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COVID-19Phase 2/3MAOP3NCT04709328

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

A Phase 2/3 study testing SCTA01 in people with COVID-19 and SARS-CoV-2, run by Sinocelltech Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, SARS-CoV-2
What is being tested?
SCTA01
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
690 participants
Where
No sites listed yet
Study dates
28 Mar 2021to 1 Mar 2022
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

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 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Qiang Guo, PhD contact

86-10-5862 8288

qiang_guo@sinocelltech.com

Zhanghua Lan, PhD contact

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 High-Risk Outpatients With COVID-19 (MAOP3 Trial)

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.

Read the detailed 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.

Conditions
COVID-19, SARS-CoV-2
Being tested
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.

  • SCTA01Drug

    Diluted by 0.9% normal saline，IV

  • PlaceboOther

    IV

Study groups in NCT04709328
Study groupRoleWhat they receive
SCTA01 low dose +SOCExperimentalSCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Receives: Drug: SCTA01
SCTA01 middle dose+SOCExperimentalSCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Receives: Drug: SCTA01
SCTA01 High dose +SOCExperimentalSCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Receives: Drug: SCTA01
Placebo+SOCPlacebo comparatorSCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
Receives: Other: Placebo

What is being measured

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

  1. 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.

    Measured: Day 29

Secondary outcomes (22)

  1. Time to sustained resolution of all COVID-19-related symptoms

    Measured: Day 29

  2. - Change in symptom score (total of ratings)

    Measured: Day 3, 5, 7, 11, 15, 22, and 29

  3. Time to symptom improvement;

    Measured: Day 29

  4. Proportion of participants admitted to hospital due to COVID-19

    Measured: Day 29

  5. Proportion of participants with ≥1 COVID-19 related hospitalization

    Measured: Day 29

  6. Proportion of participants with ≥2 COVID-19 related hospitalizations

    Measured: Day 29

  7. Total number of COVID-19 related hospitalization

    Measured: Day 29

  8. Proportion of participants who experience COVID-19 related emergency room (ER) visit

    Measured: Day 29

  9. Proportion of participants with ≥1 ER visit due to COVID-19

    Measured: Day 29

  10. Proportion of participants with ≥2 ER visits due to COVID-19 through Day 29

    Measured: Day 29

  11. Proportion of participants admitted to an intensive care unit (ICU) due to COVID-19

    Measured: Day 29

  12. Proportion of patients with all-cause mortality

    Measured: Day 29

  13. Proportion of participants with O2 requirement

    Measured: Day 29

  14. Proportion of participants with ventilation requirements

    Measured: Day 29

  15. Proportion of participants that achieve SARS-CoV-2 clearance in nasopharyngeal (NP) or oropharyngeal (OP) samples

    Measured: Day 8, Day 15

  16. 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.

    Measured: Day 8, Day 15

  17. Cumulative incidence of serious adverse events (SAEs)

    Measured: Day 120

  18. Cumulative incidence of Grade 1, 2, 3 and 4 adverse events (AEs)

    Measured: Day 120

  19. Discontinuation or temporary suspension of infusions (for any reason)

    Measured: Day 120

  20. Number and proportion of patients with ADE

    Measured: Day 120

  21. Mean concentration-time profiles of SCTA01

    Measured: Day 29

  22. Incidence and titers (if applicable) of anti-drug antibodies (ADA) to SCTA01

    Measured: Day 1, Day 8, Day 29, and 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 posted14 Jan 2021
  2. Study start28 Mar 2021 (estimated)
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Mar 2022 (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
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
690 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04709328
Sponsor's protocol ID
SCTA01-A301
Acronym
MAOP3
Status last verified
Mar 2021
First submitted
13 Jan 2021
Last updated
29 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Diaz J, Fonseca A, Yan L, Liu D, Xie L. Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial. Contemp Clin Trials Commun. 2025 May 17;45:101496. doi: 10.1016/j.conctc.2025.101496. eCollection 2025 Jun.

    PubMed 40520909

  • 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 COVID-19 and SARS-CoV-2, 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 9 inclusion and 15 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: opening soon, as of the sponsor's last update on 29 Mar 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Qiang Guo, PhD (86-10-5862 8288, qiang_guo@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (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 NCT04709328, which also lists 2 linked publications.

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 29 Mar 2021.

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