Treatment Of CORONAVIRUS DISEASE 2019 (COVID-19) With Anti-Sars-CoV-2 Convalescent Plasma (ASCoV2CP)

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.