CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
COVID-19 Convalescent Plasma (CCP) +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/NCT04421404
NCT04421404Phase 2Completed

A Randomized Controlled Adaptive Study Comparing COVID-19 Convalescent Plasma (CCP) to Non-immune Plasma to Limit Coronavirus-associated Complications in Hospitalized Patients

Priscilla Hsue, MD·interventional·Posted Jun 9, 2020·Updated Oct 7, 2022

In Brief

A Phase 2 clinical trial evaluating COVID-19 Convalescent Plasma (CCP) and Placebo for COVID-19 and Sars-CoV2. Completed, enrolled 34 participants across 3 sites.

Detailed Summary

The purpose of this study assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms up to 14 days after the onset of initial symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19, Sars-CoV2
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 9, 2020
Enrollment StartJun 9, 2020
Primary CompletionApr 30, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.1 years ago

Interventions

COVID-19 Convalescent Plasma (CCP)biological

COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.

Placebobiological

Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.