The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19

Inclusion Criteria:

- Hospitalized patients with severe COVID-19 (5 point on NIH 8-point ordinal scale).

- Male or female adult ≥18 years of age at time of enrollment;

- Biological samples (not limited to any specific type) collected within 72 hours before
randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based
diagnostic tests);

- ≤ 10 days since symptoms of COVID-19 onset.

Exclusion Criteria:

- Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the
8-point ordinal scale);

- Patients with critical COVID-19;

- Patients with Severe COVID-19 who received convalescent plasma or COVID-19 vaccine, or
anti-SARS-CoV-2 spike (S) protein targeted therapy;

- Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than
the upper limit of the normal value;

- Estimated glomerular filtration rate (eGFR) <30 mL/min or on dialysis {eGFR calculated
by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = [(140 - age) ×
weight (kg)] × 1/ [SCr (mg/dL) × 72]; Female: CrCL (mL/min) = [(140 - age) × weight
(kg)] × 0.85/ [SCr (mg/dL) × 72]}.