A Phase 2 Clinical Trial of MW33 Injection in Patients With COVID-19

February 24, 2021 updated by: Mabwell (Shanghai) Bioscience Co., Ltd.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 201052
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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);
  2. 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;
  3. The SARS-CoV-2 nasopharyngeal nucleic acid is tested to be positive (RT-PCR), IgM (-)/IgG (-) or IgM (+)/IgG (-) within 3 days before randomization;
  4. Male or female subjects aged 18 to 80 years (including 18 and 80 years);
  5. 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;
  6. 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.

Exclusion Criteria:

  1. 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);

  2. 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;

  3. 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;
  4. Currently suffering from serious systemic diseases or mental disorders, and ineligible to participate in the study judged by the investigator;
  5. A history of severe trauma, fracture, or surgery within 4 weeks prior to screening, or possibility of requiring a major surgery during the study;
  6. Participated in clinical trials of SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody;
  7. Received or being receiving the convalescent plasma from patients recovered from COVID-19;
  8. Prior or current use of antiviral drugs for treatment of COVID-19, including Remdesivir, Tocilizumab, Interferon, Ribavirin, Abidol, Lopinavir, and Ritonavir, etc.
  9. 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);
  10. 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;
  11. Females who are pregnant or lactating;
  12. Any conditions that are not suitable for enrollment judged by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Combination product: MW33 injection placebo
Placebo
Active Comparator: MW33 injection-1200mg
Combination product: MW33 injection
a recombinant fully human antibody to coronavirus
Active Comparator: MW33 injection-2400mg
Combination product: MW33 injection
a recombinant fully human antibody to coronavirus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MW33-2020-CP201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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