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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Covid19
• Intervention / Treatment: Biological: SCTA01; Biological: SCTA01 Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 560
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SCTA01 Group; SCTA01+Best Supportive Care	Biological: SCTA01; Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
PLACEBO_COMPARATOR: Placebo Group; Placebo+Best Supportive Care	Biological: SCTA01 Placebo; The excipients of SCTA01

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality rate at D29	The mortality rates in placebo and treatment groups regardless of the cause of death.	Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality rate at Day 60	The mortality rates in placebo and treatment groups regardless of the cause of death.	Day 60
Time to discontinue mechanical ventilation (MV) at Day 29	The number of days from randomization to discontinue MV support	Baseline through Day 29
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
Time to discontinue supplemental oxygen at Day 29	The number of days from randomization to discontinue supplemental oxygen support	Baseline through Day 29
Time to hospital free at Day 29	The number of days from randomization to subject's discharge from hospital.	Baseline through Day 29
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
SAE	SAEs collected from Day 1 to Day 120	Day 1 through Day 120
Anti-drug antibody (ADA)	ADA will be tested at Day 29 and Day120 after SCTA01/placebo administration	Day 29, Day 120

Collaborators and Investigators

• Sponsor: Sinocelltech Ltd.
• Investigators: Study Director: Zhanghua Lan, PhD, SCT

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 25, 2021
• Primary Completion (ANTICIPATED): May 25, 2021
• Study Completion (ANTICIPATED): November 25, 2021

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (ACTUAL): December 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 17, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SCTA01-C301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No