COVID-19
Conditions
Brief summary
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).
Interventions
DRUGSCTA01 and SCTA01C
Diluted by 0.9% normal saline
DRUGPlacebo
Diluted by 0.9% normal saline
Sponsors
Sinocelltech Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant female adults, ≥18 years old of age at the time of randomization; * Participants should have at least one of COVID-19 risk factor; * Participants should have at least 2 COVID-19 related symptoms; * Has symptoms consistent with COVID-19 as determined by the investigator with onset ≤10 days before randomization; * First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion;
Exclusion criteria
* Participants with a history of severe anaphylaxis, such as severe anaphylactic reaction, urticaria, and angioedema; * Have SpO2 ≤ 93% on room air at sea level or PaO2/FiO2 \< 300, respiratory rate ≥30 per minute, heart rate ≥125 per minute (FDA); * Require mechanical ventilation or anticipated impending need for mechanical ventilation; * Suspected or proven serious bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking part in this study; * Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | Day 29 |
| Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II) | Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Time to symptom improvement | Day 29 |
| Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples | Day 29 |
| Time to sustained resolution of all COVID-19-related symptoms | Day 29 |
| Mean concentration-time profiles of SCTA01 and SCTA01C | Day 120 |
| Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody | Day 120 |
| Change in symptom score (total of ratings) | Day 3, 5, 7, 11, 15, 22, and 29 |
Outcome results
None listed