The Safety and Efficacy of SCTA01 Against COVID-19 in Patients Admitted to High Dependence or Intensive Care

Inclusion Criteria:

- Male and female of ≥18years at time of enrollment;

- Subject (or legally authorized representative [LAR]) is able and willing to provide
written or verbal informed consent, which includes compliance with study requirements
and restrictions listed in the consent form.

- Female subjects must agree to use an approved highly effective birth control (BC)
method (<1% failure rate per year) throughout the study (until completion of the Day
85 Follow-up Visit), unless documented to have a reproductive status of
non-childbearing potential or is postmenopausal:

1. Non-childbearing potential defined as pre-menopausal female with medical history
of bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or
hysterectomy; hysteroscopic sterilization,

2. Postmenopausal defined as 12 months of spontaneous amenorrhea

- Woman of childbearing potential (WCBP) who is already using an established method of
highly effective contraception or agrees to use one of the allowed BC methods listed
in the protocol, for at least 28 days prior to the start of dosing (as determined by
the Investigator or designee) to sufficiently minimize the risk of pregnancy
throughout study participation (until completion of the Day 90 Follow-up Visit).

- Hospitalized participants with severe COVID-19（6-8 point on WHO 10-Point Ordinal
Scale):

1. Point 6: Oxygen by NIV or high flow;

2. Point 7: Intubation and MV, pO2/FiO2 ≥ 150 mmHg or SpO2/FiO2 ≥ 200 mmHg;

3. Point 8: MV pO2/FiO2 < 150 mmHg (or SpO2/FiO2 < 200 mmHg) or vasopressors .

- Biological samples (not limited to any specific type) collected within 72 hours (allow
retesting for potential subjects that tested positive beyond 72 hours) before
randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR, etc.);

- ≤ 14 days since the onset of COVID-19 symptoms.

Exclusion Criteria:

- Subject has been intubated for >72 hours. Note: in the event of extubation and
re-intubation, the calculation for the number of hours the subject has been intubated
begins at the first intubation

- Require or anticipated need for extracorporeal membrane oxygenation (ECMO) Suspected
or proven septic shock or shock ;

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is >5 times higher
than the upper limit normal range;

- Severe chronic respiratory disease (e.g., known chronic obstructive pulmonary disease
[COPD], pulmonary arterial hypertension [PAH], idiopathic pulmonary fibrosis [IPF],
interstitial lung disease [ILD]) requiring supplemental oxygen therapy or mechanical
ventilation pre-hospitalization (e.g., prior to COVID-19 diagnosis)

- Use of prohibited medications

- Participants with severe COVID-19 who received convalescent plasma or COVID-19 vaccine
, or anti-spike (S) SARS-CoV-2 therapy.

- Moribund condition in the opinion of the clinical team