Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)
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
- Severe Acute Respiratory Syndrome Coronavirus 2
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- 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
Oceanside 5378771, California 5332921 92055
San Diego 5391811, California 5332921 92134
San Diego 5391811, California 5332921 92136
San Diego 5391811, California 5332921 92136
San Diego 5391811, California 5332921 92136
San Diego 5391811, California 5332921 92136
San Diego 5391811, California 5332921 92136
San Diego 5391811, California 5332921 92136
Fort Carson 5422140, Colorado 5417618 80913
Eglin Air Force Base 7259720, Florida 4155751 32542
Jacksonville 4160021, Florida 4155751 32214
Fort Benning 4195789, Georgia 4197000 31905
Fort Gordon 4195817, Georgia 4197000 30905
Honolulu 5856195, Hawaii 5855797 96859
Biloxi 4418478, Mississippi 4436296 39534
Las Vegas 5506956, Nevada 5509151 89191
Marine Corps Base Camp Lejeune 7267550, North Carolina 4482348 28547
Wright-Patterson Air Force Base 7267761, Ohio 5165418 45433
El Paso 5520993, Texas 4736286 79920
Fort Sam Houston 7267736, Texas 4736286 78234
Fort Belvoir 7257902, Virginia 6254928 22060
Norfolk 4776222, Virginia 6254928 23511
Norfolk 4776222, Virginia 6254928 23511
Norfolk 4776222, Virginia 6254928 23511
Portsmouth 4779999, Virginia 6254928 23708
Lakewood 5800420, Washington 5815135 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).