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

PHRR210310-003403

MW33-2020-CP201

2021-CT0590

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

The 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.

Ongoing

COVID-19

Primary efficacy endpoints:
Time-weighted average change in SARS-CoV-2 viral load in nasopharyngeal swabs from baseline to Day 7.

Safety evaluation:
1) Changes in vital signs (pulse, respiration, blood pressure and body temperature) at different timepoints before and after dosing
2) Changes in physical examination (skin and mucous membranes, lymph nodes, head and neck, chest and abdomen, spine and limbs) at different timepoints before and after dosing
3) Changes in laboratory tests (hematology, urinalysis, blood biochemistry, coagulation, IL-6, CD4+ T cells, erythrocyte sedimentation rate, C-reactive protein (CRP) detection) at different timepoints before and after dosing
4) Changes in 12 – lead electrocardiogram at different timepoints before and after dosing
5) Incidence of adverse events (AE) and serious adverse events (SAE)

PK evaluation endpoints:
The following parameters will be evaluated:
1) MW33 maximum concentration (Cmax).
2) MW33 Area-under-the-curve (AUC0-inf).
3) Half-life (t1/2).
4) Terminal half-life.

Immunogenicity evaluation:
ADA/Nab positive rate.

Secondary efficacy endpoints:
1) Time from drug administration to viral clearance.
2) Time when clinical symptoms (e.g., fever, respiratory symptoms, etc.) resolve.
3) The percentage of subjects requiring oxygen supplementation.
4) Change in laboratory parameters: lactate dehydrogenase, IL-6, CD4+ T cell, C-reactive protein, D dimer, erythrocyte sedimentation rate.

Recruiting

• China
• Philippines

Clinical Trial

20201229075106

2021-02-23

0000-00-00

150

Unspecified

Unspecified

2021-05-14

Inclusion Criteria
1) Patients diagnosed with mild or moderate COVID-19
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 ≤ 5 days prior to randomization.
3) The SARS-CoV-2 nasopharyngeal nucleic acid is tested to be positive firstly (RT-PCR) within 3 days before randomization, and IgM (-)/IgG (-) or IgM (+)/IgG (-);
4) Male or female subjects aged 18 to 80 years inclusive;
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) Diagnosis of severe or critical COVID-19
2) Have 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) Are suspected or diagnosed with serious bacterial, fungal, viral, or other infection (except SARS-CoV-2 infection). Subjects who in the opinion of the investigator, suffer from conditions that will prevent the subject from completing the study or impact interpretation of the study results.
4) Are currently suffering from serious systemic diseases or mental disorders, and ineligible to participate in the study judged by the investigator.
5) Have an history of severe trauma, fracture, or surgery within 4 weeks prior to screening, or possibility of requiring a major surgery during the study.
6) Have received a SARS-CoV-2 vaccine or anti-SARS-CoV-2 monoclonal antibody.
7) Have received or are 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 a clinical study with other drugs or devices or has been enrolled within previous 30 days, or within 5 half-lives, or within the biological effect period of the drug (whichever is longer).
10) 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 at potential risk from enrollment.
11) Females who are pregnant or lactating;
12) Any conditions that are not suitable for enrollment judged by the investigator.

Interventional

MW33 (full name: 9MW3311)

MW33 is a fully human monoclonal neutralizing antibody of natural structure and is an IgG1κ subtype, with stable antibody structure and lower immunogenicity.

Randomized

Double Blind

Unspecified

Not Applicable

Primary Efficacy Objective: Evaluate the virologic efficacy of MW33 Injection in patients with mild or moderate COVID-19 compared to placebo as assessed by quantitative PCR for SARS-CoV-2 viral load in nasopharyngeal swabs from baseline to Day 7.

Phase II