Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

May 4, 2023 updated by: U.S. Army Medical Research and Development Command

Expanded Access Protocol For The Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

This treatment protocol is designed to provide convalescent plasma as a therapeutic option for patients diagnosed with and hospitalized for COVID-19 with symptoms ranging from mild to life-threatening.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

This is an expanded access open-label, single-arm, multi-site protocol to provide convalescent plasma as a treatment for patients diagnosed with and hospitalized for COVID-19 with symptoms ranging from mild to life-threatening. Efficacy of this treatment will not be evaluated. A single site will initially be established. When additional patients needing therapy are identified at other health care facilities, Force Health Protection (FHP) will send a protocol package, and a site will be established and approved by the Headquarters USAMRDC Institutional Review Board (HQ IRB).

Study Type

Expanded Access

Expanded Access Type

  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Afghanistan
      • Bagram, Afghanistan
        • Craig Joint Theatre Hospital Bagram AFGH
  • Djibouti
      • Djibouti, Djibouti
        • Djibouti Expeditionary Medical Facility
  • Germany
      • Landstuhl, Germany
        • Landstuhl Regional Medical Center
  • Guam
      • Agaña, Guam
        • Naval Hospital Guam
  • Iraq
      • Baghdad, Iraq
        • Baghdad Diplomat Support Center Iraq
  • Japan
      • Aomori, Japan
        • Misawa Air Force Base
      • Fussa, Japan
        • Yokota Air Base
      • Okinawa, Japan
        • US Naval Hospital Okinawa
      • Yokosuka, Japan
        • Naval Hospital Yokosuka
      • Yokosuka, Japan
        • USS America
      • Yokosuka, Japan
        • USS Ronald Reagan
  • Kuwait
      • Kuwait, Kuwait
        • US Military Hospital Kuwait
  • United States
    • California
      • Oceanside, California, United States, 92055
        • Naval Hospital Camp Pendleton
      • San Diego, California, United States, 92134
        • Navy Medical Center San Diego
      • San Diego, California, United States, 92136
        • USS Abraham Lincoln
      • San Diego, California, United States, 92136
        • USS Carl Vinson
      • San Diego, California, United States, 92136
        • USS Essex
      • San Diego, California, United States, 92136
        • USS Makin Island
      • San Diego, California, United States, 92136
        • USS Nimitz
      • San Diego, California, United States, 92136
        • USS Theodore Roosevelt
    • Colorado
      • Fort Carson, Colorado, United States, 80913
        • Evans Army Community Hospital
    • Florida
      • Eglin Air Force Base, Florida, United States, 32542
        • Eglin Air Force Base
      • Jacksonville, Florida, United States, 32214
        • Naval Hospital Jacksonville
    • Georgia
      • Fort Benning, Georgia, United States, 31905
        • Martin Army Community Hospital
      • Fort Gordon, Georgia, United States, 30905
        • Eisenhower Army Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
    • Mississippi
      • Biloxi, Mississippi, United States, 39534
        • Keesler Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89191
        • Nellis Air Force Base
    • North Carolina
      • Camp Lejeune, North Carolina, United States, 28547
        • Naval Medical Center Camp Lejeune
    • Ohio
      • Wright-Patterson Air Force Base, Ohio, United States, 45433
        • Wright Patterson Medical Center
    • Texas
      • El Paso, Texas, United States, 79920
        • William Beaumont Army Medical Center
      • Fort Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center
    • Virginia
      • Fort Belvoir, Virginia, United States, 22060
        • Fort Belvoir Community Hospital
      • Norfolk, Virginia, United States, 23511
        • Naval Surface Force Atlantic
      • Norfolk, Virginia, United States, 23511
        • USS Dwight D. Eisenhower
      • Norfolk, Virginia, United States, 23511
        • USS Gerald R. Ford
      • Portsmouth, Virginia, United States, 23708
        • Naval Medical Center Portsmouth
    • Washington
      • Lakewood, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

A patient must meet the following criteria to be included in this protocol:

  • DoD personnel covered by the Force Health Protection (FHP) program under the Department of Defense Instruction (DoDI) 6200.02 (active duty service members OCONUS and CONUS) and non-DoD personnel who may be treated for COVID-19 at Military Treatment Facilities (MTFs) under the authority of DoDI 6200.03, including Military Health System (MHS) beneficiaries, patients admitted to MTFs, and patients cared for under defense support for civilian authorities (e.g. hospital ships, field hospitals deployed for the COVID-19 response).

  • Laboratory confirmed COVID-19 diagnosis

    • Both PCR and antigen tests are considered to be diagnostic
    • Serum antibody titer testing is not considered to be diagnostic, as patients who recently recovered from COVID-19 will still test positive)
  • Hospitalized with symptoms ranging from mild to life-threatening
  • Informed consent provided by the patient or legally authorized representative (LAR), except in situations described in 21 CFR 50.23
  • Understands and agrees to comply with planned protocol procedures

In general, adults with SARS-CoV-2 infection can be grouped into the following severity of illness categories. However, the criteria for each category may overlap or vary across clinical guidelines and clinical trials, and a patient's clinical status may change over time.

  • Asymptomatic or Presymptomatic Infection: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test or an antigen test) but who have no symptoms that are consistent with COVID-19.
  • Mild Illness: Individuals who have any of the various signs and symptoms of COVID-19 (eg, fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) but who do not have shortness of breath, dyspnea, or abnormal chest imaging.
  • Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94% on room air at sea level.
  • Severe Illness: Individuals who have SpO2 <94% on room air at sea level, a ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg, respiratory frequency >30 breaths/min, or lung infiltrates >50%.
  • Critical Illness: Individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction.

Exclusion Criteria:

Patients who have a medical contraindication for plasma transfusion will be excluded from participation in this protocol. Any patient not meeting the inclusion criteria will not be eligible to receive this treatment. Patients will not be excluded because of receipt of another COVID-19 treatment(s) unless the principal investigator (treating physician) feels that the patient would be put at risk by receiving multiple therapies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 20, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20-02
  • IND 19930 (Other Identifier: FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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