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Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection

NCT04456413 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-10-10

Study results available
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Summary

* This is a phase II randomized study of convalescent plasma for the treatment of non-immune individuals with COVID-19 infection at high risk of complications.
* Subjects will be considered as having completed the study after 2 months (+/- 5) days, unless consent withdrawal or death occurs first.
* Subjects will be randomized to receiving convalescent plasma or best supportive care.
* Patients randomized to best supportive care may receive plasma should they require hospitalization for progression of COVID-19 disease.
* The final analysis will be conducted once the last subject completes the 2-month visit or withdraws from the study.

Conditions

Interventions

BIOLOGICAL

Convalescent Plasma

Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection

OTHER

Best Supportive Care

Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Michele L Donato, MD · Hackensack Meridian Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2021-04-29
Completion
2021-05-04
FDA Drug
Yes

Countries

  • United States

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 NCT04456413 on ClinicalTrials.gov