CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,225 enrolled
Drug / intervention
SARS-CoV-2 convalescent plasma +1 morebiological
Likely dose
SARS-CoV-2 convalescent plasma 175 mLfrom 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/NCT04373460
NCT04373460Phase 2Completed
CompareCT.gov

Comparison of the Efficacy and Safety of Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune) Plasma Among Outpatients With Symptomatic COVID-19

Johns Hopkins University·interventional·Posted May 4, 2020·Updated Jun 2, 2023

In Brief

A Phase 2 clinical trial evaluating SARS-CoV-2 convalescent plasma and Plasma from a volunteer donor for SARS-CoV 2. Completed, enrolled 1,225 participants across 29 sites.

Detailed Summary

To assess the efficacy and safety of Human coronavirus immune plasma (HCIP) to reduce the risk of hospitalization or death, the duration of symptoms and duration of nasopharyngeal or oropharyngeal viral shedding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV 2
CountriesUnited States
CollaboratorsState of Maryland, Bloomberg Philanthropies, United States Department of Defense, National Institute of Allergy and Infectious Diseases (NIAID), National Center for Advancing Translational Sciences (NCATS)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 4, 2020
Enrollment StartJun 3, 2020
Primary CompletionJan 14, 2022
Study CompletionDec 14, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.2 years ago

Interventions

SARS-CoV-2 convalescent plasmabiological

SARS-CoV-2 convalescent plasma (1 cup; minimum of 175 mL collected by apheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320 and after July 2021 meets FDA criteria for high titer plasma.

Plasma from a volunteer donorbiological

Plasma collected from a volunteer donor prior to January 1, 2020 will not be tested for SARS-CoV-2 antibodies. Plasma collected after December 31, 2019 will be confirmed as SARS-CoV-2 seronegative.