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

NCT04644185 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: SCTA01-B301
• Study Type: interventional
• Target: 102
• Locations: 7 countries
• Sites: 7

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).

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Time to Clinical Improvement up to Day 29

  The median time to clinical improvement in the SCTA01 groups and control group

  Day 29

Study Arms (3)

SCTA01 Low Dose+BSC

EXPERIMENTAL

SCTA01in a lower dose+best supportive care

Drug: SCTA01

SCTA01 High Dose+BSC

EXPERIMENTAL

SCTA01in a higher dose+best supportive care

Drug: SCTA01

Placebo+BSC

ACTIVE COMPARATOR

SCTA01 excipients+best supportive care

Other: Placebo

Interventions

SCTA01 DRUG

SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

Also known as: Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

SCTA01 High Dose+BSC; SCTA01 Low Dose+BSC

Placebo OTHER

all SCTA01 excipients without active component+best supportive care

Also known as: SCTA01 excipients

Placebo+BSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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/ \[SCr (mg/dL) × 72\]}.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (7)

SCT study site

Somers Point, New Jersey, 08244, United States

Location

SCT study site

Buenos Aires, Argentina

Location

SCT study site

Uberlândia, Brazil

Location

SCT study site

Talca, Chile

Location

SCT study site

Rionegro, Colombia

Location

SCT study site

Monterrey, Mexico

Location

SCT study site

Lima, Peru

Location

Related Publications (1)

• 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.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

upanovimab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr.
• Organization: Sinocelltech Ltd.

yuanxin_chen@sinocelltech.com

13522038372

Study Officials

• Zhanghua Lan, PhD

  Sinocelltech Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 25, 2020
• Study Start: March 27, 2021
• Primary Completion: December 29, 2021
• Study Completion: February 11, 2022
• Last Updated: October 24, 2025
• Results First Posted: October 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); US (1); PE (1); CO (1); AR (1); BR (1); CL (1)