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Withdrawn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• Status: WITHDRAWN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
Mean concentration-time profiles of SCTA01 and SCTA01C	Day 120
Time to symptom improvement	Day 29