Convalescent Plasma in the Treatment of COVID 19
Purpose
The purpose of this study is to collect blood from previously COVID-19 infected persons who have recovered and use it as a treatment for those who are currently sick with a severe or life-threatening COVID-19 infection.
Conditions
- Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- COVID
- Coronavirus
Eligibility
- Eligible Ages
- Between 18 Years and 90 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- All genders - Age > 18 yrs and < 90 yrs - Must have laboratory confirmed COVID-19 - Must provide informed consent - Must have severe or immediately life-threatening COVID-19, Severe disease is defined as: - dyspnea, - respiratory frequency ≥ 30/min, - blood oxygen saturation ≤ 93%, - partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 - lung infiltrates > 50% within 24 to 48 hours Life-threatening disease is defined as: - respiratory failure, - septic shock - multiple organ dysfunction or failure
Exclusion Criteria
- No gender exclusion - Age < 18 yrs and > 90 yrs - COVID-19 negative
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental COVID-19 patients treated with convalescent plasma |
Severely ill COVID-19 patients treated with convalescent plasma |
|
Recruiting Locations
More Details
- NCT ID
- NCT04343261
- Status
- Completed
- Sponsor
- Trinity Health Of New England
Detailed Description
The purpose of this prospective interventional study is to gain clinical experience using convalescent plasma transfusion administered to critically ill patients with COVID-19. 1 To study the efficacy of plasma from patients recovered from COVID-19 infection with a high neutralizing antibody titer (NAT) as treatment for individuals who are critically ill with COVID-19. 2. Determine if the antibodies from convalescent plasma will suppress virus load in critically ill patients with COVID-19.