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To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19 (MAOP3)

Primary Purpose

COVID-19, SARS-CoV-2

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

SCTA01

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 ≤7 days before randomization;
First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤3 days prior to start of the infusion;
Participants are currently not hospitalized;
Participant (or legal authorized representative) has signed the ICF before any clinical activity related to SCTA01 trial;
Women with childbearing potential must agree to use effective contraceptive methods during the study period;
Patient should not participate in other clinical studies related to COVID-19 or SARS-CoV-2 infection.

Exclusion Criteria:

Have known allergies to any of the components used in the formulation of the SCTA01/placebo;
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;
Have any co-morbidity requiring surgery within <29 days, or that is considered life threatening within 29 days;
Have a history of previous SARS-CoV-2 infection;
Received convalescent plasma, COVID-19 vaccine, or anti-SARS-CoV-2 spike(S) protein targeted therapy;
Have participated in a clinical study involving an investigational intervention within past 30 days or 5-half lives of investigational product, whichever is longer;
Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing;
Pregnant or lactating women;
Anticipated hospitalization or transfer to another medical site which is not a study site within 72 hours;
Participants unable to follow the protocol during the study;
Participants deemed inappropriate for enrollment by the investigator due to other factors.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

SCTA01 low dose +SOC

SCTA01 middle dose+SOC

SCTA01 High dose +SOC

Placebo+SOC

Arm Description

SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

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.

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 admitted to hospital due to COVID-19

Proportion of participants with ≥1 COVID-19 related hospitalization

Proportion of participants with ≥2 COVID-19 related hospitalizations

Total number of COVID-19 related hospitalization

Proportion of participants who experience COVID-19 related emergency room (ER) visit

Proportion of participants with ≥1 ER visit due to COVID-19

Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29

Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19

Proportion of patients with all-cause mortality

Proportion of participants with O2 requirement

Proportion of participants with ventilation requirements

Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples

Change from baseline (Day 1) to Day 8 or Day 15 in SARS-CoV-2 viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in NP or OP samples for SARS-CoV-2 test.

Cumulative incidence of serious adverse events (SAEs)

Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)

Discontinuation or temporary suspension of infusions (for any reason)

Number and proportion of patients with ADE

Mean concentration-time profiles of SCTA01

Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01

Full Information

NCT ID

NCT04709328

First Posted

January 13, 2021

Last Updated

March 24, 2021

Sponsor

Sinocelltech Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04709328

Brief Title

To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19

Acronym

MAOP3

Official Title

An Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19 (MAOP3 Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 28, 2021 (Anticipated)

Primary Completion Date

January 1, 2022 (Anticipated)

Study Completion Date

March 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 a multicenter, adaptive, randomized, double-blinded and placebo-controlled Phase II/III clinical trial. It will be conducted at selected investigational sites globally. The study is comprised of 2 parts.

Detailed Description

The study is a multicenter, adaptive, randomized, double-blinded, and placebocontrolled Phase II/III trial. It will be conducted globally. The study will evaluate the efficacy and safety of SCTA01 in high-risk outpatients with COVID-19.The primary objective of the study is to evaluate the clinical efficacy rate among study group [SCTA01+ standard of care (SOC)] and control group (placebo + SOC) up to Day 29.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, SARS-CoV-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

690 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SCTA01 low dose +SOC

Arm Type

Experimental

Arm Description

SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

Arm Title

SCTA01 middle dose+SOC

Arm Type

Experimental

Arm Description

SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

Arm Title

SCTA01 High dose +SOC

Arm Type

Experimental

Arm Description

SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

Arm Title

Placebo+SOC

Arm Type

Placebo Comparator

Arm Description

SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

Intervention Type

Drug

Intervention Name(s)

SCTA01

Intervention Description

Diluted by 0.9% normal saline，IV

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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.

Time Frame

Day 29

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 admitted to hospital due to COVID-19

Time Frame

Day 29

Title

Proportion of participants with ≥1 COVID-19 related hospitalization

Time Frame

Day 29

Title

Proportion of participants with ≥2 COVID-19 related hospitalizations

Time Frame

Day 29

Title

Total number of COVID-19 related hospitalization

Time Frame

Day 29

Title

Proportion of participants who experience COVID-19 related emergency room (ER) visit

Time Frame

Day 29

Title

Proportion of participants with ≥1 ER visit due to COVID-19

Time Frame

Day 29

Title

Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29

Time Frame

Day 29

Title

Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19

Time Frame

Day 29

Title

Proportion of patients with all-cause mortality

Time Frame

Day 29

Title

Proportion of participants with O2 requirement

Time Frame

Day 29

Title

Proportion of participants with ventilation requirements

Time Frame

Day 29

Title

Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples

Time Frame

Day 8, Day 15

Title

Time Frame

Day 8, Day 15

Title

Cumulative incidence of serious adverse events (SAEs)

Time Frame

Day 120

Title

Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)

Time Frame

Day 120

Title

Discontinuation or temporary suspension of infusions (for any reason)

Time Frame

Day 120

Title

Number and proportion of patients with ADE

Time Frame

Day 120

Title

Mean concentration-time profiles of SCTA01

Time Frame

Day 29

Title

Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01

Time Frame

Day 1, Day 8, Day 29, and 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 ≤7 days before randomization; First positive SARS-CoV-2 viral infection tested (PCR or antigen-based diagnostic tests) in samples collected ≤3 days prior to start of the infusion; Participants are currently not hospitalized; Participant (or legal authorized representative) has signed the ICF before any clinical activity related to SCTA01 trial; Women with childbearing potential must agree to use effective contraceptive methods during the study period; Patient should not participate in other clinical studies related to COVID-19 or SARS-CoV-2 infection. Exclusion Criteria: Have known allergies to any of the components used in the formulation of the SCTA01/placebo; 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; Have any co-morbidity requiring surgery within <29 days, or that is considered life threatening within 29 days; Have a history of previous SARS-CoV-2 infection; Received convalescent plasma, COVID-19 vaccine, or anti-SARS-CoV-2 spike(S) protein targeted therapy; Have participated in a clinical study involving an investigational intervention within past 30 days or 5-half lives of investigational product, whichever is longer; Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing; Pregnant or lactating women; Anticipated hospitalization or transfer to another medical site which is not a study site within 72 hours; Participants unable to follow the protocol during the study; Participants deemed inappropriate for enrollment by the investigator due to other factors.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qiang Guo, PhD

Phone

86-10-5862 8288

qiang_guo@sinocelltech.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhanghua Lan, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

34473343

Citation

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Results Reference

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To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19

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