A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SCTA01 and SCTA01C
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SCTA01 and SCTA01C+SOC
Placebo+SOC
Arm Description
Outcomes
Primary Outcome Measures
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)
Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)
Secondary Outcome Measures
Time to sustained resolution of all COVID-19-related symptoms
Change in symptom score (total of ratings)
Time to symptom improvement
Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples
Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody
Mean concentration-time profiles of SCTA01 and SCTA01C
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05156645
Brief Title
A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Withdrawn
Why Stopped
The study was withdraw due to the fast spread of Omicron variant worldwide
Study Start Date
January 15, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinocelltech Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCTA01 and SCTA01C+SOC
Arm Type
Experimental
Arm Title
Placebo+SOC
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SCTA01 and SCTA01C
Intervention Description
Diluted by 0.9% normal saline
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Diluted by 0.9% normal saline
Primary Outcome Measure Information:
Title
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)
Time Frame
Day 29
Title
Proportion of patients with ≥Grade 3 treatment related adverse event (TRAE) up to Day 8 (Phase I/II)
Time Frame
Day 8
Secondary Outcome Measure Information:
Title
Time to sustained resolution of all COVID-19-related symptoms
Time Frame
Day 29
Title
Change in symptom score (total of ratings)
Time Frame
Day 3, 5, 7, 11, 15, 22, and 29
Title
Time to symptom improvement
Time Frame
Day 29
Title
Proportion of participants that achieve SARS-CoV-2 clearance in NP or OP samples
Time Frame
Day 29
Title
Immunogenicity assessment includes the number and percentage of patients who develop detectable anti drug antibody
Time Frame
Day 120
Title
Mean concentration-time profiles of SCTA01 and SCTA01C
Time Frame
Day 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Study to Evaluate Efficacy and Safety of the Combination of SCTA01 & SCTA01C in Outpatients With COVID-19
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