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

Sponsor
U.S. Army Medical Research and Development Command (U.S. Fed)
Overall Status
No longer available
CT.gov ID
NCT04360486
Collaborator
(none)
38
Locations

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Anti-Sars-CoV-2 Convalescent Plasma

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 Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Naval Hospital Camp Pendleton Oceanside California United States 92055
    2 Navy Medical Center San Diego San Diego California United States 92134
    3 USS Abraham Lincoln San Diego California United States 92136
    4 USS Carl Vinson San Diego California United States 92136
    5 USS Essex San Diego California United States 92136
    6 USS Makin Island San Diego California United States 92136
    7 USS Nimitz San Diego California United States 92136
    8 USS Theodore Roosevelt San Diego California United States 92136
    9 Evans Army Community Hospital Fort Carson Colorado United States 80913
    10 Eglin Air Force Base Eglin Air Force Base Florida United States 32542
    11 Naval Hospital Jacksonville Jacksonville Florida United States 32214
    12 Martin Army Community Hospital Fort Benning Georgia United States 31905
    13 Eisenhower Army Medical Center Fort Gordon Georgia United States 30905
    14 Tripler Army Medical Center Honolulu Hawaii United States 96859
    15 Keesler Medical Center Biloxi Mississippi United States 39534
    16 Nellis Air Force Base Las Vegas Nevada United States 89191
    17 Naval Medical Center Camp Lejeune Camp Lejeune North Carolina United States 28547
    18 Wright Patterson Medical Center Wright-Patterson Air Force Base Ohio United States 45433
    19 William Beaumont Army Medical Center El Paso Texas United States 79920
    20 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
    21 Fort Belvoir Community Hospital Fort Belvoir Virginia United States 22060
    22 Naval Surface Force Atlantic Norfolk Virginia United States 23511
    23 USS Dwight D. Eisenhower Norfolk Virginia United States 23511
    24 USS Gerald R. Ford Norfolk Virginia United States 23511
    25 Naval Medical Center Portsmouth Portsmouth Virginia United States 23708
    26 Madigan Army Medical Center Lakewood Washington United States 98431
    27 Craig Joint Theatre Hospital Bagram AFGH Bagram Afghanistan
    28 Djibouti Expeditionary Medical Facility Djibouti Djibouti
    29 Landstuhl Regional Medical Center Landstuhl Germany
    30 Naval Hospital Guam Agaña Guam
    31 Baghdad Diplomat Support Center Iraq Baghdad Iraq
    32 Misawa Air Force Base Aomori Japan
    33 Yokota Air Base Fussa Japan
    34 US Naval Hospital Okinawa Okinawa Japan
    35 Naval Hospital Yokosuka Yokosuka Japan
    36 USS America Yokosuka Japan
    37 USS Ronald Reagan Yokosuka Japan
    38 US Military Hospital Kuwait Kuwait Kuwait

    Sponsors and Collaborators

    • U.S. Army Medical Research and Development Command

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    U.S. Army Medical Research and Development Command
    ClinicalTrials.gov Identifier:
    NCT04360486
    Other Study ID Numbers:
    • S-20-02
    • IND 19930
    First Posted:
    Apr 24, 2020
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Coronavirus Infections
    Severe Acute Respiratory Syndrome
    COVID-19

    Study Results

    No Results Posted as of Mar 4, 2022