | -0.1 ± 0.57 |
| Temperature: Change from Baseline: Day 1 - 6 hours | -0.4 ± 0.28 | 0.0 ± 0.14 | 0.2 ± 0.07 | 0.1 ± 0.71 |
| Temperature: Change from Baseline: Day 1 - 12 hours | -0.1 ± 0.99 | -0.5 ± 0.14 | 0.1 ± 0.00 | 0.7 ± 0.42 |
| Temperature: Change from Baseline: End of Treatment | -0.7 ± 0.64 | -0.1 ± NA | 0.3 ± 0.35 | 0.3 ± 0.64 |
| Temperature: Change from Baseline: Follow Up 1 | -0.9 ± 0.78 | -0.7 ± 0.07 | 0.3 ± 0.07 | -0.3 ± 0.85 |
| Temperature: Change from Baseline: Follow Up 2 | -0.9 ± NA | 2.0 ± NA | 0.3 ± NA | 0.1 ± 0.35 |
Absolute baseline values and changes from baseline in temperature were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
| Degree Celsius | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| Temperature: Baseline | 36.7 ± 0.79 | 36.7 ± 0.35 | 36.3 ± 0.73 |
| Temperature: Change from Baseline: Day 2 | -0.4 ± 0.88 | -0.3 ± 0.50 | 0.2 ± 0.29 |
| Temperature: Change from Baseline: Day 3 | -0.2 ± 0.84 | -0.3 ± 0.43 | 0.1 ± 0.43 |
| Temperature: Change from Baseline: Day 4 | -0.3 ± 0.91 | -0.4 ± 0.45 | 0.0 ± 0.40 |
| Temperature: Change from Baseline: Day 5 | -0.4 ± 0.97 | -0.6 ± 0.60 | 0.4 ± 0.55 |
| Temperature: Change from Baseline: End of Treatment | -0.4 ± 0.91 | -0.6 ± 0.59 | 0.5 ± 0.45 |
| Temperature: Change from Baseline: Early Termination | — | — | -0.3 ± NA |
| Temperature: Change from Baseline: Follow Up 1 | -0.4 ± 0.91 | -0.6 ± 0.46 | 0.7 ± 0.17 |
| Temperature: Change from Baseline: Follow Up 2 | -0.1 ± 1.21 | -0.1 ± NA | 0.7 ± 0.57 |
| Temperature: Change from Baseline: Follow Up 3 | -0.4 ± 1.05 | -0.1 ± 0.21 | 0.7 ± 1.08 |
| Temperature: Change from Baseline: Follow Up 4 | -1.0 ± 0.64 | 0.2 ± 0.67 | -0.2 ± NA |
Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
| breaths per minute | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| Respiratory rate: Baseline | 21.0 ± 1.41 | 20.5 ± 3.54 | 23.0 ± 7.07 | 20.0 ± 2.83 |
| Respiratory rate: Change from Baseline: Day 1 - 30 minutes | 0.0 ± NA | -1.0 ± 4.24 | -1.0 ± 1.41 | -0.5 ± 0.71 |
| Respiratory rate: Change from Baseline: Day 1 - 2 hours | 0.0 ± NA | -1.0 ± 4.24 | -1.0 ± 1.41 | 6.5 ± 7.78 |
| Respiratory rate: Change from Baseline: Day 1 - 6 hours | -2.0 ± NA | -0.5 ± 0.71 | -0.5 ± 0.71 | — |
| Respiratory rate: Change from Baseline: Day 1 - 12 hours | -1.0 ± NA | -5.5 ± 10.61 | -2.5 ± 4.95 | 0.0 ± 0.00 |
| Respiratory rate: Change from Baseline: End of Treatment | -2.5 ± 0.71 | -0.5 ± 2.12 | 2.5 ± 3.54 | 7.0 ± NA |
| Respiratory rate: Change from Baseline: Follow Up 1 | -4.0 ± 2.83 | 0.5 ± 7.78 | -3.5 ± 4.95 | -4.0 ± NA |
| Respiratory rate: Change from Baseline: Follow Up 2 | -8.0 ± NA | 4.0 ± NA | -8.0 ± NA | -2.0 ± 5.66 |
Absolute baseline values and changes from baseline in respiratory rate were summarized by treatment and time post-dose. Baseline was defined as the last pre-dose measurement.
| Breaths per minute | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| Respiratory rate: Baseline | 23.5 ± 3.45 | 22.4 ± 5.59 | 21.0 ± 4.69 |
| Respiratory rate: Change from Baseline: Day 2 | -3.0 ± 7.10 | -1.7 ± 7.45 | -0.5 ± 5.07 |
| Respiratory rate: Change from Baseline: Day 3 | 1.0 ± 8.99 | -3.1 ± 4.26 | 1.0 ± 4.97 |
| Respiratory rate: Change from Baseline: Day 4 | -1.8 ± 3.76 | -4.0 ± 5.69 | 4.0 ± 5.00 |
| Respiratory rate: Change from Baseline: Day 5 | -2.2 ± 5.78 | -2.9 ± 2.04 | -0.7 ± 2.08 |
| Respiratory rate: Change from Baseline: End of Treatment | -3.3 ± 4.27 | -2.3 ± 5.62 | -2.3 ± 3.51 |
| Respiratory rate: Change from Baseline: Early Termination | — | — | -4.0 ± NA |
| Respiratory rate: Change from Baseline: Follow Up 1 | -3.5 ± 4.55 | -3.9 ± 4.88 | -3.0 ± 1.00 |
| Respiratory rate: Change from Baseline: Follow Up 2 | -5.8 ± 6.50 | -2.0 ± NA | -1.5 ± 2.12 |
| Respiratory rate: Change from Baseline: Follow Up 3 | -6.8 ± 5.74 | -10.0 ± NA | 1.3 ± 10.12 |
| Respiratory rate: Change from Baseline: Follow Up 4 | -6.0 ± 5.66 | 1.3 ± 4.73 | -3.0 ± NA |
Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement. SpO2 = arterial oxygen saturation.
| percentage of SpO2 | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| Baseline: Oxygen Received Throughout | 92.0 ± NA | 90.0 ± NA | 98.0 ± NA | 94.5 ± 0.71 |
| Baseline: Oxygen Received at Some Point During Study | — | 91.0 ± NA | 95.0 ± NA | — |
| Baseline: Oxygen Never Received | 93.0 ± NA | — | — | — |
| Change from Baseline: End of Treatment: Oxygen Received Throughout: | 3.0 ± NA | 5.0 ± NA | 0.0 ± NA | -0.5 ± 0.71 |
| Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study | — | 5.0 ± NA | -4.0 ± NA | — |
| Change from Baseline: End of Treatment: Oxygen Never Received | 1.0 ± NA | — | — | — |
| Change from Baseline: Follow Up 1: Oxygen Received Throughout | 3.0 ± NA | 1.0 ± NA | 0.0 ± NA | 0.0 ± NA |
| Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study | — | 5.0 ± NA | 1.0 ± NA | — |
| Change from Baseline: Follow Up 1: Oxygen Never Received | 1.0 ± NA | — | — | — |
| Change from Baseline: Follow Up 2: Oxygen Received Throughout | 0.0 ± NA | 5.0 ± NA | -5.0 ± NA | -1.5 ± 0.71 |
Percent SpO2 values at baseline and changes from baseline were summarized for participants in 3 categories: (1) participants who received supplemental oxygen throughout, (2) participants who received supplemental oxygen at some point during the study, and (3) participants who never received supplemental oxygen. Baseline of pulse oximetry/SpO2 was defined as the last pre-dose measurement. SpO2 = arterial oxygen saturation.
| percentage of SpO2 | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| Baseline: Oxygen Received Throughout | 93.3 ± 3.77 | 96.3 ± 0.58 | 60.0 ± NA |
| Baseline: Oxygen Received at Some Point During Study | 97.0 ± 0.00 | 96.0 ± 2.65 | 97.3 ± 0.58 |
| Baseline: Oxygen Never Received | — | 98.0 ± NA | — |
| Change from Baseline: Day 2: Oxygen Received Throughout | 2.0 ± 3.74 | -3.3 ± 2.08 | 34.0 ± NA |
| Change from Baseline: Day 2: Oxygen Received at Some Point During Study | 1.0 ± 0.00 | -1.0 ± 1.0 | -2.7 ± 2.08 |
| Change from Baseline: Day 2: Oxygen Never Received | — | 2.0 ± NA | — |
| Change from Baseline: Day 3: Oxygen Received Throughout | 1.3 ± 3.77 | -2.3 ± 2.08 | 31.0 ± NA |
| Change from Baseline: Day 3: Oxygen Received at Some Point During Study | -2.0 ± 2.83 | 0.0 ± 1.00 | -1.0 ± 1.0 |
| Change from Baseline: Day 3: Oxygen Never Received | — | -3.0 ± NA | — |
| Change from Baseline: Day 4: Oxygen Received Throughout | 2.0 ± 2.45 | -0.7 ± 2.52 | 29.0 ± NA |
| Change from Baseline: Day 4: Oxygen Received at Some Point During Study | -1.0 ± 0.00 | -0.7 ± 0.58 | -3.5 ± 2.12 |
| Change from Baseline: Day 4: Oxygen Never Received | — | -3.0 ± NA | — |
| Change from Baseline: Day 5: Oxygen Received Throughout | 3.0 ± 4.08 | -1.3 ± 3.79 | 25.0 ± NA |
| Change from Baseline: Day 5: Oxygen Received at Some Point During Study | -1.5 ± 0.71 | -1.3 ± 2.08 | -5.5 ± 3.54 |
| Change from Baseline: Day 5: Oxygen Never Received | — | -2.0 ± NA | — |
| Change from Baseline: End of Treatment: Oxygen Received Throughout | 0.8 ± 3.86 | -1.0 ± 1.73 | 34.0 ± NA |
| Change from Baseline: End of Treatment: Oxygen Received at Some Point During Study | 0.0 ± 2.83 | 0.3 ± 2.08 | -5.5 ± 0.71 |
| Change from Baseline: End of Treatment: Oxygen Never Received | — | 0.0 ± NA | — |
| Change from Baseline: Early Termination: Oxygen Received at Some Point During Study | — | — | -1.0 ± NA |
| Change from Baseline: Follow Up 1: Oxygen Received Throughout | 2.0 ± 2.45 | -1.0 ± 0.00 | 36.0 ± NA |
| Change from Baseline: Follow Up 1: Oxygen Received at Some Point During Study | -2.5 ± 0.71 | 0.0 ± 1.73 | -3.0 ± 2.83 |
| Change from Baseline: Follow Up 1: Oxygen Never Received | — | -1.0 ± NA | — |
| Change from Baseline: Follow Up 2: Oxygen Received Throughout | 3.3 ± 4.04 | -2.0 ± NA | 31.0 ± NA |
| Change from Baseline: Follow Up 2: Oxygen Received at Some Point During Study | -2.0 ± NA | — | 1.0 ± NA |
| Change from Baseline: Follow Up 3: Oxygen Received Throughout | 3.7 ± 4.04 | -2.0 ± NA | 31.0 ± NA |
| Change from Baseline: Follow Up 3: Oxygen Received at Some Point During Study | 0.0 ± NA | 2.0 ± NA | 0.5 ± 0.71 |
| Change from Baseline: Follow Up 4: Oxygen Received Throughout | 3.0 ± 1.41 | -0.5 ± 3.54 | — |
| Change from Baseline: Follow Up 4: Oxygen Received at Some Point During Study | — | 1.0 ± NA | -3.0 ± NA |
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.
| Beats per minute | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| ECG mean heart rate: Baseline | 87.5 ± 3.54 | 71.5 ± 4.95 | 66.0 ± 15.56 | 71.0 ± 7.07 |
| ECG mean heart rate: Change from Baseline: Day 1 - 30 minutes | -3.5 ± 3.54 | — | -5.5 ± 0.71 | — |
| ECG mean heart rate: Change from Baseline: Day 1 - 2 hours | 2.0 ± 8.49 | — | -4.0 ± 2.83 | — |
| ECG mean heart rate: Change from Baseline: Day 1 - 6 hours | -12.5 ± 4.95 | 2.5 ± 0.71 | -13.5 ± 9.19 | 7.5 ± 13.44 |
| ECG mean heart rate: Change from Baseline: Day 1 - 12 hours | -7.0 ± 11.31 | 3.0 ± 5.66 | -9.5 ± 3.54 | 8.5 ± 10.61 |
| ECG mean heart rate: Change from Baseline: End of Treatment | -7.0 ± 5.66 | -9.0 ± 7.07 | 2.5 ± 10.61 | -4.0 ± 2.83 |
| ECG mean heart rate: Change from Baseline: Follow Up 1 | -8.0 ± 11.31 | -2.0 ± NA | -3.5 ± 0.71 | 8.0 ± 5.66 |
| ECG mean heart rate: Change from Baseline: Follow Up 2 | -14.0 ± NA | 1.0 ± NA | 1.0 ± NA | -8.0 ± NA |
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.
| Beats per minute | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| ECG mean heart rate: Baseline | 70.2 ± 9.02 | 80.1 ± 11.29 | 85.0 ± 41.16 |
| ECG mean heart rate: Change from Baseline: Day 2 | -4.7 ± 8.52 | -6.0 ± 18.90 | -0.7 ± 2.08 |
| ECG mean heart rate: Change from Baseline: Day 3 | -8.7 ± 15.49 | -12.0 ± 15.01 | -7.5 ± 18.91 |
| ECG mean heart rate: Change from Baseline: Day 5 | -6.7 ± 13.28 | -9.0 ± 8.04 | -13.7 ± 27.61 |
| ECG mean heart rate: Change from Baseline: End of Treatment | -8.7 ± 16.65 | -8.4 ± 13.46 | -15.0 ± 42.79 |
| ECG mean heart rate: Change from Baseline: Early Termination | — | — | 9.0 ± NA |
| ECG mean heart rate: Change from Baseline: Follow Up 1 | 2.8 ± 17.73 | -6.9 ± 8.63 | 21.0 ± 10.44 |
| ECG mean heart rate: Change from Baseline: Follow Up 2 | 7.0 ± 12.68 | -26.0 ± NA | 2.0 ± NA |
| ECG mean heart rate: Change from Baseline: Follow Up 3 | 8.5 ± 12.07 | -12.5 ± 16.26 | 6.0 ± NA |
| ECG mean heart rate: Change from Baseline: Follow Up 4 | -6.0 ± NA | 8.0 ± 21.38 | 21.0 ± NA |
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.
| Millisecond | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion |
|---|---|---|---|---|
| PR interval: Baseline | 153.0 ± 5.66 | 165.0 ± 29.70 | 171.0 ± 16.97 | 183.5 ± 10.61 |
| PR interval: Change from Baseline: Day 1 - 30 minutes | -7.0 ± 1.41 | — | -1.5 ± 0.71 | — |
| PR interval: Change from Baseline: Day 1 - 2 hours | -6.0 ± 14.14 | — | -2.5 ± 2.12 | — |
| PR interval: Change from Baseline: Day 1 - 6 hours | -3.5 ± 4.95 | -1.5 ± 7.78 | -2.5 ± 4.95 | -14.5 ± 4.95 |
| PR interval: Change from Baseline: Day 1 - 12 hours | -4.0 ± 11.31 | -11.0 ± 19.80 | 0.5 ± 3.54 | -19.5 ± 4.95 |
| PR interval: Change from Baseline: End of Treatment | -8.0 ± 2.83 | 1.5 ± 10.61 | -7.5 ± 6.36 | -7.0 ± 5.66 |
| PR interval: Change from Baseline: Follow Up 1 | -3.5 ± 12.02 | 5.0 ± NA | -2.0 ± 12.73 | -16.5 ± 6.36 |
| PR interval: Change from Baseline: Follow Up 2 | 9.0 ± NA | -1.0 ± NA | -7.0 ± NA | -11.0 ± NA |
| QRS interval: Baseline | 92.5 ± 2.12 | 99.0 ± 4.24 | 95.0 ± 8.49 | 103.0 ± 4.24 |
| QRS interval: Change from Baseline: Day 1 - 30 minutes | -2.0 ± 5.66 | — | 1.0 ± 2.83 | — |
| QRS interval: Change from Baseline: Day 1 - 2 hours | -2.5 ± 0.71 | — | 1.0 ± 1.41 | — |
| QRS interval: Change from Baseline: Day 1 - 6 hours | -2.5 ± 2.12 | -3.0 ± 12.73 | -2.0 ± 2.83 | 0.0 ± 1.41 |
| QRS interval: Change from Baseline: Day 1 - 12 hours | -2.5 ± 0.71 | 0.0 ± 5.66 | -3.0 ± 0.00 | -0.5 ± 3.54 |
| QRS interval: Change from Baseline: End of Treatment | 1.5 ± 6.36 | 0.0 ± 1.41 | 0.0 ± 4.24 | 0.5 ± 0.71 |
| QRS interval: Change from Baseline: Follow Up 1 | 1.0 ± 0.00 | -1.0 ± NA | -5.0 ± 1.41 | 0.0 ± 2.83 |
| QRS interval: Change from Baseline: Follow Up 2 | -1.0 ± NA | -2.0 ± NA | 2.0 ± NA | 1.0 ± NA |
| QT interval: Baseline | 348.5 ± 30.41 | 401.0 ± 48.08 | 397.5 ± 30.41 | 389.0 ± 22.63 |
| QT interval: Change from Baseline: Day 1 - 30 minutes | 5.5 ± 21.92 | — | 1.0 ± 12.73 | — |
| QT interval: Change from Baseline: Day 1 - 2 hours | -3.5 ± 12.02 | — | -1.0 ± 14.14 | — |
| QT interval: Change from Baseline: Day 1 - 6 hours | 24.5 ± 10.61 | -16.5 ± 24.75 | 19.5 ± 38.89 | -13.5 ± 28.99 |
| QT interval: Change from Baseline: Day 1 - 12 hours | 28.5 ± 30.41 | -1.0 ± 1.41 | 30.0 ± 19.80 | -20.0 ± 28.28 |
| QT interval: Change from Baseline: End of Treatment | 28.0 ± 16.97 | 28.5 ± 36.06 | -6.5 ± 37.48 | 15.0 ± 11.31 |
| QT interval: Change from Baseline: Follow Up 1 | 28.5 ± 26.16 | 2.0 ± NA | -12.0 ± 15.56 | -8.5 ± 2.12 |
| QT interval: Change from Baseline: Follow Up 2 | 38.0 ± NA | -13.0 ± NA | -23.0 ± NA | 38.0 ± NA |
| QTcF: Baseline | 395.0 ± 28.28 | 423.0 ± 41.01 | 408.0 ± 1.41 | 411.5 ± 10.61 |
| QTcF: Change from Baseline: Day 1 - 30 minutes | -1.0 ± 19.80 | — | -10.0 ± 14.14 | — |
| QTcF: Change from Baseline: Day 1 - 2 hours | -2.0 ± 2.83 | — | -8.5 ± 9.19 | — |
| QTcF: Change from Baseline: Day 1 - 6 hours | 7.0 ± 16.97 | -10.5 ± 23.33 | -9.5 ± 21.92 | -1.0 ± 7.07 |
| QTcF: Change from Baseline: Day 1 - 12 hours | 17.5 ± 12.02 | 5.0 ± 7.07 | 9.5 ± 17.68 | -6.0 ± 9.90 |
| QTcF: Change from Baseline: End of Treatment | 18.5 ± 7.78 | 9.0 ± 14.14 | 0.5 ± 16.26 | 6.5 ± 6.36 |
| QTcF: Change from Baseline: Follow Up 1 | 16.0 ± 8.49 | 1.0 ± NA | -19.0 ± 15.56 | 6.0 ± 9.90 |
| QTcF: Change from Baseline: Follow Up 2 | 18.0 ± NA | -12.0 ± NA | -21.0 ± NA | 24.0 ± NA |
The average of the triplicate readings collected at each assessment time was calculated for each ECG parameter. Baseline was defined as the average (if possible) of the triplicate pre-dose recordings on Day 1. Only centrally read ECG data was used.
| Millisecond | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|
| PR interval: Baseline | 145.7 ± 12.86 | 139.7 ± 19.14 | 156.0 ± 28.31 |
| PR interval: Change from Baseline: Day 2 | 3.8 ± 14.76 | -5.0 ± 15.17 | 1.3 ± 4.51 |
| PR interval: Change from Baseline: Day 3 | 1.2 ± 17.88 | -3.2 ± 9.91 | 6.0 ± 11.36 |
| PR interval: Change from Baseline: Day 5 | 5.7 ± 19.81 | -1.6 ± 13.50 | -3.0 ± 14.14 |
| PR interval: Change from Baseline: End of Treatment | 9.3 ± 15.46 | -0.6 ± 15.82 | -0.3 ± 7.64 |
| PR interval: Change from Baseline: Early Termination | — | — | -1.0 ± NA |
| PR interval: Change from Baseline: Follow Up 1 | 7.2 ± 18.63 | 1.4 ± 17.86 | -8.0 ± 18.36 |
| PR interval: Change from Baseline: Follow Up 2 | 6.8 ± 28.85 | -30.0 ± NA | -6.0 ± NA |
| PR interval: Change from Baseline: Follow Up 3 | 12.0 ± 24.45 | -21.0 ± 31.11 | -18.0 ± NA |
| PR interval: Change from Baseline: Follow Up 4 | 15.0 ± NA | -4.0 ± 19.31 | -23.0 ± NA |
| QRS interval: Baseline | 93.7 ± 4.68 | 93.6 ± 10.63 | 90.5 ± 4.43 |
| QRS interval: Change from Baseline: Day 2 | 6.7 ± 7.94 | 1.7 ± 5.09 | 4.7 ± 7.09 |
| QRS interval: Change from Baseline: Day 3 | -0.7 ± 3.08 | 3.5 ± 5.32 | 3.3 ± 3.30 |
| QRS interval: Change from Baseline: Day 5 | 0.7 ± 2.88 | 3.0 ± 3.92 | 7.0 ± 5.29 |
| QRS interval: Change from Baseline: End of Treatment | 0.3 ± 3.78 | 5.6 ± 5.56 | 2.3 ± 3.51 |
| QRS interval: Change from Baseline: Early Termination | — | — | -3.0 ± NA |
| QRS interval: Change from Baseline: Follow Up 1 | 1.0 ± 4.18 | 4.0 ± 6.43 | 2.3 ± 6.35 |
| QRS interval: Change from Baseline: Follow Up 2 | 2.3 ± 4.50 | 16.0 ± NA | 8.0 ± NA |
| QRS interval: Change from Baseline: Follow Up 3 | -0.3 ± 4.86 | 6.0 ± 5.66 | 15.0 ± NA |
| QRS interval: Change from Baseline: Follow Up 4 | -12.0 ± NA | 7.0 ± 3.61 | 5.0 ± NA |
| QT interval: Baseline | 385.5 ± 24.74 | 366.1 ± 22.17 | 373.8 ± 59.57 |
| QT interval: Change from Baseline: Day 2 | 25.3 ± 35.59 | 16.2 ± 48.16 | 8.3 ± 9.07 |
| QT interval: Change from Baseline: Day 3 | 27.5 ± 59.06 | 27.3 ± 43.01 | 10.0 ± 37.34 |
| QT interval: Change from Baseline: Day 5 | 12.5 ± 31.04 | 29.0 ± 21.57 | 28.0 ± 61.54 |
| QT interval: Change from Baseline: End of Treatment | 21.8 ± 46.10 | 23.3 ± 31.07 | 8.0 ± 60.61 |
| QT interval: Change from Baseline: Early Termination | — | — | -17.0 ± NA |
| QT interval: Change from Baseline: Follow Up 1 | -10.2 ± 39.09 | 20.9 ± 16.82 | -49.7 ± 32.59 |
| QT interval: Change from Baseline: Follow Up 2 | -19.3 ± 27.00 | 63.0 ± NA | 0.0 ± NA |
| QT interval: Change from Baseline: Follow Up 3 | -22.0 ± 22.17 | 24.5 ± 13.44 | -21.0 ± NA |
| QT interval: Change from Baseline: Follow Up 4 | 5.0 ± NA | -4.0 ± 39.36 | -36.0 ± NA |
| QTcF: Baseline | 404.7 ± 18.13 | 401.3 ± 10.44 | 405.3 ± 18.84 |
| QTcF: Change from Baseline: Day 2 | 17.5 ± 20.96 | 6.8 ± 19.75 | 9.0 ± 7.94 |
| QTcF: Change from Baseline: Day 3 | 8.3 ± 27.66 | 8.0 ± 21.80 | 7.5 ± 24.19 |
| QTcF: Change from Baseline: Day 5 | -0.2 ± 11.82 | 16.4 ± 20.74 | 19.7 ± 39.37 |
| QTcF: Change from Baseline: End of Treatment | 3.7 ± 16.50 | 10.7 ± 17.93 | -1.3 ± 15.50 |
| QTcF: Change from Baseline: Early Termination | — | — | -1.0 ± NA |
| QTcF: Change from Baseline: Follow Up 1 | -7.2 ± 9.09 | 9.1 ± 18.43 | -15.7 ± 23.01 |
| QTcF: Change from Baseline: Follow Up 2 | -5.8 ± 9.00 | 18.0 ± NA | 9.0 ± NA |
| QTcF: Change from Baseline: Follow Up 3 | -7.3 ± 9.54 | 4.5 ± 13.44 | -7.0 ± NA |
| QTcF: Change from Baseline: Follow Up 4 | -6.0 ± NA | 2.3 ± 19.43 | 7.0 ± NA |
C24 was defined as concentration at 24 hours. 24-hour PK draw was approximately 4 hours post end of infusion which corresponded to 28 hours.
| ng/mL | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion |
|---|---|---|
| C24 of PF-07304814 | NA ± NA | NA ± NA |
| C24 of PF-00835231 | NA ± NA | NA ± NA |
C120 was defined as concentration at 120 hours. Blood sample collection at approximately at 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.
| ng/mL | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion |
|---|---|---|
| C120 of PF-07304814 | 197.2 ± 72 | 91.64 ± 51 |
| C120 of PF-00835231 | 1338 ± 84 | 800.8 ± 19 |
Cmax was defined as maximum observed concentration. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.
| ng/mL | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion |
|---|---|---|
| Cmax of PF-07304814 | 345.3 ± 70 | 272.6 ± 281 |
| Cmax of PF-00835231 | 2382 ± 36 | 1265 ± 20 |
t½ was defined as terminal half-life. Blood sample collection at approximately within 30 minutes before end of infusion (\~120 hours), and at 2 and 6 hours post the end of the infusion, which correspond to approximately 122h and 126h post the start of infusion.
| hour | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion |
|---|---|---|
| t½ of PF-00835231 | 1.79 ± NA | 2.317 ± 0.96547 |
Css was defined as concentration at steady state. Blood sample collection at approximately 2 and 6 hours post the end of the infusion, which correspond to approximately 122 hours and 126 hours post the start of infusion.
| ng/mL | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion |
|---|---|---|
| Css of PF-07304814 | 229.2 ± 61 | 102.2 ± 35 |
| Css of PF-00835231 | 1720 ± 44 | 970.2 ± 16 |
Collected over From pre-dose on Day 1 up to 41 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | 0/2 (0%) | 1/2 (50%) | 1/2 (50%) |
| Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | 0/2 (0%) | 0/2 (0%) | 1/2 (50%) |
| Part 1: 500 mg Placebo 24-hours Continuous Infusion | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Part 1: 250 mg Placebo 24-hours Continuous Infusion | 0/2 (0%) | 1/2 (50%) | 2/2 (100%) |
| Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | 0/6 (0%) | 1/6 (16.7%) | 2/6 (33.3%) |
| Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | 0/7 (0%) | 2/7 (28.6%) | 3/7 (42.9%) |
| Part 2: Placebo 120-hours Continuous Infusion | 1/4 (25%) | 1/4 (25%) | 3/4 (75%) |
| Event | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|---|---|---|---|
| COVID-19 pneumoniaInfections and infestations | 0/2 | 0/2 | 0/2 | 1/2 | 0/6 | 0/7 | 0/4 |
| Subclavian vein thrombosisVascular disorders | 1/2 | 0/2 | 1/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/6 | 0/7 | 1/4 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/2 | 0/2 | 0/2 | 0/2 | 1/6 | 0/7 | 1/4 |
| PneumoniaInfections and infestations | 0/2 | 0/2 | 0/2 | 0/2 | 0/6 | 1/7 | 0/4 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/6 | 1/7 | 0/4 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/2 | 0/2 | 0/2 | 0/2 | 0/6 | 1/7 | 0/4 |
| Event | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion |
|---|---|---|---|---|---|---|---|
| CoagulopathyBlood and lymphatic system disorders | 0/2 | 1/2 | 0/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| TachycardiaCardiac disorders | 0/2 | 0/2 | 1/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| Abdominal painGastrointestinal disorders | 0/2 | 0/2 | 1/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| DiarrhoeaGastrointestinal disorders | 1/2 | 0/2 | 1/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| DyspepsiaGastrointestinal disorders | 0/2 | 0/2 | 0/2 | 1/2 | 0/6 | 0/7 | 0/4 |
| OedemaGeneral disorders | 0/2 | 0/2 | 0/2 | 1/2 | 0/6 | 0/7 | 0/4 |
| FolliculitisInfections and infestations | 1/2 | 0/2 | 0/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| Tinea crurisInfections and infestations | 0/2 | 0/2 | 1/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| Haematocrit decreasedInvestigations | 0/2 | 0/2 | 1/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| Haemoglobin decreasedInvestigations | 0/2 | 0/2 | 1/2 | 0/2 | 0/6 | 0/7 | 0/4 |
| Age, Categorical(Participants) | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion | Total |
|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 2 | 2 | 1 | 5 | 5 | 2 | 18 |
| >=65 years | 1 | 0 | 0 | 1 | 1 | 2 | 2 | 7 |
| Sex: Female, Male(Participants) | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 1 | 0 | 1 | 1 | 2 | 1 | 0 | 6 |
| Male | 1 | 2 | 1 | 1 | 4 | 6 | 4 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 0 | 1 | 0 | 2 | 0 | 0 | 4 |
| Not Hispanic or Latino | 1 | 2 | 1 | 2 | 4 | 5 | 3 | 18 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Part 1: PF-07304814 500 mg 24-hours Continuous Infusion | Part 1: PF-07304814 250 mg 24-hours Continuous Infusion | Part 1: 500 mg Placebo 24-hours Continuous Infusion | Part 1: 250 mg Placebo 24-hours Continuous Infusion | Part 2: PF-07304814 500 mg 120-hours Continuous Infusion | Part 2: PF-07304814 250 mg 120-hours Continuous Infusion | Part 2: Placebo 120-hours Continuous Infusion | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 2 |
| White | 2 | 1 | 1 | 2 | 5 | 5 | 3 | 19 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 3 |
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Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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