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Covid19Phase 2/3NCT04683328

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

A Phase 2/3 study testing SCTA01 in people with Covid19, run by Sinocelltech Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
SCTA01
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
560 participants
Where
No sites listed yet
Study dates
25 Feb 2021to 25 Nov 2021
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Ji Qi, PhD contact

+86-10-5862 8288 ext. 9360

ji_qi@sinocelltech.com

About this study

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)

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.

Read the 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.

Conditions
Covid19
Being tested
SCTA01, SCTA01 Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCTA01Biological

    Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody

  • SCTA01 PlaceboBiological

    The excipients of SCTA01

Study groups in NCT04683328
Study groupRoleWhat they receive
SCTA01 GroupExperimentalSCTA01+Best Supportive Care
Receives: Biological: SCTA01
Placebo GroupPlacebo comparatorPlacebo+Best Supportive Care
Receives: Biological: SCTA01 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality rate at D29

    The mortality rates in placebo and treatment groups regardless of the cause of death.

    Measured: Day 29

Secondary outcomes (8)

  1. All-cause mortality rate at Day 60

    The mortality rates in placebo and treatment groups regardless of the cause of death.

    Measured: Day 60

  2. Time to discontinue mechanical ventilation (MV) at Day 29

    The number of days from randomization to discontinue MV support

    Measured: Baseline through Day 29

  3. 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.

    Measured: Baseline through Day 29

  4. Time to discontinue supplemental oxygen at Day 29

    The number of days from randomization to discontinue supplemental oxygen support

    Measured: Baseline through Day 29

  5. Time to hospital free at Day 29

    The number of days from randomization to subject's discharge from hospital.

    Measured: Baseline through Day 29

  6. Change from baseline in viral shedding as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR)

    Change from baseline in viral shedding

    Measured: Baseline through Day 29

  7. SAE

    SAEs collected from Day 1 to Day 120

    Measured: Day 1 through Day 120

  8. Anti-drug antibody (ADA)

    ADA will be tested at Day 29 and Day120 after SCTA01/placebo administration

    Measured: Day 29, Day 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2020
  2. Study start25 Feb 2021 (estimated)
  3. Primary completion25 May 2021 (estimated)
  4. Study completion25 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
SCTA01+BSC vs Placebo+BSC
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
560 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04683328
Sponsor's protocol ID
SCTA01-C301
Status last verified
Dec 2020
First submitted
20 Dec 2020
Last updated
20 Jan 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34473343

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SCTA01 in people with Covid19, run by Sinocelltech Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ji Qi, PhD (+86-10-5862 8288 ext. 9360, ji_qi@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality rate at D29 (time frame: Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04683328, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.

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