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

COVID-19 Clinical Trial

Official title:

An Adaptive Phase I/II/III Trial to Evaluate the Efficacy and Safety of Anti-SARS-CoV-2 Monoclonal Antibody Combination (SCTA01C and SCTA01) for Treatment of Outpatients With COVID-19

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05156645
• Other study ID #: SCTA01/SCTA01C-A301
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: January 15, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2021
• Source: Sinocelltech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• SCTA01 and SCTA01C
Diluted by 0.9% normal saline
• Placebo
Diluted by 0.9% normal saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of patients with =Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)		Day 8
Secondary	Time to sustained resolution of all COVID-19-related symptoms		Day 29
Secondary	Change in symptom score (total of ratings)		Day 3, 5, 7, 11, 15, 22, and 29
Secondary	Time to symptom improvement		Day 29
Secondary	Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples		Day 29
Secondary	Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody		Day 120
Secondary	Mean concentration-time profiles of SCTA01 and SCTA01C		Day 120