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

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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