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
Brief 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.

Unknown status
COVID19

Combination Product: MW33 injection

a recombinant fully human antibody to coronavirus

Combination Product: MW33 injection placebo

Placebo

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 80 Years
Countries
China
Locations

Shanghai Public Health Clinical Center
Shanghai, China

Investigator: Xianmin MENG
Contact: 18916081980
scmxm@126.com

Contacts

Bei ZHAO, Master
+86-18817773189
bei.zhao@mabwell.com

Song LU, Master
15216868129
song.lu@mabwell.com

Mabwell (Shanghai) Bioscience Co., Ltd.
NCT Number
MeSH Terms
COVID-19