CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
Convalesscent Plasmadrug
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/NCT04433910
NCT04433910Phase 2Completed

A Randomized, Prospective, Open Label Clinical Trial on the Use of Convalescent Plasma Compared to Best Supportive Care in Patients With Severe COVID-19

Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen·interventional·Posted Jun 16, 2020·Updated Sep 14, 2023

In Brief

A Phase 2 clinical trial evaluating Convalesscent Plasma for COVID-19. Completed, enrolled 106 participants across 16 sites.

Detailed Summary

This is a randomized, prospective, multicenter, open label clinical trial of convalescent plasma compared to best supportive care for treatment of patients with severe COVID-19. The aim of the study is to explore the therapeutic effect of convalescent plasma transfusions on the survival and course of disease of patients with severe COVID-19. Convalescent plasma will be collected from recovered COVID-19 patients. Patients with severe COVID-19 will be randomly assigned to two groups. Patients in the treatment group will receive covalescent plasma (250 - 325 ml) on days 1, 3 and 5. Patients in the control group will receive best supportive care. Clinical condition in all patients will be evaluated on day 14. In case of progressive COVID-19 on day 14 compared to baseline, patients in the control group may be switched to treatment with convalescent plasma on days 15, 17 and 19. Fifty-three patients will be included in each group. Data of each patient will be collected until discharge but nor longer than day 60.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJun 16, 2020
Enrollment StartAug 30, 2020
Primary CompletionJan 21, 2021
Study CompletionMar 25, 2022
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 6.0 years ago

Interventions

Convalesscent Plasmadrug

Transfusion