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

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).

No longer available
Treatment IND/Protocol
Severe Acute Respiratory Syndrome Coronavirus 2

Biological: Anti-Sars-CoV-2 Convalescent Plasma

Fresh frozen plasma, Plasma Frozen for 24 hours (PF-24), or Liquid plasma

Eligibility Criteria

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

- 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.

Eligibility Gender
Eligibility Age
Minimum: N/A ~ Maximum: N/A
United States

Naval Hospital Camp Pendleton
Oceanside, California, United States

Navy Medical Center San Diego
San Diego, California, United States

USS Abraham Lincoln
San Diego, California, United States

USS Carl Vinson
San Diego, California, United States

USS Essex
San Diego, California, United States

USS Makin Island
San Diego, California, United States

USS Nimitz
San Diego, California, United States

USS Theodore Roosevelt
San Diego, California, United States

Evans Army Community Hospital
Fort Carson, Colorado, United States

Eglin Air Force Base
Eglin Air Force Base, Florida, United States

Naval Hospital Jacksonville
Jacksonville, Florida, United States

Martin Army Community Hospital
Fort Benning, Georgia, United States

Eisenhower Army Medical Center
Fort Gordon, Georgia, United States

Tripler Army Medical Center
Honolulu, Hawaii, United States

Keesler Medical Center
Biloxi, Mississippi, United States

Nellis Air Force Base
Las Vegas, Nevada, United States

Naval Medical Center Camp Lejeune
Camp Lejeune, North Carolina, United States

Wright Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, United States

William Beaumont Army Medical Center
El Paso, Texas, United States

Brooke Army Medical Center
Fort Sam Houston, Texas, United States

Fort Belvoir Community Hospital
Fort Belvoir, Virginia, United States

Naval Surface Force Atlantic
Norfolk, Virginia, United States

USS Dwight D. Eisenhower
Norfolk, Virginia, United States

USS Gerald R. Ford
Norfolk, Virginia, United States

Naval Medical Center Portsmouth
Portsmouth, Virginia, United States

Madigan Army Medical Center
Lakewood, Washington, United States

Craig Joint Theatre Hospital Bagram AFGH
Bagram, Afghanistan

Djibouti Expeditionary Medical Facility
Djibouti, Djibouti

Landstuhl Regional Medical Center
Landstuhl, Germany

Naval Hospital Guam
Agaña, Guam

Baghdad Diplomat Support Center Iraq
Baghdad, Iraq

Misawa Air Force Base
Aomori, Japan

Yokota Air Base
Fussa, Japan

US Naval Hospital Okinawa
Okinawa, Japan

Naval Hospital Yokosuka
Yokosuka, Japan

USS America
Yokosuka, Japan

USS Ronald Reagan
Yokosuka, Japan

US Military Hospital Kuwait
Kuwait, Kuwait

U.S. Army Medical Research and Development Command
NCT Number
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome