Plasma Therapy of COVID-19 in Severely Ill Patients
Purpose
This randomized blinded multi-center phase 2 trial will assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma among adults with severe COVID-19. Adults ≥18 years of age may participate. A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either high-titer anti-SARS-CoV-2 plasma or non-convalescent fresh frozen plasma (control plasma).
Condition
- SARS-CoV-2 Infection
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Willing and able to provide written informed consent prior to performing study procedures or have a legally authorized representative available to do so. - Age ≥18 years - Evidence of SARS-CoV-2 infection by PCR test of naso-/oro-pharyngeal swab or tracheal aspirate sample within 14 days of randomization - Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air or requiring supplemental oxygen, non-invasive or invasive mechanical ventilation at screening - Evidence of infiltrates on chest radiography - Females of childbearing age and males, must be willing to practice an effective contraceptive method or remain abstinent during the study period.
Exclusion Criteria
- Participation in another clinical trial of anti-viral agent(s) for COVID-19 - Receipt of any anti-viral agent(s) with possible activity against SARS-CoV-2 <24 hours prior to study drug administration [1] - Mechanically ventilated (including veno-venous (VV)-ECMO) ≥ 5 days - Severe multi-organ failure - History of prior reactions to transfusion blood products meeting definitive case definition criteria, at least severe severity, and probable or definite imputability per National Healthcare Safety Network (NHSN)/Centers for Disease Control and Prevention (CDC) criteria - Known Immunoglobulin A (IgA) deficiency - Females who are pregnant 1. Use of remdesivir as treatment for COVID-19 is permitted.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- A total of 219 eligible subjects will be randomized in a 2:1 ratio to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody (anti-SARS-CoV-2 plasma) or non-convalescent fresh frozen plasma (control plasma).
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Convalescent Plasma (anti-SARS-CoV-2 plasma) |
Convalescent plasma (1 unit; ~200-250 mL) collected from a volunteer who recovered from COVID-19 disease |
|
|
Active Comparator Non-convalescent Plasma (control plasma) |
Non-convalescent plasma (1 unit; ~200-250 mL) of standard plasma collected prior to December 2019 |
|
Recruiting Locations
More Details
- NCT ID
- NCT04359810
- Status
- Completed
- Sponsor
- Max O'Donnell
Detailed Description
There are few effective therapies for coronavirus disease 2019 (COVID-19) associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS-CoV). Small clinical trials and observational studies of CP therapy in patients with COVID-19 have suggested a possible clinical benefit.