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.



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

  1. Subjects must be 18 years of age or older.
  2. Close contact* exposure to person with COVID-19 within 96 hours of enrollment (and 120 hours of receipt of plasma) defined as:
  3. 1 Living in the same household as, being an intimate partner of, or providing care in a non-healthcare setting (such as a home) for a person with symptomatic laboratory-confirmed COVID-19 infection without using recommended precautions for home care and home isolation.
  4. 2 HCP who have had prolonged close contact with patients with COVID-19 who were not wearing a face mask while HCP nose and mouth were exposed to material potentially infectious with the virus causing COVID-19.
  5. 3 Being present in the room for procedures that generate aerosols or during which respiratory secretions are likely to be poorly controlled (e.g., cardiopulmonary resuscitation, intubation, extubation, bronchoscopy, nebulizer therapy, sputum induction) on patients with COVID-19 when the healthcare providers' eyes, nose, or mouth were not protected.

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 enrollment.

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
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

MedStar Georgetown University Hospital
Washington, District of Columbia 20007
Max Menna

More Details

Johns Hopkins University

Study Contact

Shmuel Shoham, MD

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).


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.