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Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

NCT04392414 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-25

No results posted yet for this study

Summary

The clinical trial aims to study the safety and efficacy of transfusion of COVID-19 convalescent hyperimmune plasma for the treatment of moderate and severe forms of COVID-19 disease in comparison with non-convalescent fresh frozen plasma (standard plasma).

Conditions

Interventions

BIOLOGICAL

COVID-19 convalescent hyperimmune plasma

Subjects to receive double convalescent hyperimmune plasma units of 300 ml each, with the 2nd unit administered no later than 24 hrs after the first one

BIOLOGICAL

Non-convalescent fresh frozen plasma (Standard plasma)

Subjects to receive double standard plasma units of 300 ml each, with the 2nd unit administered no later than 24 hrs after the first one

Sponsors & Collaborators

  • Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

    lead OTHER_GOV

Principal Investigators

  • Alexander V Averyanov, MD, PhD · Federal Pulmonology Scientific and Research Institute, FMBA of Russia

  • Vladimir P Baklaushev, MD, PhD · Federal Research Clinical Center, FMBA of Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2020-07-10
Completion
2020-09-23

Countries

  • Russia

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 NCT04392414 on ClinicalTrials.gov