Plasma Therapy of COVID-19 in Severely Ill Patients

Status Completed

Clinical Trial Summary

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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

SARS-CoV-2 Infection

Clinical Trial Details

NCT number	NCT04359810
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	Phase 2
Start date	April 21, 2020
Completion date	December 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04555096` - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19	Phase 2
Completed	`NCT04593641` - This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)	Phase 1
Recruiting	`NCT05200754` - Trial With or Without Infusion of SARS-CoV-2 Antibody Containing Plasma in High-Risk Patients With COVID-19	Phase 2
Completed	`NCT04583995` - A Study Looking at the Effectiveness, Immune Response, and Safety of a COVID-19 Vaccine in Adults in the United Kingdom	Phase 3
Recruiting	`NCT06255860` - SARS-COV-2 Reinfection and Multisystem Inflammatory Syndrome in Children (MIS-C) Risk: Matched Case-control Study
Recruiting	`NCT04516811` - Therapeutic Use of Convalescent Plasma in the Treatment of Patients With Moderate to Severe COVID-19	Phase 3
Recruiting	`NCT05012826` - Osteopathy and Physiotherapy Compared to Physiotherapy Alone on Fatigue and Functional Status in Long COVID	N/A
Completed	`NCT05007236` - Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.	Phase 2
Recruiting	`NCT06026514` - Phase I Safety Study of B/HPIV3/S-6P Vaccine Via Nasal Spray in Adults	Phase 1
Completed	`NCT05523739` - Safety and Efficacy Study of STI-1558 in Healthy Adults and SARS-CoV-2-Positive Patients	Phase 1
Suspended	`NCT04738136` - Safety, Tolerability and Efficacy Of S-1226 in Moderate Severity Covid-19 Bronchiolitis/Pneumonia	Phase 2
Recruiting	`NCT04584658` - Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Recruiting	`NCT04547114` - Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Completed	`NCT05119348` - Transmission of Coronavirus Disease 2019 (COVID19) in Crowded Environments	N/A
Completed	`NCT05096962` - COVID-19: SARS-CoV-2-CZ-PREVAL-II Study
Recruiting	`NCT04534400` - Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
Completed	`NCT04527354` - Pilot Study to Assess Efficacy and Safety of Treamid in the Rehabilitation of Patients After COVID-19 Pneumonia	Phase 2
Completed	`NCT04583982` - ImmuneSense™ COVID-19 Study
Completed	`NCT05077176` - Phase 3 Booster Vaccination Against COVID-19	Phase 3
Completed	`NCT05584189` - COVID-19 MP Biomedicals Rapid SARS-CoV-2 Antigen Test Usability	N/A