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New treatment option for Coronavirus Disease (COVID-19)
Official title A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
ClinicalTrials.gov ID: NCT06667700
What this study is testing
What is Molnupiravir?
Molnupiravir is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for coronavirus disease (covid-19).
Also referred to as MK-4482, LAGEVRIO®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main include but are not limited to the following:
- Is an individual of any sex/gender, ≥18 years of age
- Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization
- Has initial onset of signs/symptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs/symptoms...
- Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19:
You likely can't join if
- The main exclusion criteria include but are not limited to the following:
- Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently
- Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study...
- Has ≥1 of the following signs/symptoms that are attributable to severe or critical COVID-19:
- Shortness of breath at rest
- Respiratory rate ≥30 breaths per minute
See the full eligibility criteria
- The main include but are not limited to the following:
- Is an individual of any sex/gender, ≥18 years of age
- Has documentation of SARS-CoV-2 infection with sample collection ≤4 days prior to randomization
- Has initial onset of signs/symptoms attributable to COVID-19 for ≤4 days prior to the day of randomization and ≥2 of the following signs/symptoms attributable to COVID-19 on the day of randomization: cough, sore throat...
- Has ≥1 of the following characteristics or medical conditions associated with the highest risk of severe illness from COVID-19:
- Advanced age of ≥75 years of age
- Immunocompromised
- Neurocognitive or physical disability
- Has ≥3 characteristics or medical conditions which increase the risk of severe illness due to COVID-19 (e.g., chronic lung disease, obesity with body mass index (BMI) ≥35, diabetes)
- Is unable or unwilling to receive treatment with nirmatrelvir/ritonavir (NMV/r) due to 1 or more of the following:
- Is receiving drug(s) highly dependent on cytochrome P450 3A (CYP3A) for clearance and for which elevated concentrations are associated with serious and/or life-threatening consequences or drug(s) with a clinically...
- Is receiving potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance
- Has severe hepatic impairment
- Has experienced prior adverse reactions or hepatotoxicity to NMV/r that would preclude future use
- Has known or suspected NMV/r resistance
- Has uncontrolled HIV infection
- NMV/r is not approved/authorized in the participant's country or it is not accessible to participant (e.g., drug shortage)
- Is unwilling to receive treatment with NMV/r Inclusion note: Participants may receive remdesivir as standard of care in addition to molnupiravir or placebo. If remdesivir is available and clinically appropriate per...
- The main exclusion criteria include but are not limited to the following:
- Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently
- Has received or plans to receive SARS-CoV-2 directed oral antivirals or monoclonal antibodies for current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as standard of care)
- Has ≥1 of the following signs/symptoms that are attributable to severe or critical COVID-19:
- Shortness of breath at rest
- Respiratory rate ≥30 breaths per minute
- Heart rate ≥125 beats per minute
- Peripheral oxygen saturation (SpO2) ≤93% on room air or on supplemental oxygen for a reason other than COVID-19 which has not increased since onset of COVID-19 signs/symptoms
- New or increasing need for supplemental oxygen: receiving \>4 liters/minute supplemental oxygen due to COVID-19 OR on supplemental oxygen for a reason other than COVID-19 which has increased due to COVID-19
- Has received a COVID-19 vaccine within 30 days prior to randomization
- Has a history of confirmed influenza, respiratory syncytial virus (RSV), or SARS-CoV-2 infection (with or without symptoms; excluding current infection) within 30 days prior to randomization
- Has known or suspected hypersensitivity to active or inactive ingredients of molnupiravir
The study team makes the final eligibility decision.
Where it's taking place
- Cullman, Alabama, United States
- Paradise Valley, Arizona, United States
- Phoenix, Arizona, United States
- Castroville, California, United States
- Fullerton, California, United States
- Los Alamitos, California, United States
- Northridge, California, United States
- Oxnard, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Westlake Village, California, United States
- Wheat Ridge, Colorado, United States
- Boynton Beach, Florida, United States
- Coral Gables, Florida, United States
- Homestead, Florida, United States
- Largo, Florida, United States
- Leesburg, Florida, United States
- Loxahatchee Groves, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
+ 164 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cullman, Alabama, United States; Paradise Valley, Arizona, United States; Phoenix, Arizona, United States; Castroville, California, United States; Fullerton, California, United States; Los Alamitos, California, United States and 178 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.