A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19

NCT05156645 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: SCTA01/SCTA01C-A301
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is comprised of two parts: safety evaluation part (Phase I/II) and the pivotal study (Phase III) to evaluate the efficacy and safety of the combination of SCTA01 \& SCTA01C compared to placebo in addition to Standard of Care (SOC).

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 (Phase III)

  Day 29

• Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)

  Day 8

Secondary Outcomes (6)

• 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 that achieve SARS-CoV-2 clearance in NP or OP samples

  Day 29

• Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody

  Day 120

Study Arms (2)

SCTA01 and SCTA01C+SOC

EXPERIMENTAL

Drug: SCTA01 and SCTA01C

Placebo+SOC

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SCTA01 and SCTA01C DRUG

Diluted by 0.9% normal saline

SCTA01 and SCTA01C+SOC

Placebo DRUG

Diluted by 0.9% normal saline

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 ≤10 days before randomization;
• First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤5 days prior to start of the infusion;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

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

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: December 9, 2021
• First Posted: December 14, 2021
• Study Start: January 15, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 27, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share