Plasma Therapy of COVID-19 in Severely Ill Patients

Max O'Donnell

Status and phase

Completed

Phase 2

Conditions

SARS-CoV-2 Infection

Treatments

Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma)

Biological: Non-convalescent Plasma (control plasma)

Study type

Interventional

Funder types

Other

Identifiers

NCT04359810

AAAS9924

Details and patient eligibility

About

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).

Full 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.

Enrollment

223 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.