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

COVID-19 Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04709328
• Other study ID #: SCTA01-A301
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: March 28, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2021
• Source: Sinocelltech Ltd.
• Contact: Qiang Guo, PhD
• Phone: 86-10-5862 8288
• Email: qiang_guo[@]sinocelltech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 690
• Est. completion date: March 1, 2022
• Est. primary completion date: January 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 =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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Drug:
• SCTA01
Diluted by 0.9% normal saline,IV

Other:
• Placebo
IV

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.		Day 29
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 admitted to hospital due to COVID-19		Day 29
Secondary	Proportion of participants with =1 COVID-19 related hospitalization		Day 29
Secondary	Proportion of participants with =2 COVID-19 related hospitalizations		Day 29
Secondary	Total number of COVID-19 related hospitalization		Day 29
Secondary	Proportion of participants who experience COVID-19 related emergency room (ER) visit		Day 29
Secondary	Proportion of participants with =1 ER visit due to COVID-19		Day 29
Secondary	Proportion of participants with =2 ER visits due to COVID-19 through Day 29		Day 29
Secondary	Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19		Day 29
Secondary	Proportion of patients with all-cause mortality		Day 29
Secondary	Proportion of participants with O2 requirement		Day 29
Secondary	Proportion of participants with ventilation requirements		Day 29
Secondary	Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples		Day 8, Day 15
Secondary	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.		Day 8, Day 15
Secondary	Cumulative incidence of serious adverse events (SAEs)		Day 120
Secondary	Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)		Day 120
Secondary	Discontinuation or temporary suspension of infusions (for any reason)		Day 120
Secondary	Number and proportion of patients with ADE		Day 120
Secondary	Mean concentration-time profiles of SCTA01		Day 29
Secondary	Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01		Day 1, Day 8, Day 29, and Day 120)