The Efficacy and Safety of SCTA01 in Hospitalized Patients With Severe COVID-19

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

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).

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: SCTA01; Other: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 795
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Buenos aires, Argentina
    • Not yet recruiting
    • SCT study site
    • Contact: Marcelo
• Brazil
  • Uberlândia, Brazil
    • Not yet recruiting
    • SCT study site
    • Contact: Arantes
• Chile
  • Talca, Chile
    • Not yet recruiting
    • SCT study site
    • Contact: Silva
• Colombia
  • Rionegro, Colombia
    • Not yet recruiting
    • SCT study site
    • Contact: Gomez
• Mexico
  • Monterrey, Mexico
    • Not yet recruiting
    • SCT study site
    • Contact: Mercado Longoria
• Peru
  • Lima, Peru
    • Not yet recruiting
    • SCT study site
    • Contact: Carbajal
• United States
  • New Jersey
    • Somers Point, New Jersey, United States, 08244
      • Recruiting
      • SCT study site
      • Contact: Lucasti

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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]}.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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: Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
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: Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Active Comparator: Placebo+BSC; SCTA01 excipients+best supportive care	Other: Placebo; all SCTA01 excipients without active component+best supportive care; Other Names: SCTA01 excipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinical efficacy of SCTA01 (Phase II and III)	As assessed by time to clinical improvement (TTCI)	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of SAEs(Phase II, III)	Cumulative incidence of serious adverse events in both Phase II and III	3 Months
Change from baseline in viral shedding as measured by RT-qPCR(Phase II and III)	Change from baseline in viral shedding as measured by RT-qPCR in NP swab samples	Day 120
area under the curve (AUC0-t)(Phase II)	AUC0-t through Day 120	Day 120
AUC0-∞(Phase II)	AUC0-∞ through Day 120	Day 120
Half-life time (t1/2)(Phase II)	t1/2 through Day 120	Day 120
Maximum concentration (Cmax)(Phase II)	Cmax through Day 120	Day 120
Peak time (Tmax)(Phase II)	Tmax through Day 120	Day 120
Clearance (CL)(Phase II)	CL through Day 120	Day 120
Apparent volume of distribution (Vd)(Phase II)	Vd through Day 120	Day 120
Elimination rate constant (λz)(Phase II)	λz through Day 120	Day 120
Immunogenicity as measured by anti-drug antibodies (ADA) (Phase II, III)	ADA against SCTA01 at baseline and Day 120	Day 120

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.
• Investigators: Study Director: Zhanghua Lan, PhD, Sinocelltech Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2021
• Primary Completion (Anticipated): June 27, 2021
• Study Completion (Anticipated): December 27, 2021

Study Registration Dates

• First Submitted: November 22, 2020
• First Submitted That Met QC Criteria: November 24, 2020
• First Posted (Actual): November 25, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Myeloma Proteins; Paraproteins
• Other Study ID Numbers: SCTA01-B301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No