NCT04360486.

Study name	Expanded access protocol for the treatment of coronavirus disease 2019 (COVID‐19) with anti‐SARS‐CoV‐2 convalescent plasma (ASCoV2CP)
Methods	Trial design: expanded access open‐label, single‐arm treatment protocol Sample size: NR Setting: Military Treatment Facilities (MTFs) (e.g. hospital ships, field hospitals deployed for the COVID‐19 response) Country: USA Language: English Number of centres: initially 1 with capacity to expand to  multiple sites (number not specified)
Participants	Inclusion criteria: Child, adult, older adult All sexes Department of Defense (DoD) personnel covered by the Force Health Protection (FHP) program under the Department of Defence 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 defence support for civilian authorities (e.g. hospital ships, field hospitals deployed for the COVID‐19 response) Laboratory‐confirmed COVID‐19 diagnosis Severe or life‐threatening COVID‐19 disease, or judged by the subinvestigator (treating physician) to be at high risk for progression to severe or life‐threatening disease Informed consent provided by the patient or LAR, except in situations described in 21 CFR 50.23 Understands and agrees to comply with planned protocol procedures Patient agrees to storage of specimens for future testing Signed an informed consent form Exclusion criteria 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 investigational COVID‐19 treatment, for example: remdesivir, unless the treating physician subinvestigator (treating physician) feels that the patient would be put at risk by receiving multiple investigational therapies
Interventions	Intervention(s): anti‐SARS‐CoV‐2 convalescent plasma Details of CP: Type of plasma: fresh frozen plasma, plasma frozen for 24 h (PF‐24) or liquid plasma Volume: NR Number of doses: NR Antibody‐titre: NR Pathogen inactivated: NR Treatment details, including time of plasma therapy (e.g. early stage of disease): generally reserved for patients at severe risk or at risk of progression to life‐threatening disease. In adults defined as: Dyspnoea Respiratory frequency ≥ 30/min Blood oxygen saturation ≤ 93% Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 Lung infiltrates > 50% within 24‐48 h; i.e. infiltrates increase by > 50% in < 2 days Life‐threatening COVID‐19 is defined as one or more of the following: Respiratory failure Septic shock Multiple organ dysfunction or failure Comparator: N/A Concomitant therapy: NR Treatment cross‐overs: N/A
Outcomes	Primary study outcome(s): efficacy of this treatment will not be evaluated Primary review outcomes reported All‐cause mortality at hospital discharge: NR Time to death: NR Secondary review outcomes reported Number of participants with grade 3 and grade 4 adverse events, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): NR  Number of participants with SAEs: NR Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8 ‐15 days; 16 to 30 days: NR 30‐day and 90‐day mortality: NR Admission on ICU: NR Length of stay on the ICU: NR Time to discharge from hospital: NR Additional outcomes: NR
Starting date	24 April 2020
Contact information	Andrew P Cap, MS, MD, PhD, FACP   andrew.p.cap.mil@mail.mil U.S. Army Medical Research and Development Command
Notes	Recruitment status: expanded access, available Prospective completion date: NR Sponsor/Funding: U.S. Army Medical Research and Development Command