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

Phase 1

Withdrawn

• Conditions: COVID-19
• Interventions: Drug: SCTA01 and SCTA01C; Drug: Placebo

• Registration Number: NCT05156645
• Lead Sponsor: Sinocelltech Ltd.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-14
• Last Update Submitted: 2022-01-11
• Study Start: 2022-01-15
• Last Update Posted: 2022-01-27
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 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;

Exclusion Criteria

• 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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCTA01 and SCTA01C+SOC	SCTA01 and SCTA01C	-
Placebo+SOC	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Time to symptom improvement	Day 29
Mean concentration-time profiles of SCTA01 and SCTA01C	Day 120