The Safety and Efficacy of SCTA01 Against COVID-19 in Patients Admitted to High Dependence or Intensive Care

Covid19 Clinical Trial

Official title:

An Adaptive, Randomized, Double-blinded, Placebo-controlled, Phase II/III Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in Patients With Severe COVID-19 Admitted to High Dependence or Intensive Care Unit (MASP3 Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04683328
• Other study ID #: SCTA01-C301
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: February 25, 2021
• Est. completion date: November 25, 2021

Study information

• Verified date: December 2020
• Source: Sinocelltech Ltd.
• Contact: Ji Qi, PhD
• Phone: +86-10-5862 8288
• Email: ji_qi[@]sinocelltech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an adaptive, randomized, double-blinded, placebo-controlled, Phase II/III study conducted to evaluate the effect of SCTA01 on participant survival and clinical efficacy in participants with severe COVID-19 admitted to high dependence or ICUs.

The study duration of subject participation will be up to: 120 days Participants will receive a single intravenous (IV) infusion of SCTA01 at Treatment day 1. Follow up visits will be up to 120 days or early withdrawal visit.

Description:

The study is a multicenter, adaptive, randomized, double-blinded, and placebo-controlled Phase II/III trial. It will be conducted globally. The study will evaluate the efficacy and safety of SCTA01 compared to placebo both given with BSC in participants with severe COVID-19. The subjects will be randomized by 1:1 ratio to SCTA01 and placebo group. The primary objective of the study is to evaluate participant survival from randomization to Day 29 between study group and control group. At the end of the Phase II part of the study, an interim analysis will be performed for safety run-in and futility stopping.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 560
• Est. completion date: November 25, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female of =18years at time of enrollment;

• Subject (or legally authorized representative [LAR]) is able and willing to provide written or verbal informed consent, which includes compliance with study requirements and restrictions listed in the consent form.

• Female subjects must agree to use an approved highly effective birth control (BC) method (<1% failure rate per year) throughout the study (until completion of the Day 85 Follow-up Visit), unless documented to have a reproductive status of non-childbearing potential or is postmenopausal:

1. Non-childbearing potential defined as pre-menopausal female with medical history of bilateral tubal ligation, bilateral oophorectomy (removal of the ovaries), or hysterectomy; hysteroscopic sterilization,

2. Postmenopausal defined as 12 months of spontaneous amenorrhea

• Woman of childbearing potential (WCBP) who is already using an established method of highly effective contraception or agrees to use one of the allowed BC methods listed in the protocol, for at least 28 days prior to the start of dosing (as determined by the Investigator or designee) to sufficiently minimize the risk of pregnancy throughout study participation (until completion of the Day 90 Follow-up Visit).

• Hospitalized participants with severe COVID-19(6-8 point on WHO 10-Point Ordinal Scale):

1. Point 6: Oxygen by NIV or high flow;

2. Point 7: Intubation and MV, pO2/FiO2 = 150 mmHg or SpO2/FiO2 = 200 mmHg;

3. Point 8: MV pO2/FiO2 < 150 mmHg (or SpO2/FiO2 < 200 mmHg) or vasopressors .

• Biological samples (not limited to any specific type) collected within 72 hours (allow retesting for potential subjects that tested positive beyond 72 hours) before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR, etc.);

• = 14 days since the onset of COVID-19 symptoms.

Exclusion Criteria:

• Subject has been intubated for >72 hours. Note: in the event of extubation and re-intubation, the calculation for the number of hours the subject has been intubated begins at the first intubation

• Require or anticipated need for extracorporeal membrane oxygenation (ECMO) Suspected or proven septic shock or shock ;

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is >5 times higher than the upper limit normal range;

• Severe chronic respiratory disease (e.g., known chronic obstructive pulmonary disease [COPD], pulmonary arterial hypertension [PAH], idiopathic pulmonary fibrosis [IPF], interstitial lung disease [ILD]) requiring supplemental oxygen therapy or mechanical ventilation pre-hospitalization (e.g., prior to COVID-19 diagnosis)

• Use of prohibited medications

• Participants with severe COVID-19 who received convalescent plasma or COVID-19 vaccine , or anti-spike (S) SARS-CoV-2 therapy.

• Moribund condition in the opinion of the clinical team

Related Conditions & MeSH terms

• Covid19

Intervention

Biological:
• SCTA01
Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
• SCTA01 Placebo
The excipients of SCTA01

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality rate at D29	The mortality rates in placebo and treatment groups regardless of the cause of death.	Day 29
Secondary	All-cause mortality rate at Day 60	The mortality rates in placebo and treatment groups regardless of the cause of death.	Day 60
Secondary	Time to discontinue mechanical ventilation (MV) at Day 29	The number of days from randomization to discontinue MV support	Baseline through Day 29
Secondary	Time to improvement of two categories on WHO 10-Point Ordinal Scale from baseline at Day 29	The number of days from baseline to two categories decreases on World Health Organization (WHO) 10-Point Ordinal Scale at Day 29.	Baseline through Day 29
Secondary	Time to discontinue supplemental oxygen at Day 29	The number of days from randomization to discontinue supplemental oxygen support	Baseline through Day 29
Secondary	Time to hospital free at Day 29	The number of days from randomization to subject's discharge from hospital.	Baseline through Day 29
Secondary	Change from baseline in viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR)	Change from baseline in viral shedding	Baseline through Day 29
Secondary	SAE	SAEs collected from Day 1 to Day 120	Day 1 through Day 120
Secondary	Anti-drug antibody (ADA)	ADA will be tested at Day 29 and Day120 after SCTA01/placebo administration	Day 29, Day 120