CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 223 enrolled
Drug / intervention
Convalescent Plasma (anti-SARS-CoV-2 plasma) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04359810
NCT04359810Phase 2Completed
CompareCT.gov

A Phase 2, Multi-Center, Randomized Clinical Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Convalescent Plasma in Severely Ill Adults With COVID-19

Max O'Donnell·interventional·Posted Apr 24, 2020·Updated Sep 19, 2024

In Brief

A Phase 2 clinical trial evaluating Convalescent Plasma (anti-SARS-CoV-2 plasma) and Non-convalescent Plasma (control plasma) for SARS-CoV-2 Infection. Completed, enrolled 223 participants across 4 sites in 2 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2 Infection
CountriesBrazil, United States
CollaboratorsNew York Blood Center, Amazon, Inc.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedApr 24, 2020
Enrollment StartApr 21, 2020
Primary CompletionDec 30, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 6.2 years ago

Interventions

Convalescent Plasma (anti-SARS-CoV-2 plasma)biological

Convalescent Plasma that contains antibody titers against SARS-CoV-2

Non-convalescent Plasma (control plasma)biological

Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)