The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19
Study Details
Study Description
Brief Summary
The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III trial, and will be conducted globally. The study is comprised of two parts: dose selection (Phase II) and pivotal treatment effect (Phase III).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Detailed Description
In this study, Phase II part will evaluate the efficacy, safety and PK of SCTA01 low dose+BSC, high dose+BSC and placebo+BSC in patients with severe COVID-19.
In Phase II part, subjects will be randomized at 1:1:1 ratio. At the end of Phase II part, a dose for the Phase III will be determined.
The Phase III part will evaluate the efficacy, safety, and immunogenicity of SCTA01 at the recommended dose recommended. Subjects in Phase III part will be randomized at 1:1 ratio to SCTA01+BSC and placebo+BSC groups.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SCTA01 Low Dose+BSC SCTA01in a lower dose+best supportive care |
Drug: SCTA01
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Other Names:
|
| Experimental: SCTA01 High Dose+BSC SCTA01in a higher dose+best supportive care |
Drug: SCTA01
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Other Names:
|
| Active Comparator: Placebo+BSC SCTA01 excipients+best supportive care |
Other: Placebo
all SCTA01 excipients without active component+best supportive care
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The clinical efficacy of SCTA01 (Phase II and III) [Day 29]
As assessed by time to clinical improvement (TTCI)
Secondary Outcome Measures
- Cumulative incidence of SAEs(Phase II, III) [3 Months]
Cumulative incidence of serious adverse events in both Phase II and III
- Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III) [Day 120]
Change from baseline in viral shedding as measured by RT-qPCR in NP swab samples
- area under the curve (AUC0-t)(Phase II) [Day 120]
AUC0-t through Day 120
- AUC0-∞(Phase II) [Day 120]
AUC0-∞ through Day 120
- Half-life time (t1/2)(Phase II) [Day 120]
t1/2 through Day 120
- Maximum concentration (Cmax)(Phase II) [Day 120]
Cmax through Day 120
- Peak time (Tmax)(Phase II) [Day 120]
Tmax through Day 120
- Clearance (CL)(Phase II) [Day 120]
CL through Day 120
- Apparent volume of distribution (Vd)(Phase II) [Day 120]
Vd through Day 120
- Elimination rate constant (λz)(Phase II) [Day 120]
λz through Day 120
- Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III) [Day 120]
ADA against SCTA01 at baseline and Day 120
Eligibility Criteria
Criteria
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]}.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SCT study site | Somers Point | New Jersey | United States | 08244 |
| 2 | SCT study site | Ciudad Autonoma de Buenos aires | Argentina | ||
| 3 | SCT study site | Uberlândia | Brazil | ||
| 4 | SCT study site | Talca | Chile | ||
| 5 | SCT study site | Rionegro | Colombia | ||
| 6 | SCT study site | Monterrey | Mexico | ||
| 7 | SCT study site | Lima | Peru |
Sponsors and Collaborators
- Sinocelltech Ltd.
Investigators
- Study Director: Zhanghua Lan, PhD, Sinocelltech Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCTA01-B301