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

March 24, 2021 updated by: Sinocelltech Ltd.

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
690

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Zhanghua Lan, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SCTA01 low dose +SOC
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Drug: SCTA01
Diluted by 0.9% normal saline，IV
Experimental: SCTA01 middle dose+SOC
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Drug: SCTA01
Diluted by 0.9% normal saline，IV
Experimental: SCTA01 High dose +SOC
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Drug: SCTA01
Diluted by 0.9% normal saline，IV
Placebo Comparator: Placebo+SOC
SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Other: Placebo
IV

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to sustained resolution of all COVID-19-related symptoms
Time Frame: Day 29
Day 29
- Change in symptom score (total of ratings)
Time Frame: Day 3, 5, 7, 11, 15, 22, and 29
Day 3, 5, 7, 11, 15, 22, and 29
Time to symptom improvement;
Time Frame: Day 29
Day 29
Proportion of participants admitted to hospital due to COVID-19
Time Frame: Day 29
Day 29
Proportion of participants with ≥1 COVID-19 related hospitalization
Time Frame: Day 29
Day 29
Proportion of participants with ≥2 COVID-19 related hospitalizations
Time Frame: Day 29
Day 29
Total number of COVID-19 related hospitalization
Time Frame: Day 29
Day 29
Proportion of participants who experience COVID-19 related emergency room (ER) visit
Time Frame: Day 29
Day 29
Proportion of participants with ≥1 ER visit due to COVID-19
Time Frame: Day 29
Day 29
Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29
Time Frame: Day 29
Day 29
Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19
Time Frame: Day 29
Day 29
Proportion of patients with all-cause mortality
Time Frame: Day 29
Day 29
Proportion of participants with O2 requirement
Time Frame: Day 29
Day 29
Proportion of participants with ventilation requirements
Time Frame: Day 29
Day 29
Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples
Time Frame: Day 8, Day 15
Day 8, Day 15
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.
Time Frame: Day 8, Day 15
Day 8, Day 15
Cumulative incidence of serious adverse events (SAEs)
Time Frame: Day 120
Day 120
Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)
Time Frame: Day 120
Day 120
Discontinuation or temporary suspension of infusions (for any reason)
Time Frame: Day 120
Day 120
Number and proportion of patients with ADE
Time Frame: Day 120
Day 120
Mean concentration-time profiles of SCTA01
Time Frame: Day 29
Day 29
Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01
Time Frame: Day 1, Day 8, Day 29, and Day 120)
Day 1, Day 8, Day 29, and Day 120)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinocelltech Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 28, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCTA01-A301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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