A Phase 2 interventional study of Belnacasan and Placebo in COVID-19, sponsored by MedStar Health. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by MedStar Health · Phase 2, Interventional, and Treatment
The purpose of this trial is to assess the safety, tolerability and treatment effect of the orally administered Caspase-1 inhibitor, belnacasan, for the treatment of patients with mild to moderate COVID-19 and to generate proof of concept for future trials.
COVID-19 is an acute respiratory disease caused by the SARS-CoV-2 virus which has impacted the lives of millions of patients. Though vaccines and preventive treatments such as monoclonal antibodies, steroids, and anti-virals have been established, they do not specifically target the resulting inflammatory response and complications the virus causes.
This study aims to evaluate how safe and effective a particular oral medication, Belnacasan, is in diminishing your body's inflammatory response, which may go into overdrive when infected with the virus. This overly activated immune response can become uncontrolled resulting in cell death and the release of damaging proteins which can cause major harm to all organs throughout the body.
Belnacasan prevents the activation of a particular enzyme, Caspase-1, which plays a major role in activating this damaging immune response brought on by COVID-19. The goal of this medication being a more targeted treatment that aims to prevent the devastating immune response.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →This is the only study on the registry with MedStar Health as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subject is male or non-pregnant female adult ≥18 years of age at time of consent
a. Women with a history of menstruation must agree to use two methods of contraception, at least one of which is highly effective, for the duration of the study as well as to undergo additional pregnancy testing during the study
Subject has evidence of either mild or moderate COVID-19 illness of less than 7 days from first onset, with minimal baseline symptom severity based on patient-reported FDA scoring system defined as follows:
Exclusion Criteria:
History of any pre-existing organ impairment, such as:
While dosed with IP, the taking of prohibited concomitant medication or the ingestion of food that interferes with the IP, including:
900mg dose TID Administration Total: 2700mg
Drug: Belnacasan
0 mg dose TID Administration Total: 0 mg
Drug: Placebo
Oral administration
Tablet containing 0mg of API
Safety and Tolerability of Belnacasan
Number of adverse events and serious adverse events
Time frame: Through 60 days post enrollment
Sustained Recovery and Resolution Rates of Common COVID-19 Symptoms
Proportion of subjects in treatment group versus placebo group, respectively, who, per symptom questionnaire, rate stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath at rest, shortness of breath with exertion, or impairment in sense of smell or taste as mild, moderate or severe.
Time frame: Baseline and Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization
Sustained Improvement of Global Impression Rates
Proportion of subjects in treatment group versus placebo group, respectively, who per symptom questionnaire have answered for two consecutive days: "YES" to "In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)?"; "YES" to "In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?"
Time frame: Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization
Time to Sustained Recovery or Resolution of Common COVID-19 Symptoms
Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained recovery and resolution rates of common COVID-19 symptoms.
Time frame: Over 60 days post randomization
Time to Sustained Improvement of Global Impression
Comparison in treatment group versus placebo group, respectively, of the mean number of days from randomization to the first day of achieving sustained improvement of global impression rates.
Time frame: Over 60 days post randomization
Rates of Fever
Proportion of subjects in treatment group versus placebo group, respectively, who, per thermometer, experienced fever at any point between enrollment and day 2 post randomization.
Time frame: Days between enrollment and day 2 post randomization
Oxygenation Levels
Average change from baseline over 60 days in percentage of blood saturation
Time frame: Over 60 days post randomization
Time in Days to Normalization of Fever and Oxygenation Levels.
Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained (i.e., at least 2 days) resolution of fever for subjects who presented with fever at any point between enrollment and day 2 post randomization; with temperature \<38C or \>=38C experienced in total during the first 28 days post randomization; from randomization to the first day post randomization of achieving oxygenation of SpO2\>=96% in room air when resting for subjects who presented with SpO2\>93% and \<96% in room air, when resting, at enrollment; with oxygenation of SpO2\>= 96% or SpO2\>93% in room air, when resting, in total during the first 28 days post randomization.
Time frame: 28 Days
Experiences of COVID-19 Related Deterioration and Mortality
Proportion of treatment group, versus placebo group, respectively, who per subject reporting or medical records had experienced an emergency department visit, other than at study enrollment or study visits; hospitalization for COVID-19; hospitalization for COVID-19 requiring oxygen; hospitalization for COVID-19 requiring ICU; hospitalization for COVID-19 requiring ventilation; COVID-19 related death; death; hospitalization or death on Days 14, 28, and 60.
Time frame: Days 14, 28 and 60 post randomization
The Number of Subjects With COVID-19 Related Deterioration and Mortality Experiences
Comparison of treatment group versus placebo group, respectively, in the number of subjects who following randomization experienced hospitalization for COVID-19 related deterioration: requiring oxygen, requiring ICU admission, requiring ventilation.
Time frame: Over 28 days
Changes on the WHO 9-Point Ordinal Scale
The counts of participants in the treatment group versus placebo group, respectively, who per questionnaire on WHO 9-point ordinal scale \[0: Uninfected or "no clinical or virological evidence of infection"; 1: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities; 3: Hospitalized, not requiring supplemental oxygen; 4: Hospitalized, requiring supplemental oxygen; 5: Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6: Hospitalized, intubated; 7: Hospitalized, advanced life support including invasive mechanical ventilation or ECMO; 8: Death\] had experienced an improvement from scale 2 to scale 1 or 0; an improvement from scale 1 to scale 0 ; a sustainment from scale 1 to scale 1; any improvement of the scale; any worsening of the scale; scale 4 or higher; scale 6 or higher.
Time frame: Days 4, 7, 10, 14, 21, 28, 42, and 60 post randomization
Values on the WHO 9-Point Ordinal Scale
Comparison of treatment group versus placebo group, respectively, in the average of daily scale value (0-8) on Days 14, 28, and 60 with respect to the number of subjects who reported as uninfected (scale value of 0), had no limitations (scale value of 1), or were experiencing limitations (scale value of 2). All patients had a score ranging between 0-2. A description of the WHO 9-Point Ordinal Scale follows: 0. Uninfected or "no clinical or virological evidence of infection" * defined as subject answering "Yes" to "In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)?" 1. Not hospitalized, no limitations on activities * defined as subject answering "Yes" to "In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?" 2. Not hospitalized, limitation on activities * defined as subject answering "No" to "In the past 24 hours, have you returned to your usual act
Time frame: Days 14, 28, and 60 post randomization
Time to Improvement on the WHO 9-Point Ordinal Scale
Comparison of treatment group versus placebo group, respectively, in the mean number of days from enrollment to reporting "no limitations" or "uninfected". The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data.
Time frame: Post treatment to Day 60
Mean Number of Days of Experiencing WHO 9-Point Ordinal Scale Values
Comparison of treatment group versus placebo group, respectively, in the mean number of days on which subjects experienced "limitations", "no limitations", and "uninfected" post treatment (60 Days).
Time frame: Post treatment through Day 60
IL-6
Plasma levels of IL-6
Time frame: Baseline and Days 7, 14, 21, 28
IL-1ra
Measurement of plasma IL-1ra levels
Time frame: Baseline and Days 7, 14, 21, 28
IL-18
Measurement of plasma levels of IL-18
Time frame: Baseline and Days 7, 14, 21, and 28
TNF-alpha
Plasma levels of TNF-alpha
Time frame: Baseline and Days 7, 14, 21, and 28
Caspase-1
Plasma levels of caspase-1
Time frame: Baseline and Days 7, 14, 21, and 28
Gasdermin D
Plasma levels of gasdermin D
Time frame: Baseline and Days 7, 14, 21, and 28
G-CSF
Plasma levels of G-CSF
Time frame: Baseline and Days 7, 14, 21, and 28
| Milestone | Interventional | Placebo |
|---|---|---|
| Started | 20 | 20 |
| Completed | 18 | 18 |
| Not completed | 2 | 2 |
Number of adverse events and serious adverse events
| Number of AEs and SAEs | Interventional | Placebo |
|---|---|---|
| Number of adverse events | 11 | 10 |
| Number of serious adverse events | 0 | 0 |
Proportion of subjects in treatment group versus placebo group, respectively, who, per symptom questionnaire, rate stuffy or runny nose, sore throat, cough, low energy or tiredness, muscle or body ache, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea, shortness of breath at rest, shortness of breath with exertion, or impairment in sense of smell or taste as mild, moderate or severe.
| Participants | Interventional | Placebo |
|---|---|---|
| Runny/stuffy nose at Baseline | 14 | 19 |
| Runny/stuffy nose at Day 4 | 13 | 13 |
| Runny/stuffy nose at Day 7 | 17 | 17 |
| Runny/stuffy nose at Day 10 | 6 | 4 |
| Runny/stuffy nose at Day 14 | 12 | 10 |
| Runny/stuffy nose at Day 21 | 5 | 3 |
| Runny/stuffy nose at Day 28 | 5 | 1 |
| Runny/stuffy nose at Day 42 | 1 | 0 |
| Runny/stuffy nose at Day 60 | 1 | 0 |
| Sore throat at Baseline | 13 | 14 |
| Sore throat at Day 4 | 4 | 3 |
| Sore throat at Day 7 | 14 | 9 |
| Sore throat at Day 10 | 1 | 0 |
| Sore throat at Day 14 | 4 | 2 |
| Sore throat at Day 21 | 0 | 0 |
| Sore throat at Day 28 | 1 | 0 |
| Sore throat at Day 42 | 0 | 0 |
| Sore throat at Day 60 | 0 | 0 |
| Cough at Baseline | 17 | 18 |
| Cough at Day 4 | 13 | 12 |
| Cough at Day 7 | 16 | 18 |
| Cough at Day 10 | 7 | 9 |
| Cough at Day 14 | 11 | 15 |
| Cough at Day 21 | 7 | 6 |
| Cough at Day 28 | 6 | 3 |
| Cough at Day 42 | 1 | 0 |
| Cough at Day 60 | 1 | 0 |
| Low energy or tiredness at Baseline | 17 | 14 |
| Low energy or tiredness at Day 4 | 10 | 7 |
| Low energy or tiredness at Day 7 | 18 | 17 |
| Low energy or tiredness at Day 10 | 6 | 1 |
| Low energy or tiredness at Day 14 | 11 | 4 |
| Low energy or tiredness at Day 21 | 6 | 3 |
| Low energy or tiredness at Day 28 | 7 | 1 |
| Low energy or tiredness at Day 42 | 1 | 0 |
| Low energy or tiredness at Day 60 | 0 | 0 |
| Muscle or body aches at Baseline | 13 | 11 |
| Muscle or body aches at Day 4 | 7 | 1 |
| Muscle or body aches at Day 7 | 13 | 13 |
| Muscle or body aches at Day 10 | 2 | 0 |
| Muscle or body aches at Day 14 | 6 | 1 |
| Muscle or body aches at Day 21 | 3 | 2 |
| Muscle or body aches at Day 28 | 3 | 0 |
| Muscle or body aches at Day 42 | 1 | 0 |
| Muscle or body aches at Day 60 | 0 | 0 |
| Headache at Baseline | 10 | 12 |
| Headache at Day 4 | 5 | 2 |
| Headache at Day 7 | 15 | 11 |
| Headache at Day 10 | 4 | 1 |
| Headache at Day 14 | 5 | 5 |
| Headache at Day 21 | 3 | 1 |
| Headache at Day 28 | 5 | 2 |
| Headache at Day 42 | 2 | 0 |
| Headache at Day 60 | 0 | 0 |
| Chills or shivering at Baseline | 7 | 4 |
| Chills or shivering at Day 4 | 1 | 1 |
| Chills or shivering at Day 7 | 6 | 7 |
| Chills or shivering at Day 10 | 0 | 0 |
| Chills or shivering at Day | 1 | 1 |
| Chills or shivering at Day 21 | 1 | 0 |
| Chills or shivering at Day 28 | 2 | 0 |
| Chills or shivering at Day 42 | 0 | 0 |
| Chills or shivering at Day 60 | 0 | 0 |
| Feeling hot or feverish at Baseline | 8 | 8 |
| Feeling hot or feverish at Day 4 | 3 | 0 |
| Feeling hot or feverish at Day 7 | 10 | 10 |
| Feeling hot or feverish at Day 10 | 0 | 0 |
| Feeling hot or feverish at Day 14 | 1 | 1 |
| Feeling hot or feverish at Day 21 | 0 | 0 |
| Feeling hot or feverish at Day 28 | 1 | 0 |
| Feeling hot or feverish at Day 42 | 0 | 0 |
| Feeling hot or feverish at Day 60 | 0 | 0 |
| Nausea at Baseline | 6 | 1 |
| Nausea at Day 4 | 2 | 1 |
| Nausea at Day 7 | 7 | 3 |
| Nausea at Day 10 | 2 | 0 |
| Nausea at Day 14 | 3 | 1 |
| Nausea at Day 21 | 0 | 2 |
| Nausea at Day 28 | 2 | 0 |
| Nausea at Day 42 | 0 | 0 |
| Nausea at Day 60 | 0 | 0 |
| Vomiting at Baseline | 0 | 0 |
| Vomiting at Day 4 | 0 | 0 |
| Vomiting at Day 7 | 0 | 0 |
| Vomiting at Day 10 | 0 | 0 |
| Vomiting at Day 14 | 0 | 0 |
| Vomiting at Day 21 | 0 | 0 |
| Vomiting at Day 28 | 0 | 0 |
| Vomiting at Day 42 | 0 | 0 |
| Vomiting at Day 60 | 0 | 0 |
| Diarrhea at Baseline | 3 | 1 |
| Diarrhea at Day 4 | 6 | 4 |
| Diarrhea at Day 7 | 10 | 6 |
| Diarrhea at Day 10 | 3 | 0 |
| Diarrhea at Day 14 | 7 | 3 |
| Diarrhea at Day 21 | 4 | 3 |
| Diarrhea at Day 28 | 5 | 2 |
| Diarrhea at Day 42 | 0 | 0 |
| Diarrhea at Day 60 | 0 | 0 |
| Shortness of breath at rest at Baseline | 6 | 1 |
| Shortness of breath at rest at Day 4 | 4 | 2 |
| Shortness of breath at rest at Day 7 | 0 | 0 |
| Shortness of breath at rest at Day 10 | 2 | 0 |
| Shortness of breath at rest at Day 14 | 4 | 1 |
| Shortness of breath at rest at Day 21 | 2 | 0 |
| Shortness of breath at rest at Day 28 | 2 | 0 |
| Shortness of breath at rest at Day 42 | 0 | 0 |
| Shortness of breath at rest at Day 60 | 0 | 0 |
| Shortness of breath with exertion at Baseline | 7 | 5 |
| Shortness of breath with exertion at Day 4 | 5 | 4 |
| Shortness of breath with exertion at Day 7 | 14 | 10 |
| Shortness of breath with exertion at Day 10 | 5 | 3 |
| Shortness of breath with exertion at Day 14 | 8 | 2 |
| Shortness of breath with exertion at Day 21 | 4 | 2 |
| Shortness of breath with exertion at Day 28 | 2 | 1 |
| 1Shortness of breath with exertion at Day 42 | 1 | 1 |
| Shortness of breath with exertion at Day 60 | 0 | 1 |
| Impairment of sense of smell at Baseline | 4 | 3 |
| Impairment of sense of smell at Day 4 | 4 | 3 |
| Impairment of sense of smell at Day 7 | 5 | 5 |
| Impairment of sense of smell at Day 10 | 1 | 1 |
| Impairment of sense of smell at Day 14 | 1 | 2 |
| Impairment of sense of smell at Day 21 | 1 | 1 |
| Impairment of sense of smell at Day 28 | 0 | 0 |
| Impairment of sense of smell at Day 42 | 0 | 0 |
| Impairment of sense of smell at Day 60 | 0 | 0 |
| Impairment of sense of taste at Baseline | 6 | 6 |
| Impairment of sense of taste at Day 4 | 5 | 5 |
| Impairment of sense of taste at Day 7 | 6 | 6 |
| Impairment of sense of taste at Day 10 | 2 | 1 |
| Impairment of sense of taste at Day 14 | 1 | 2 |
| Impairment of sense of taste at Day 21 | 0 | 0 |
| Impairment of sense of taste at Day 28 | 0 | 0 |
| Impairment of sense of taste at Day 42 | 0 | 0 |
| Impairment of sense of taste at Day 60 | 0 | 0 |
Proportion of subjects in treatment group versus placebo group, respectively, who per symptom questionnaire have answered for two consecutive days: "YES" to "In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)?"; "YES" to "In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?"
| Participants | Interventional | Placebo |
|---|---|---|
| Day 4 "Returned to usual health" | 0 | 0 |
| Day 7 "Returned to usual health" | 5 | 5 |
| Day 10 "Returned to usual health" | 5 | 6 |
| Day 14 "Returned to usual health" | 11 | 12 |
| Day 21 "Returned to usual health" | 11 | 16 |
| Day 28 "Returned to usual health" | 12 | 12 |
| Day 42 "Returned to usual health" | 16 | 16 |
| Day 60 "Returned to usual health" | 16 | 15 |
| Day 4 "Returned to usual activity" | 0 | 4 |
| Day 7 "Returned to usual activity" | 9 | 9 |
| Day 10 "Returned to usual activity" | 11 | 15 |
| Day 14 "Returned to usual activity" | 15 | 17 |
| Day 21 "Returned to usual activity" | 15 | 17 |
| Day 28 "Returned to usual activity" | 14 | 13 |
| Day 42 "Returned to usual activity" | 16 | 17 |
| Day 60 "Returned to usual activity" | 17 | 15 |
Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained recovery and resolution rates of common COVID-19 symptoms.
| Days | Interventional | Placebo |
|---|---|---|
| Time to Sustained Recovery or Resolution of Common COVID-19 Symptoms | 20.6 ± 18.1 | 15.4 ± 7.8 |
Comparison in treatment group versus placebo group, respectively, of the mean number of days from randomization to the first day of achieving sustained improvement of global impression rates.
| Days | Interventional | Placebo |
|---|---|---|
| Time to Sustained Improvement of Global Impression | 10.5 ± 1.5 | 13.5 ± 2.9 |
Proportion of subjects in treatment group versus placebo group, respectively, who, per thermometer, experienced fever at any point between enrollment and day 2 post randomization.
| Participants | Interventional | Placebo |
|---|---|---|
| Rates of Fever | 1 | 0 |
Average change from baseline over 60 days in percentage of blood saturation
| percentage of blood saturation | Interventional | Placebo |
|---|---|---|
| Oxygenation Levels | -0.01 (-0.01 to 0.00) | -0.01 (-0.02 to 0.01) |
Comparison in treatment group versus placebo group, respectively, of the number of days from randomization to the first day of achieving sustained (i.e., at least 2 days) resolution of fever for subjects who presented with fever at any point between enrollment and day 2 post randomization; with temperature \<38C or \>=38C experienced in total during the first 28 days post randomization; from randomization to the first day post randomization of achieving oxygenation of SpO2\>=96% in room air when resting for subjects who presented with SpO2\>93% and \<96% in room air, when resting, at enrollment; with oxygenation of SpO2\>= 96% or SpO2\>93% in room air, when resting, in total during the first 28 days post randomization.
| Days | Interventional | Placebo |
|---|---|---|
| Time in days to normalization of fever | 4 ± 0.00 | — |
| Time in days to normalization of oxygenation level | — | 7 ± 0.00 |
Proportion of treatment group, versus placebo group, respectively, who per subject reporting or medical records had experienced an emergency department visit, other than at study enrollment or study visits; hospitalization for COVID-19; hospitalization for COVID-19 requiring oxygen; hospitalization for COVID-19 requiring ICU; hospitalization for COVID-19 requiring ventilation; COVID-19 related death; death; hospitalization or death on Days 14, 28, and 60.
| Number of subjects | Interventional | Placebo |
|---|---|---|
| Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 14. | 0 | 0 |
| Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 28 | 0 | 0 |
| Subjects who had COVID-related: ER visit, hospitalization, ICU visit, or died by Day 60 | 0 | 0 |
| Subjects who required oxygen or ventilation by Day 14 | 0 | 0 |
| Subjects who required oxygen or ventilation by Day 28 | 0 | 0 |
| Subjects who required oxygen or ventilation by Day 60 | 0 | 0 |
Comparison of treatment group versus placebo group, respectively, in the number of subjects who following randomization experienced hospitalization for COVID-19 related deterioration: requiring oxygen, requiring ICU admission, requiring ventilation.
| participants | Interventional | Placebo |
|---|---|---|
| The Number of Subjects With COVID-19 Related Deterioration and Mortality Experiences | 0 | 0 |
The counts of participants in the treatment group versus placebo group, respectively, who per questionnaire on WHO 9-point ordinal scale \[0: Uninfected or "no clinical or virological evidence of infection"; 1: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities; 3: Hospitalized, not requiring supplemental oxygen; 4: Hospitalized, requiring supplemental oxygen; 5: Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6: Hospitalized, intubated; 7: Hospitalized, advanced life support including invasive mechanical ventilation or ECMO; 8: Death\] had experienced an improvement from scale 2 to scale 1 or 0; an improvement from scale 1 to scale 0 ; a sustainment from scale 1 to scale 1; any improvement of the scale; any worsening of the scale; scale 4 or higher; scale 6 or higher.
| Participants | Interventional | Placebo |
|---|---|---|
| Day 4 | 3 | 6 |
| Day 7 | 8 | 8 |
| Day 10 | 14 | 13 |
| Day 14 | 14 | 11 |
| Day 21 | 15 | 15 |
| Day 28 | 16 | 16 |
| Day 42 | 16 | 16 |
| Day 60 | 17 | 15 |
Comparison of treatment group versus placebo group, respectively, in the average of daily scale value (0-8) on Days 14, 28, and 60 with respect to the number of subjects who reported as uninfected (scale value of 0), had no limitations (scale value of 1), or were experiencing limitations (scale value of 2). All patients had a score ranging between 0-2. A description of the WHO 9-Point Ordinal Scale follows: 0. Uninfected or "no clinical or virological evidence of infection" * defined as subject answering "Yes" to "In the past 24 hours, have you returned to your usual health (before your COVID-19 illness)?" 1. Not hospitalized, no limitations on activities * defined as subject answering "Yes" to "In the past 24 hours, have you returned to your usual activities (before your COVID-19 illness)?" 2. Not hospitalized, limitation on activities * defined as subject answering "No" to "In the past 24 hours, have you returned to your usual act
| units on a scale | Interventional | Placebo |
|---|---|---|
| Average WHO-9 point scale value at Day 14 | 1.00 ± 0.69 | 0.94 ± 0.87 |
| Average WHO-9 point scale value at Day 28 | 0.33 ± 0.69 | 0.17 ± 0.51 |
| Average WHO-9 point scale value at Day 60 | 0.00 ± 0.00 | 0.12 ± 0.48 |
Comparison of treatment group versus placebo group, respectively, in the mean number of days from enrollment to reporting "no limitations" or "uninfected". The discrepancy in patient numbers (enrolled versus analyzed) is due to patients who either dropped out or have missing data.
| Days | Interventional | Placebo |
|---|---|---|
| Days to "no limitations" | 9.3 ± 6.1 | 7.1 ± 5.0 |
| Days to "uninfected" | 27.2 ± 14.3 | 19.0 ± 8.9 |
Comparison of treatment group versus placebo group, respectively, in the mean number of days on which subjects experienced "limitations", "no limitations", and "uninfected" post treatment (60 Days).
| Days | Interventional | Placebo |
|---|---|---|
| Limitations | 2.9 ± 1.8 | 2.8 ± 1.7 |
| No limitations | 2.2 ± 1.9 | 1.7 ± 1.4 |
| Uninfected | 3.0 ± 1.7 | 3.8 ± 2.1 |
Plasma levels of IL-6
| pg/mL | Interventional | Placebo |
|---|---|---|
| Baseline | 17.4 ± 13.6 | 14.6 ± 10.0 |
| Day 7 | 15.1 ± 12.1 | 11.1 ± 8.4 |
| Day 14 | 16.9 ± 13.4 | 9.7 ± 2.7 |
| Day 21 | 16.0 ± 15.1 | 10.2 ± 2.1 |
| Day 28 | 13.9 ± 10.8 | 9.7 ± 3.7 |
Measurement of plasma IL-1ra levels
| pg/mL | Interventional | Placebo |
|---|---|---|
| Baseline | 37.2 ± 19.0 | 32.5 ± 14.4 |
| Day 7 | 31.2 ± 18.1 | 26.6 ± 11.4 |
| Day 14 | 34.0 ± 13.6 | 23.2 ± 7.7 |
| Day 21 | 40.2 ± 14.5 | 23.7 ± 11.2 |
| Day 28 | 37.1 ± 15.8 | 25.4 ± 7.6 |
Measurement of plasma levels of IL-18
| pg/mL | Interventional | Placebo |
|---|---|---|
| Baseline | 120.1 ± 69.6 | 116.0 ± 65.9 |
| Day 7 | 82.0 ± 60.4 | 88.6 ± 47.6 |
| Day 14 | 77.0 ± 58.8 | 81.7 ± 38.6 |
| Day 21 | 75.1 ± 58.9 | 80.7 ± 43.6 |
| Day 28 | 73.7 ± 56.0 | 74.4 ± 36.6 |
Plasma levels of TNF-alpha
| pg/mL | Interventional | Placebo |
|---|---|---|
| Baseline | 131.1 ± 99.9 | 97.0 ± 46.8 |
| Day 7 | 124.5 ± 104.2 | 97.8 ± 38.9 |
| Day 14 | 137.1 ± 123.7 | 97.8 ± 51.4 |
| Day 21 | 121.4 ± 112.6 | 84.0 ± 46.5 |
| Day 28 | 128.4 ± 140.8 | 89.9 ± 42.3 |
Plasma levels of caspase-1
| pg/mL | Interventional | Placebo |
|---|---|---|
| Baseline | 97.2 ± 77.6 | 115.5 ± 110 |
| Day 7 | 84.7 ± 95.2 | 104.4 ± 92.0 |
| Day 14 | 69.5 ± 74.8 | 96.4 ± 105.8 |
| Day 21 | 98.7 ± 120.0 | 96.4 ± 105.8 |
| Day 28 | 101.6 ± 150.9 | 83.4 ± 66.4 |
Plasma levels of gasdermin D
| pg/mL | Interventional | Placebo |
|---|---|---|
| Baseline | 2.5 ± 1.9 | 3.5 ± 2.9 |
| Day 7 | 4.0 ± 2.5 | 4.9 ± 4.0 |
| Day 14 | 5.0 ± 3.1 | 5.2 ± 3.6 |
| Day 21 | 6.2 ± 3.1 | 7.2 ± 4.0 |
| Day 28 | 5.4 ± 3.3 | 5.4 ± 2.7 |
Plasma levels of G-CSF
| pg/mL | Interventional | Placebo |
|---|---|---|
| Baseline | 137.2 ± 34.2 | 147.0 ± 56.9 |
| Day 7 | 125.0 ± 29.1 | 106.6 ± 36.4 |
| Day 14 | 121.4 ± 41.2 | 100.2 ± 20.8 |
| Day 21 | 114.5 ± 34.9 | 103.8 ± 21.3 |
| Day 28 | 122.5 ± 45.3 | 102.9 ± 24.1 |
Collected over From the time of enrollment through Day 60. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interventional | 0/20 (0%) | 0/20 (0%) | 2/20 (10%) |
| Placebo | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | Interventional | Placebo |
|---|---|---|
| Chest painCardiac disorders | 2/20 | — |
| Age, Continuous(years) | Interventional | Placebo | Total |
|---|---|---|---|
| Mean | 45.1 ± 11.9 | 41.6 ± 12.1 | 43.4 ± 12.0 |
| Sex: Female, Male(Participants) | Interventional | Placebo | Total |
|---|---|---|---|
| Female | 11 | 11 | 22 |
| Male | 9 | 9 | 18 |
| Race (NIH/OMB)(Participants) | Interventional | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 7 |
| White | 13 | 11 | 24 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 3 | 6 | 9 |
| Region of Enrollment(participants) | Interventional | Placebo | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.