MedTrace Logo

A Clinical Trial of Convalescent Plasma Compared to Best Supportive Care for Treatment of Patients With Severe COVID-19

NCT04433910 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-09-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Convalesscent Plasma

Transfusion

Sponsors & Collaborators

  • Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen

    lead OTHER

Principal Investigators

  • Hubert Schrezenmeier, Prof.Dr. · IKT Ulm

  • Erhard Seifried, Prof.Dr.Dr. · German Red Cross Blood Service

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-30
Primary Completion
2021-01-21
Completion
2022-03-25

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04433910 on ClinicalTrials.gov