The study is comprised of two parts: safety evaluation part (Phase I/II) and the pivotal study (Phase III) to evaluate the efficacy and safety of the combination of SCTA01 \& SCTA01C compared to placebo in addition to Standard of Care (SOC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Diluted by 0.9% normal saline
Diluted by 0.9% normal saline
Proportion of participants who experience COVID-19 related hospitalization (defined as at least 24 hours of acute care) or death (all cause) up to Day 29 (Phase III)
Time frame: Day 29
Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)
Time frame: Day 8
Time to sustained resolution of all COVID-19-related symptoms
Time frame: Day 29
Change in symptom score (total of ratings)
Time frame: Day 3, 5, 7, 11, 15, 22, and 29
Time to symptom improvement
Time frame: Day 29
Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples
Time frame: Day 29
Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody
Time frame: Day 120
Mean concentration-time profiles of SCTA01 and SCTA01C
Time frame: Day 120
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