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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Withdrawn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

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT05156645

First Posted

December 9, 2021

Last Updated

January 11, 2022

Sponsor

Sinocelltech Ltd.

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

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

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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