Molnupiravir for COVID-19

(MOVe-NOW Trial)

Recruiting at 173 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Antivirals, Monoclonal antibodies

Disqualifiers: Hospitalized, Severe COVID-19 symptoms, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

3082 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking drugs that interact with nirmatrelvir/ritonavir, you may not be eligible for this trial.

What makes the drug Molnupiravir unique for treating COVID-19?

Molnupiravir is unique because it is an oral antiviral drug that works by causing errors in the virus's genetic material, preventing it from replicating. Unlike some other treatments, it is taken by mouth and was originally developed for other RNA viruses, making it versatile against various viral infections. ^{1 2 3 4 5}

What is the purpose of this trial?

Researchers are looking for other ways to prevent severe illness from COVID-19. COVID-19 is a virus that most often causes mild flu or cold-like symptoms. However, people with certain health conditions or other factors have a high risk (chance) of getting severely ill from COVID-19, which can require a hospital stay or lead to death. Some people who are high risk for severe illness may be unable to take certain treatments for COVID-19 because they are not available to them, or they take other medicines that may react with a treatment and cause an unwanted effect. Molnupiravir (MK-4482) is a study medicine designed to stop the COVID-19 virus from copying itself in the body (multiplying). The goal of this study is to learn if molnupiravir prevents severe illness from COVID-19 more than placebo in people who are high risk.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults over 18 at high risk of severe COVID-19 due to factors like advanced age (≥75), certain chronic conditions, or being immunocompromised. Participants must have early-stage symptoms and confirmed SARS-CoV-2 infection. Those with severe kidney or liver issues, taking specific other medications, or unable to take existing treatments may qualify.

Inclusion Criteria

Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization

I started showing COVID-19 symptoms less than 4 days ago and have at least two of the listed symptoms today.

I am 75 or older, have a weakened immune system, or have a disability.

Exclusion Criteria

I am in the hospital or will be soon due to COVID-19.

I had COVID-19 within the last 30 days.

I am receiving or planning to receive COVID-19 antivirals or monoclonal antibodies.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 800 mg molnupiravir or placebo orally every 12 hours for 5 days

1 week

Daily visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Extended Follow-up

Participants are monitored for adverse events and other outcomes

Up to 5 months

Treatment Details

Interventions

• Molnupiravir

Trial Overview The study compares Molnupiravir, a medication intended to prevent the COVID-19 virus from multiplying in the body, against a placebo. The main goal is to see if Molnupiravir can better prevent serious illness from COVID-19 in high-risk individuals.

Participant Groups

Group I: Molnupiravir Experimental Treatment 1 Intervention

Participants will receive 800 mg molnupiravir orally every 12 hours for 5 days (a total of 10 consecutive doses)

Group II: Placebo Placebo Group 1 Intervention

Participants will receive molnupiravir-matching placebo orally every 12 hours for 5 days (a total of 10 consecutive doses)

Molnupiravir is already approved in United Kingdom, United States for the following indications:

Approved in United Kingdom as Lagevrio for:

• Treatment of established infections of COVID-19

Approved in United States as Lagevrio for:

• Treatment of mild to moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Molnupiravir is an oral antiviral medication that works by inducing errors in the replication of RNA viruses, making it effective against COVID-19.

It received its first approval in the UK on November 4, 2021, for treating mild to moderate COVID-19 in adults at risk of severe illness, and has since been authorized for emergency use in several other countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molnupiravir: First Approval. Syed, YY.[2022]

Molnupiravir is a safe and tolerable oral antiviral drug for COVID-19, with phase 1 studies showing no serious adverse events at a daily dose of 1600 mg over 5.5 days.

In phase 2 and 3 studies, molnupiravir significantly reduced the time to viral clearance and decreased the risk of hospitalization or death by 50% in non-hospitalized patients with mild to moderate COVID-19, although it showed no significant benefit in later stages of moderate to severe COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molnupiravir in COVID-19: A systematic review of literature. Singh, AK., Singh, A., Singh, R., et al.[2023]

Molnupiravir is an experimental antiviral that works by inhibiting viral polymerase, showing potent activity against various RNA viruses, including SARS-CoV-2, with a favorable safety profile and low cytotoxicity.

In clinical trials, molnupiravir reduced the risk of hospitalization or death by 30% in COVID-19 patients, leading to its emergency use authorization by regulatory agencies in the U.K. and the U.S.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molnupiravir for the treatment of COVID-19. Santani, BG., LeBlanc, BW., Thakare, RP.[2022]

Molnupiravir, originally developed for treating Alphavirus infections, has been repurposed as a potential antiviral drug for COVID-19, addressing the urgent need for effective treatments against SARS-CoV-2, especially for immune-suppressed individuals.

The accelerated development of molnupiravir was facilitated by real-time consultations with regulatory authorities, highlighting the importance of collaboration in responding to public health emergencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a direct acting, orally available antiviral agent in a pandemic: the evolution of molnupiravir as a potential treatment for COVID-19. Painter, GR., Natchus, MG., Cohen, O., et al.[2022]

In a phase 3 study involving 1433 non-hospitalized COVID-19 patients, molnupiravir significantly reduced the risk of hospital admission or death by 3.0%, indicating its potential efficacy in treating COVID-19.

Molnupiravir is a cost-effective treatment option for non-pregnant unvaccinated adults at increased risk of severe COVID-19, showing safety with no obvious short-term side effects when administered within 5 days of symptom onset.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An updated practical guideline on use of molnupiravir and comparison with agents having emergency use authorization for treatment of COVID-19. Singh, AK., Singh, A., Singh, R., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Molnupiravir: First Approval. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Molnupiravir in COVID-19: A systematic review of literature. [2023]

3. Spain pubmed.ncbi.nlm.nih.gov

Molnupiravir for the treatment of COVID-19. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Developing a direct acting, orally available antiviral agent in a pandemic: the evolution of molnupiravir as a potential treatment for COVID-19. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

An updated practical guideline on use of molnupiravir and comparison with agents having emergency use authorization for treatment of COVID-19. [2022]