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Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients

NCT04524507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-12-03

Study results available
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Summary

The purpose of this research study is to find out if CCP is safe and to determine the safest and most effective level of anti-viral antibody when given to people admitted to the hospital with confirmed COVID-19 infection. Participants enrolled on this study will be transfused with 2 units of CCP through an IV. These units will be given one at a time 4 to 24 hours apart. Participants will be randomized to receive either 2 units with standard antibody levels as recommended by the FDA or 2 units with an antibody level higher than that recommended by the FDA. This study is experimental and CCP is investigational and has not been approved by the FDA for the treatment of COVID-19. The CCP is collected per FDA guidelines from persons recovered from COVID-19 infection. The plasma contains antibodies and possibly other properties that inhibit the virus. The investigators do not know if the level of antibodies present in the CCP will make a difference in how the participant's body is able to fight the infection and hope to learn that in this study.

Conditions

Interventions

BIOLOGICAL

High-titer Convalescent COVID-19 Plasma (CCP1)

At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.

BIOLOGICAL

Standard-titer Convalescent COVID-19 plasma (CCP2)

At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.

Sponsors & Collaborators

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Luther A Bartelt, MD · UNC-Chapel Hill

  • David M Margolis, MD · UNC-Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-08-27
Primary Completion
2021-01-04
Completion
2021-06-04
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 NCT04524507 on ClinicalTrials.gov