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Purpose

Evaluate the efficacy of treatment with high-titer Anti- SARS-CoV-2 plasma versus control (SARS-CoV-2 non-immune plasma) in subjects exposed to Coronavirus disease (COVID-19) at day 28.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Subjects must be 18 years of age or older 2. Close contact exposure (as defined by CDC guidelines) to person with COVID-19 within 96 hours of randomization (and 120 hours of receipt of plasma)

Exclusion Criteria

  1. Receipt of any blood product in past 120 days. 2. Medical, psychiatric,cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance. 3. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening. 4. Laboratory evidence of COVID-19 infection at time of screening. 5. History or known laboratory evidence of previous COVID-19 infection. 6. History of prior reactions to transfusion blood products. 7. Inability to complete therapy with the study product within 24 hours after randomization.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
1:1 ratio
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
High titer anti-SARS-CoV-2 plasma 		Participants with High titer anti-SARS-CoV-2 plasma.
  • Biological: Anti- SARS-CoV-2 Plasma
    SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
Active Comparator
SARS-CoV-2 non-immune plasma 		Participants with SARS-CoV-2 non-immune plasma.
  • Biological: SARS-CoV-2 non-immune Plasma
    Normal human plasma collected prior to December 2019

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Faye Heard
206-996-4405
fhoward@uabmc.edu

Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona 85941
Contact:
Robert Weatherholtz
410-955-6931
rweathe1@jhu.edu

University of California, San Diego
La Jolla, California 92093
Contact:
Leander Lazaro
858-822-3708
llazaro@health.ucsd.edu

University of California, Los Angeles
Los Angeles, California 90095
Contact:
Jenny Ahn
310-267-2273
JennyAhn@mednet.ucla.edu

University of California, Irvine Health
Orange, California 92868
Contact:
Anthony Warner
949-824-1114
acwarner@hs.uci.edu

Western Connecticut Health Network, Danbury Hospital
Danbury, Connecticut 06810
Contact:
Marie Elena Cordisco
203-739-7353

Western Connecticut Health Netowrk, Norwalk Hospital
Norwalk, Connecticut 06856
Contact:
Marie Elena Cordisco
203-739-7353

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Max Menna
202-444-0357
mpm229@georgetown.edu

University of Miami Clinical Translational Research Site
Miami, Florida 33136
Contact:
Shweta Anjan
786-975-1800
covidplasmastudy@miami.edu

NorthShore University HealthSystem
Evanston, Illinois 60201
Contact:
Brittney Adams
BAdams@northshore.org

Anne Arundel Medical Center
Annapolis, Maryland 21401
Contact:
Jaci Miller
443-481-5738
jmiller9@aahs.org

The Johns Hopkins University
Baltimore, Maryland 21205
Contact:
Thuy Anderson, RN
443-287-8942
tander34@jhmi.edu

University of Massachusetts Worcester
Worcester, Massachusetts 01655
Contact:
Alexandra Agrillo
774-455-4456
UMassCOVIDplasma@umassmed.edu

Wayne State University
Detroit, Michigan 48202
Contact:
Thomas Mazzocco
313-966-1829
tmazzocco@wayne.edu

Center for American Indian Health - Gallup Office
Gallup, New Mexico 87301
Contact:
Robert Weatherholtz
410-955-6931
rweathe1@jhu.edu

Center for American Indian Health - Shiprock Office
Shiprock, New Mexico 87420
Contact:
Robert Weatherholtz
410-955-6931
rweathe1@jhu.edu

Vassar Brothers Medical Center
Poughkeepsie, New York 12601
Contact:
William Rausch
845-483-6323

University of Rochester
Rochester, New York 14642
Contact:
Susanne Heininger
585-273-1926
Susanne_Heininger@URMC.Rochester.edu

University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Contact:
Sharon Kohrs
513-584-6383
kohrssd@ucmail.uc.edu

Lifespan/BrownUniversity (Rhode Island Hospital)
Providence, Rhode Island 02903
Contact:
Kristin Basso
401-444-2936
kristin.basso@lifespan.org

University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Mary Ayad
713-704-5198
mary.ayad@uth.tmc.edu

More Details

NCT ID
NCT04323800
Status
Recruiting
Sponsor
Johns Hopkins University

Study Contact

Shmuel Shoham, MD
410-614-6702
TOID_CRC@jhmi.edu

Detailed Description

This randomized, controlled, double-blinded phase 2 trial will assess the efficacy and safety of Anti- SARS-CoV-2 convalescent plasma as prophylaxis following exposure to COVID-19 (as defined in the inclusion criteria). Adults 18 years of age and older with high risk exposure as defined by CDC may participate. A total of 500 eligible subjects will be randomized in a 1:1 ratio to receive either high titer anti-SARS-CoV-2 plasma or control (SARS-CoV-2 non-immune plasma).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.