Purpose

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

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Study Type
Expanded Access

Recruiting Locations

Naval Hospital Camp Pendleton
Oceanside, California 92055

Navy Medical Center San Diego
San Diego, California 92134

USS Abraham Lincoln
San Diego, California 92136

USS Carl Vinson
San Diego, California 92136

USS Essex
San Diego, California 92136

USS Makin Island
San Diego, California 92136

USS Nimitz
San Diego, California 92136

USS Theodore Roosevelt
San Diego, California 92136

Evans Army Community Hospital
Fort Carson, Colorado 80913

Eglin Air Force Base
Eglin Air Force Base, Florida 32542

Naval Hospital Jacksonville
Jacksonville, Florida 32214

Martin Army Community Hospital
Fort Benning, Georgia 31905

Eisenhower Army Medical Center
Fort Gordon, Georgia 30905

Tripler Army Medical Center
Honolulu, Hawaii 96859

Keesler Medical Center
Biloxi, Mississippi 39534

Nellis Air Force Base
Las Vegas, Nevada 89191

Naval Medical Center Camp Lejeune
Camp Lejeune, North Carolina 28547

Wright Patterson Medical Center
Wright-Patterson Air Force Base, Ohio 45433

William Beaumont Army Medical Center
El Paso, Texas 79920

Brooke Army Medical Center
Fort Sam Houston, Texas 78234

Fort Belvoir Community Hospital
Fort Belvoir, Virginia 22060

Naval Surface Force Atlantic
Norfolk, Virginia 23511

USS Dwight D. Eisenhower
Norfolk, Virginia 23511

USS Gerald R. Ford
Norfolk, Virginia 23511

Naval Medical Center Portsmouth
Portsmouth, Virginia 23708

Madigan Army Medical Center
Lakewood, Washington 98431

More Details

NCT ID
NCT04360486
Status
No longer available
Sponsor
U.S. Army Medical Research and Development Command

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.