Clinical trial NCT04644185: The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19
Official title: A Multicenter, Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in Hospitalized Patients With Severe COVID-19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Covid19
Lead sponsor: Sinocelltech Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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/ \[SCr (mg/dL) × 72\]}.

Primary outcomes:
measure: The clinical efficacy of SCTA01 (Phase II and III)
timeFrame: Day 29
Secondary outcomes:
measure: Cumulative incidence of SAEs(Phase II, III)
timeFrame: 3 Months
measure: Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III)
timeFrame: Day 120
measure: area under the curve (AUC0-t)(Phase II)
timeFrame: Day 120
measure: AUC0-∞(Phase II)
timeFrame: Day 120
measure: Half-life time (t1/2)(Phase II)
timeFrame: Day 120
measure: Maximum concentration (Cmax)(Phase II)
timeFrame: Day 120
measure: Peak time (Tmax)(Phase II)
timeFrame: Day 120
measure: Clearance (CL)(Phase II)
timeFrame: Day 120
measure: Apparent volume of distribution (Vd)(Phase II)
timeFrame: Day 120
measure: Elimination rate constant (λz)(Phase II)
timeFrame: Day 120
measure: Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III)
timeFrame: Day 120
Other outcomes:
Locations:
city: Somers Point
country: United States
facility: SCT study site
state: New Jersey
city: Ciudad Autonoma de Buenos aires
country: Argentina
facility: SCT study site
city: Uberlândia
country: Brazil
facility: SCT study site
city: Talca
country: Chile
facility: SCT study site
city: Rionegro
country: Colombia
facility: SCT study site
city: Monterrey
country: Mexico
facility: SCT study site
city: Lima
country: Peru
facility: SCT study site
Study officials:
affiliation: Sinocelltech Ltd.
name: Zhanghua Lan, PhD
role: STUDY_DIRECTOR
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.