The Safety and Efficacy of SCTA01 Against COVID-19 in Patients Admitted to High Dependence or Intensive Care
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCTA01
SCTA01 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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:
- 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,
- 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):
- Point 6: Oxygen by NIV or high flow;
- Point 7: Intubation and MV, pO2/FiO2 ≥ 150 mmHg or SpO2/FiO2 ≥ 200 mmHg;
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SCTA01 Group
Placebo Group
Arm Description
SCTA01+Best Supportive Care
Placebo+Best Supportive Care
Outcomes
Primary Outcome Measures
All-cause mortality rate at D29
The mortality rates in placebo and treatment groups regardless of the cause of death.
Secondary Outcome Measures
All-cause mortality rate at Day 60
The mortality rates in placebo and treatment groups regardless of the cause of death.
Time to discontinue mechanical ventilation (MV) at Day 29
The number of days from randomization to discontinue MV support
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.
Time to discontinue supplemental oxygen at Day 29
The number of days from randomization to discontinue supplemental oxygen support
Time to hospital free at Day 29
The number of days from randomization to subject's discharge from hospital.
Change from baseline in viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR)
Change from baseline in viral shedding
SAE
SAEs collected from Day 1 to Day 120
Anti-drug antibody (ADA)
ADA will be tested at Day 29 and Day120 after SCTA01/placebo administration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04683328
Brief Title
The Safety and Efficacy of SCTA01 Against COVID-19 in Patients Admitted to High Dependence or Intensive Care
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)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2021 (Anticipated)
Primary Completion Date
May 25, 2021 (Anticipated)
Study Completion Date
November 25, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SCTA01+BSC vs Placebo+BSC
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
560 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SCTA01 Group
Arm Type
Experimental
Arm Description
SCTA01+Best Supportive Care
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Placebo+Best Supportive Care
Intervention Type
Biological
Intervention Name(s)
SCTA01
Intervention Description
Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Intervention Type
Biological
Intervention Name(s)
SCTA01 Placebo
Intervention Description
The excipients of SCTA01
Primary Outcome Measure Information:
Title
All-cause mortality rate at D29
Description
The mortality rates in placebo and treatment groups regardless of the cause of death.
Time Frame
Day 29
Secondary Outcome Measure Information:
Title
All-cause mortality rate at Day 60
Description
The mortality rates in placebo and treatment groups regardless of the cause of death.
Time Frame
Day 60
Title
Time to discontinue mechanical ventilation (MV) at Day 29
Description
The number of days from randomization to discontinue MV support
Time Frame
Baseline through Day 29
Title
Time to improvement of two categories on WHO 10-Point Ordinal Scale from baseline at Day 29
Description
The number of days from baseline to two categories decreases on World Health Organization (WHO) 10-Point Ordinal Scale at Day 29.
Time Frame
Baseline through Day 29
Title
Time to discontinue supplemental oxygen at Day 29
Description
The number of days from randomization to discontinue supplemental oxygen support
Time Frame
Baseline through Day 29
Title
Time to hospital free at Day 29
Description
The number of days from randomization to subject's discharge from hospital.
Time Frame
Baseline through Day 29
Title
Change from baseline in viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR)
Description
Change from baseline in viral shedding
Time Frame
Baseline through Day 29
Title
SAE
Description
SAEs collected from Day 1 to Day 120
Time Frame
Day 1 through Day 120
Title
Anti-drug antibody (ADA)
Description
ADA will be tested at Day 29 and Day120 after SCTA01/placebo administration
Time Frame
Day 29, Day 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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,
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):
Point 6: Oxygen by NIV or high flow;
Point 7: Intubation and MV, pO2/FiO2 ≥ 150 mmHg or SpO2/FiO2 ≥ 200 mmHg;
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Qi, PhD
Phone
+86-10-5862 8288
Ext
9360
Email
ji_qi@sinocelltech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhanghua Lan, PhD
Organizational Affiliation
SCT
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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
derived
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The Safety and Efficacy of SCTA01 Against COVID-19 in Patients Admitted to High Dependence or Intensive Care
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