Molnupiravir for COVID-19

(MOVe-NOW Trial)

Recruiting at 246 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests molnupiravir to determine if it can prevent severe illness from COVID-19 in people at high risk. Molnupiravir, a study medicine, aims to stop the virus from multiplying in the body. The trial compares molnupiravir to a placebo (a pill with no active medicine) to assess effectiveness. Ideal candidates have experienced COVID-19 symptoms like cough or fever for four days or less and have conditions such as a weak immune system or chronic lung disease. Participants should not take certain other COVID-19 treatments that might interact negatively with their current medications. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that molnupiravir is likely to be safe for humans?

Research has shown that molnupiravir, a medicine under study for COVID-19, has undergone safety testing in several studies. In a large study involving over 1,400 COVID-19 patients, researchers compared molnupiravir to a placebo (a pill with no active ingredients) to assess any harmful effects. The study found that molnupiravir was generally well-tolerated, with most participants not experiencing serious side effects.

Another study examined reports of side effects from individuals taking molnupiravir, using data from the FDA's Adverse Event Reporting System. This study found that while some side effects were reported, they were usually not serious.

Overall, these studies suggest that molnupiravir is generally safe for use. However, like all medicines, it may cause side effects in some individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COVID-19?

Molnupiravir is unique because it works by introducing errors into the virus's genetic code, a mechanism known as viral mutagenesis. This is different from most current COVID-19 treatments, which typically target the virus's ability to replicate or its spike protein. Researchers are excited about molnupiravir because it can be taken orally, potentially allowing for easier access and administration compared to intravenous treatments like remdesivir. Moreover, molnupiravir has the potential to reduce viral load rapidly, which could lead to faster recovery times and decreased transmission.

What evidence suggests that molnupiravir might be an effective treatment for COVID-19?

Research has shown that molnupiravir, which participants in this trial may receive, can help reduce severe outcomes from COVID-19. Studies indicate it lowers the risk of hospitalization or death, especially in older adults. It remains effective against the Omicron variant of the virus. Other findings suggest that taking molnupiravir early can decrease the chance of severe illness in unvaccinated individuals. Overall, using molnupiravir is associated with a lower risk of dying from any cause within 30 days. ^{1 6 7 8 9}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1684118225000775

Effectiveness of molnupiravir as early treatment for COVID ... Molnupiravir significantly reduces the risk of mortality. It also lowers the risk of hospitalisation in the oldest group (mean age ≥75 years) but not in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04575597

Efficacy and Safety of Molnupiravir (MK-4482) in Non- ... This study aims to evaluate the safety, tolerability and efficacy of molnupiravir (MK-4482) compared to placebo.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38743192/

Molnupiravir Use Among Patients with COVID-19 in Real ... We found that treatment with molnupiravir was effective in reducing the risk of severe outcomes from COVID-19 caused by Omicron variants, especially for older ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2116044

Molnupiravir for Oral Treatment of Covid-19 in ... Early treatment with molnupiravir reduced the risk of hospitalization or death in at-risk, unvaccinated adults with Covid-19.

5. academic.oup.com academic.oup.com/ofid/article/11/12/ofae685/7904736

Real Clinical Effectiveness of Molnupiravir Against 30-day ... The use of molnupiravir in adult SARS-CoV-2 positive patients was associated with a lower risk of both 30-day all-cause mortality.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9821679/

Safety Profile of Molnupiravir in the Treatment of COVID-19 Molnupiravir safety data were captured from the FDA Adverse Event Reporting System (FAERS). We performed a descriptive analysis of the baseline ...

7. journals.asm.org journals.asm.org/doi/10.1128/aac.02428-20

Human Safety, Tolerability, and Pharmacokinetics of ... Molnupiravir has demonstrated in vitro activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human airway epithelial cell cultures.

8. lagevriohcp.com lagevriohcp.com/clinical-data/

Clinical Data for LAGEVRIO™ (molnupiravir) The safety of LAGEVRIO was evaluated based on an analysis of a Phase 3 double-blind trial (MOVe-OUT) in which 1,411 non-hospitalized subjects with COVID-19 were ...

9. merck.com merck.com/news/merck-provides-update-on-phase-3-move-ahead-trial-evaluating-lagevrio-molnupiravir-for-post-exposure-prophylaxis-for-prevention-of-covid-19/

Merck Provides Update on Phase 3 MOVe-AHEAD Trial ... Merck Provides Update on Phase 3 MOVe-AHEAD Trial Evaluating LAGEVRIO™ (molnupiravir) for Post-exposure Prophylaxis for Prevention of COVID-19.