NCT04627584

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 29, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

November 12, 2020

Last Update Submit

February 24, 2021

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

  • SARS-CoV-2 viral load

    Change in time-weighted SARS-CoV-2 viral load in nasopharyngeal swabs from baseline to day 7

    7 Days

Study Arms (3)

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

Interventions

MW33 injectionCOMBINATION_PRODUCT

a recombinant fully human antibody to coronavirus

MW33 injection-1200mgMW33 injection-2400mg
MW33 injection placeboCOMBINATION_PRODUCT

Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, 201052, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34473343DERIVED

  • Meng 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.

    PMID: 34346827DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Bei ZHAO, Master

CONTACT

+86-18817773189bei.zhao@mabwell.com

Song LU, Master

CONTACT

15216868129song.lu@mabwell.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

November 13, 2020

Study Start

December 29, 2020

Primary Completion

May 1, 2021

Study Completion

September 1, 2021

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

CN(1)