Clinical trial NCT04360486: Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)
Official title: Expanded Access Protocol For The Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2020-04-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

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).

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oceanside
country: United States
facility: Naval Hospital Camp Pendleton
state: California
city: San Diego
country: United States
facility: Navy Medical Center San Diego
state: California
city: San Diego
country: United States
facility: USS Abraham Lincoln
state: California
city: San Diego
country: United States
facility: USS Carl Vinson
state: California
city: San Diego
country: United States
facility: USS Essex
state: California
city: San Diego
country: United States
facility: USS Makin Island
state: California
city: San Diego
country: United States
facility: USS Nimitz
state: California
city: San Diego
country: United States
facility: USS Theodore Roosevelt
state: California
city: Fort Carson
country: United States
facility: Evans Army Community Hospital
state: Colorado
city: Eglin Air Force Base
country: United States
facility: Eglin Air Force Base
state: Florida
city: Jacksonville
country: United States
facility: Naval Hospital Jacksonville
state: Florida
city: Fort Benning
country: United States
facility: Martin Army Community Hospital
state: Georgia
city: Fort Gordon
country: United States
facility: Eisenhower Army Medical Center
state: Georgia
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: Biloxi
country: United States
facility: Keesler Medical Center
state: Mississippi
city: Las Vegas
country: United States
facility: Nellis Air Force Base
state: Nevada
city: Camp Lejeune
country: United States
facility: Naval Medical Center Camp Lejeune
state: North Carolina
city: Wright-Patterson Air Force Base
country: United States
facility: Wright Patterson Medical Center
state: Ohio
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Fort Belvoir
country: United States
facility: Fort Belvoir Community Hospital
state: Virginia
city: Norfolk
country: United States
facility: Naval Surface Force Atlantic
state: Virginia
city: Norfolk
country: United States
facility: USS Dwight D. Eisenhower
state: Virginia
city: Norfolk
country: United States
facility: USS Gerald R. Ford
state: Virginia
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
city: Lakewood
country: United States
facility: Madigan Army Medical Center
state: Washington
city: Bagram
country: Afghanistan
facility: Craig Joint Theatre Hospital Bagram AFGH
city: Djibouti
country: Djibouti
facility: Djibouti Expeditionary Medical Facility
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
city: Agaña
country: Guam
facility: Naval Hospital Guam
city: Baghdad
country: Iraq
facility: Baghdad Diplomat Support Center Iraq
city: Aomori
country: Japan
facility: Misawa Air Force Base
city: Fussa
country: Japan
facility: Yokota Air Base
city: Okinawa
country: Japan
facility: US Naval Hospital Okinawa
city: Yokosuka
country: Japan
facility: Naval Hospital Yokosuka
city: Yokosuka
country: Japan
facility: USS America
city: Yokosuka
country: Japan
facility: USS Ronald Reagan
city: Kuwait
country: Kuwait
facility: US Military Hospital Kuwait
Study officials:
References: