Covid19Phase 2NCT04627584
A Phase 2 Clinical Trial of MW33 Injection in Patients With COVID-19
A Phase 2 study testing MW33 injection in people with Covid19, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the clinical efficacy and safety of MW33 injection in patients with mild or moderate COVID-19, and to evaluate its pharmacokinetic profile and immunogenicity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- MW33 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2020to Sep 2021
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with mild or moderate COVID-19 (as per the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial, 8th edition), China, or Clinical Management of COVID-19, WHO);
- Has at least one COVID-19 symptom, e.g., fever, cough, shortness of breath, sore throat, headache, muscle ache, and other respiratory or gastrointestinal symptoms, and has the symptom for ≤ 7 days prior to randomization;
- The SARS-CoV-2 nasopharyngeal nucleic acid is tested to be positive (RT-PCR), IgM (-)/IgG (-) or IgM (+)/IgG (-) within 3 days before randomization;
- Male or female subjects aged 18 to 80 years (including 18 and 80 years);
- Subjects do not have a pregnancy plan, voluntarily take effective contraceptive measures during the screening period and the next 6 months, and have no sperm and egg donation plans, and voluntarily take non-pharmaceutical contraception measures during the trial period;
- Subjects voluntarily sign the informed consent form (ICF) based on sufficient knowledge of the nature, purpose, and procedures of the study, and shall be willing to comply with the study regulations.
Who cannot join
- A subject who was diagnosed with severe or critical COVID-19 (as per the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial, 8th edition), China, or Clinical Management of COVID-19, WHO);
- Abnormal important organ function indicators, which meet the following conditions:
- ① Liver function: serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) > 5.0 × upper limit of normal (ULN);
- ② Renal function: patients treated with dialysis or eGFR< 60 mL/min.
- ③ Cardiac function: patients with results of 12-lead ECG suggesting conduction block or acute myocardial infarction requiring urgent management;
- Suspected or diagnosed with serious bacterial, fungal, viral, or other infection (except SARS-CoV-2 infection). In the opinion of the investigator, the conditions will prevent a subject from completing the study or impact interpretation of the study results;
Show all 15Show fewer
- Currently suffering from serious systemic diseases or mental disorders, and ineligible to participate in the study judged by the investigator;
- A history of severe trauma, fracture, or surgery within 4 weeks prior to screening, or possibility of requiring a major surgery during the study;
- Participated in clinical trials of SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody;
- Received or being receiving the convalescent plasma from patients recovered from COVID-19;
- Prior or current use of antiviral drugs for treatment of COVID-19, including Remdesivir, Tocilizumab, Interferon, Ribavirin, Abidol, Lopinavir, and Ritonavir, etc.
- Currently enrolled into clinical studies with other drugs or devices; the time to start of this study from the end of previous participation in other drug clinical studies is less than 30 days, or within 5 half-lives, or within the biological effect period of the drug (whichever is longer);
- Those who are known to be allergic to any component of the investigational product; or those who have a history of allergies and judged by the investigator to be ineligible for enrollment;
- Females who are pregnant or lactating;
- Any conditions that are not suitable for enrollment judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Public Health Clinical Center
Shanghai, 201052
Xianmin MENG, 18916081980, scmxm@126.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial of MW33 Injection to Evaluate the Efficacy and Safety in Patients With Mild or Moderate COVID-19
This study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the clinical efficacy and safety of MW33 injection in patients with mild or moderate COVID-19, and to evaluate its pharmacokinetic profile and immunogenicity.
- Conditions
- Covid19
- Being tested
- MW33 injection, MW33 injection 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.
MW33 injectionCombination product
a recombinant fully human antibody to coronavirus
MW33 injection placeboCombination product
Placebo
| Study group | Role | What they receive |
|---|---|---|
| MW33 injection-1200mg | Active comparator | Not described Receives: Combination Product: MW33 injection |
| MW33 injection-2400mg | Active comparator | Not described Receives: Combination Product: MW33 injection |
| Placebo | Placebo comparator | Not described Receives: Combination Product: MW33 injection placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 viral load
Change in time-weighted SARS-CoV-2 viral load in nasopharyngeal swabs from baseline to day 7
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start29 Dec 2020
- Primary completionMay 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627584
- Sponsor's protocol ID
- MW33-2020-CP201
- Status last verified
- Feb 2021
- First submitted
- 12 Nov 2020
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 34473343Meng X, Wang P, Xiong Y, Wu Y, Lin X, Lu S, Li R, Zhao B, Liu J, Zeng S, Zeng L, Wu Y, Lu Y, Zhang J, Liu D, Wang S, Lu H. Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: a Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody. Emerg Microbes Infect. 2021 Dec;10(1):1638-1648. doi: 10.1080/22221751.2021.1960900.
PubMed 34346827
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Trial of MW33 Injection to Evaluate the Efficacy and Safety in Patients With Mild or Moderate COVID-19
- ClinicalTrials.gov ID
- NCT04627584
- Acronym / sponsor ID
- MW33-2020-CP201
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the clinical efficacy and safety of MW33 injection in patients with mild or moderate COVID-19, and to evaluate its pharmacokinetic profile and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MW33 injection-1200mg | Active comparator | Combination Product: MW33 injection |
| MW33 injection-2400mg | Active comparator | Combination Product: MW33 injection |
| Placebo | Placebo comparator | Combination Product: MW33 injection placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with mild or moderate COVID-19 (as per the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial, 8th edition), China, or Clinical Management of COVID-19, WHO);
- Has at least one COVID-19 symptom, e.g., fever, cough, shortness of breath, sore throat, headache, muscle ache, and other respiratory or gastrointestinal symptoms, and has the symptom for ≤ 7 days prior to randomization;
- The SARS-CoV-2 nasopharyngeal nucleic acid is tested to be positive (RT-PCR), IgM (-)/IgG (-) or IgM (+)/IgG (-) within 3 days before randomization;
- Male or female subjects aged 18 to 80 years (including 18 and 80 years);
- Subjects do not have a pregnancy plan, voluntarily take effective contraceptive measures during the screening period and the next 6 months, and have no sperm and egg donation plans, and voluntarily take non-pharmaceutical contraception measures during the trial period;
Key exclusion criteria (15 listed)
- A subject who was diagnosed with severe or critical COVID-19 (as per the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial, 8th edition), China, or Clinical Management of COVID-19, WHO);
- Abnormal important organ function indicators, which meet the following conditions:
- ① Liver function: serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) > 5.0 × upper limit of normal (ULN);
- ② Renal function: patients treated with dialysis or eGFR< 60 mL/min.
- ③ Cardiac function: patients with results of 12-lead ECG suggesting conduction block or acute myocardial infarction requiring urgent management;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MW33 injectiona recombinant fully human antibody to coronavirus | Combination product | MW33 injection-1200mg, MW33 injection-2400mg |
| MW33 injection placeboPlacebo | Combination product | Placebo |
Primary outcome
SARS-CoV-2 viral load
Time frame: 7 Days
Change in time-weighted SARS-CoV-2 viral load in nasopharyngeal swabs from baseline to day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Derived from this study: PubMed 34346827Meng X, Wang P, Xiong Y, Wu Y, Lin X, Lu S, Li R, Zhao B, Liu J, Zeng S, Zeng L, Wu Y, Lu Y, Zhang J, Liu D, Wang S, Lu H. Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: a Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody. Emerg Microbes Infect. 2021 Dec;10(1):1638-1648. doi: 10.1080/22221751.2021.1960900.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MW33 injection in people with Covid19, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 Bei ZHAO, Master (+86-18817773189, bei.zhao@mabwell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SARS-CoV-2 viral load (time frame: 7 Days). 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 NCT04627584, 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 26 Feb 2021.