A Phase 2 interventional study of Convalescent plasma in Coronavirus Infection, Coronavirus and COVID, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Henry Ford Health System · Phase 2, Interventional, and Treatment
Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.
Importance: Convalescent plasma has been shown to be safe in patients with COVID-19, but whether it is clinically effective in patients with severe COVID-19 pneumonia is still unclear.
Objective: To evaluate the safety, tolerability, efficacy, and adverse events related to transfusion of convalescent plasma in patients hospitalized with severe or critical COVID-19 pneumonia.
Design, Setting and Participants: Randomized, single center, open-label, controlled trial of patients hospitalized between May 1, 2020, and August 1, 2020, with severe COVID-19 pneumonia in 1 tertiary care health system in the United States. A total of 30 participants age ≥ 18 years with 1 or more of the following were enrolled: dyspnea; respiratory rate > 30; O2 saturation ≤ 93%; PaO2/FiO2 or SaO2/FiO2 ratio \< 300 mm Hg; and bilateral airspace opacities on chest x-ray > 50% within 24 to 48 hours.
Intervention: Transfusion with 1 unit of ABO compatible convalescent plasma in addition to standard care (n = 20) or standard care (n = 10). Standard care included steroids.
Main Outcomes and Measures: Primary outcome was improvement in oxygenation 72 hours after infusion measured by change in arterial blood gas or in PaO2/FiO2 or Sa/FiO2. Secondary outcomes were mortality at 28 days, days on mechanical ventilation, intensive care unit and hospital length of stay, and mSOFA score.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Convalescent plasma 200mL transfusion
Biological: Convalescent plasma
Standard therapy for COVID-19 disease as defined by institutional protocols
One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
Change in Respiratory Disease Severity
Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion
Time frame: day 3 post transfusion
ICU Length of Stay
Total ICU length of stay
Time frame: Up to 60 days At the end of the trial, if patients were still in the ICU, their date of transfer out of the ICU was collected and total ICU length of stay calculated.
Length of Stay
Hospital length of stay
Time frame: Up to 60 days At the end of the trial, if patients were still in the hospital, their date of transfer out of the hospital was collected and hospital length of stay calculated.
Ventilator Days
Duration of time on ventilator
Time frame: 28 day
Number of Participants With Transfusion Adverse Events
Adverse transfusion events after 1 unit of convalescent plasma
Time frame: From transfusion up to 1 day post-transfusion
Normal Chest X Ray at 28 Days
Change in Chest X Ray Findings
Time frame: 28 days
All-cause Mortality
All-cause overall deaths at end of trial at 28 days
Time frame: 28 days
| Milestone | Convalescent Plasma Intervention | Standard Therapy Control |
|---|---|---|
| Started | 20 | 10 |
| Completed | 19 | 10 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
Change in oxygenation as documented by SaO2/FiO2 at 72 hours after infusion
| ratio | Convalescent Plasma Intervention | Standard Therapy Control |
|---|---|---|
| Change in Respiratory Disease Severity | 251 ± 89 | 276 ± 188 |
Total ICU length of stay
| days | Convalescent Plasma Intervention | Standard Therapy Control |
|---|---|---|
| ICU Length of Stay | 19.5 (10 to 46) | 13 (10 to 19) |
Hospital length of stay
| days | Convalescent Plasma Intervention | Standard Therapy Control |
|---|---|---|
| Length of Stay | 20 (7.5 to 46) | 11.5 (9 to 18) |
Duration of time on ventilator
| days | Convalescent Plasma Intervention | Standard Therapy Control |
|---|---|---|
| Ventilator Days | 15.6 (8.4 to 26) | 4.2 (1.4 to 7.5) |
Adverse transfusion events after 1 unit of convalescent plasma
| participants | Convalescent Plasma Intervention | Standard Therapy Control |
|---|---|---|
| Number of Participants With Transfusion Adverse Events | 0 | 0 |
Change in Chest X Ray Findings
| Participants | Convalescent Plasma Intervention | Standard Therapy Control |
|---|---|---|
| Normal Chest X Ray at 28 Days | 9 | 3 |
All-cause overall deaths at end of trial at 28 days
| Participants | Convalescent Plasma Intervention | Standard Therapy Control |
|---|---|---|
| All-cause Mortality | 3 | 2 |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 3/20 (15%) | 0/20 (0%) | 0/20 (0%) |
| Control | 2/10 (20%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Convalescent Plasma Intervention | Standard Therapy Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 3 | 8 |
| >=65 years | 15 | 7 | 22 |
| Age, Continuous(years) | Convalescent Plasma Intervention | Standard Therapy Control | Total |
|---|---|---|---|
| Mean | 56.6 ± 13.9 | 53 ± 13.6 | 55 ± 13 |
| Sex: Female, Male(Participants) | Convalescent Plasma Intervention | Standard Therapy Control | Total |
|---|---|---|---|
| Female | 9 | 4 | 13 |
| Male | 11 | 6 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Convalescent Plasma Intervention | Standard Therapy Control | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 8 |
| Not Hispanic or Latino | 13 | 3 | 16 |
| Unknown or Not Reported | 4 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Convalescent Plasma Intervention | Standard Therapy Control | 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 | 13 | 3 | 16 |
| White | 3 | 5 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 2 | 6 |
| Region of Enrollment(participants) | Convalescent Plasma Intervention | Standard Therapy Control | Total |
|---|---|---|---|
| United States | 20 | 10 | 30 |
| Dyspnea with Respiratory Rate (RR) >30(Participants) | Convalescent Plasma Intervention | Standard Therapy Control | Total |
|---|---|---|---|
| Count of participants | 9 | 4 | 13 |
| SaO2/FiO2(ratio) | Convalescent Plasma Intervention | Standard Therapy Control | Total |
|---|---|---|---|
| Mean | 188.4 ± 96.0 | 196.5 ± 89.9 | 190 ± 90 |
2 further baseline measures are reported on the registry.
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