The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.
The study is a multicenter, adaptive, randomized, double-blinded, and placebocontrolled Phase II/III trial. It will be conducted globally. The study will evaluate the efficacy and safety of SCTA01 in high-risk outpatients with COVID-19.The primary objective of the study is to evaluate the clinical efficacy rate among study group \[SCTA01+ standard of care (SOC)\] and control group (placebo + SOC) up to Day 29.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
690
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.
Time frame: Day 29
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 admitted to hospital due to COVID-19
Time frame: Day 29
Proportion of participants with ≥1 COVID-19 related hospitalization
Time frame: Day 29
Proportion of participants with ≥2 COVID-19 related hospitalizations
Time frame: Day 29
Total number of COVID-19 related hospitalization
Time frame: Day 29
Proportion of participants who experience COVID-19 related emergency room (ER) visit
Time frame: Day 29
Proportion of participants with ≥1 ER visit due to COVID-19
Time frame: Day 29
Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29
Time frame: Day 29
Zhanghua Lan, PhD
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Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19
Time frame: Day 29
Proportion of patients with all-cause mortality
Time frame: Day 29
Proportion of participants with O2 requirement
Time frame: Day 29
Proportion of participants with ventilation requirements
Time frame: Day 29
Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples
Time frame: Day 8, Day 15
Change from baseline (Day 1) to Day 8 or Day 15 in SARS-CoV-2 viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in NP or OP samples for SARS-CoV-2 test.
Time frame: Day 8, Day 15
Cumulative incidence of serious adverse events (SAEs)
Time frame: Day 120
Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)
Time frame: Day 120
Discontinuation or temporary suspension of infusions (for any reason)
Time frame: Day 120
Number and proportion of patients with ADE
Time frame: Day 120
Mean concentration-time profiles of SCTA01
Time frame: Day 29
Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01
Time frame: Day 1, Day 8, Day 29, and Day 120)