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

NCT04343755 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-09-18

Study results available
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Summary

* This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.
* Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.
* Interim analysis will be permitted as described in the statistical section 8.
* The final analysis will be conducted once the last subject completes the day 60 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

Sponsors & Collaborators

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Michele L Donato, MD · Hackensack Meridian Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-09
Primary Completion
2023-04-26
Completion
2023-04-26
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 NCT04343755 on ClinicalTrials.gov