Convalescent Plasma for Patients With COVID-19
Purpose
Pilot study of tolerability and efficacy of transfusion of 200mL of convalescent plasma in patients with COVID-19 respiratory disease.
Conditions
- Coronavirus Infection
- Coronavirus
- COVID
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- age > 18 with one or more of the following: Dyspnea Respiratory rate >= 30 breaths/min Oxygen saturation <=93% PaO2/FiO2 <300 Bilateral airspace opacities on chest radiograph at 24 to 48 hours
Exclusion Criteria
- Acute myocardial infarction in past 30 days Acute stroke in past 30 days VV ECMO VA ECMO
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Randomized control trial
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Convalescent Plasma Intervention |
Convalescent plasma 200mL transfusion |
|
|
No Intervention Standard Therapy Control |
Standard therapy for COVID-19 disease as defined by institutional protocols |
|
Recruiting Locations
More Details
- NCT ID
- NCT04385199
- Status
- Completed
- Sponsor
- Henry Ford Health System
Detailed Description
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.