To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19

NCT04709328 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SCTA01-A301
• Study Type: interventional
• Target: 690
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.

Conditions

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 29

Secondary Outcomes (22)

• Time to sustained resolution of all COVID-19-related symptoms

  Day 29

• - Change in symptom score (total of ratings)

  Day 3, 5, 7, 11, 15, 22, and 29

• Time to symptom improvement;

  Day 29

• Proportion of participants admitted to hospital due to COVID-19

  Day 29

• Proportion of participants with ≥1 COVID-19 related hospitalization

  Day 29

Study Arms (4)

SCTA01 low dose +SOC

EXPERIMENTAL

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

Drug: SCTA01

SCTA01 middle dose+SOC

EXPERIMENTAL

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

Drug: SCTA01

SCTA01 High dose +SOC

EXPERIMENTAL

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

Drug: SCTA01

Placebo+SOC

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

SCTA01 DRUG

Diluted by 0.9% normal saline，IV

SCTA01 High dose +SOC; SCTA01 low dose +SOC; SCTA01 middle dose+SOC

Placebo OTHER

IV

Placebo+SOC

Eligibility Criteria

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

You may qualify if:

• 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 ≤7 days before randomization;
• First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤3 days prior to start of the infusion;
• Participants are currently not hospitalized;
• Participant (or legal authorized representative) has signed the ICF before any clinical activity related to SCTA01 trial;
• Women with childbearing potential must agree to use effective contraceptive methods during the study period;
• Patient should not participate in other clinical studies related to COVID-19 or SARS-CoV-2 infection.

You may not qualify if:

• Have known allergies to any of the components used in the formulation of the SCTA01/placebo;
• 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;
• Have any co-morbidity requiring surgery within \<29 days, or that is considered life threatening within 29 days;
• Have a history of previous SARS-CoV-2 infection;
• Received convalescent plasma, COVID-19 vaccine, or anti-SARS-CoV-2 spike(S) protein targeted therapy;
• Have participated in a clinical study involving an investigational intervention within past 30 days or 5-half lives of investigational product, whichever is longer;
• Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing;
• Pregnant or lactating women;
• Anticipated hospitalization or transfer to another medical site which is not a study site within 72 hours;
• Participants unable to follow the protocol during the study;
• Participants deemed inappropriate for enrollment by the investigator due to other factors.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Related Publications (2)

• Diaz J, Fonseca A, Yan L, Liu D, Xie L. Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial. Contemp Clin Trials Commun. 2025 May 17;45:101496. doi: 10.1016/j.conctc.2025.101496. eCollection 2025 Jun.

  PMID: 40520909 DERIVED

• 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

Central Study Contacts

Qiang Guo, PhD

CONTACT

86-10-5862 8288; qiang_guo@sinocelltech.com

Zhanghua Lan, PhD

CONTACT

Study Design

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

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 14, 2021
• Study Start: March 28, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 29, 2021

Record last verified: 2021-03