COVID-19 MedDRA version: 23.0 Level: LLT Classification code 10084382 Term: Coronavirus disease 2019 System Organ Class: 100000004862
Conditions
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has documentation of PCR-confirmed SARS-CoV-2 infection with sample collection =7 days prior to the day of randomization. 2. Had initial onset of signs/symptoms attributable to COVID-19 for =7 days prior to the day of randomization and at least 1 of the following signs/symptoms attributable to COVID-19 on the day of randomization: -Cough -Sore throat -Nasal congestion -Runny nose -Shortness of breath or difficulty breathing with exertion -Muscle or body aches -Fatigue -Fever >38.0?C -Chills -Headache -Nausea -Vomiting -Diarrhea -Loss of smell -Loss of taste 3. Has mild or moderate COVID-19; participants with mild COVID-19 must have at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from COVID-19. 4. Is willing and able to take oral medication. 5. Is male or female =18 years of age, at the time of providing informed consent. 6. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: • Refrain from donating sperm PLUS either: • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR • Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below: Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a WOCBP OR • Is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), for 28 days from start of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. • A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. • If contraceptives are interrupted as standard of care management of COVID-19 patients and resumed at a later time point, such as at hospital discharge, then abstinence must be practiced for the defined period of back-up contraception per the contraceptive product labeling. After this period, contraceptive use must adhere to the Protocol. 8. Participant (or legally acceptable representative) has provided documented informed consent for the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64
Exclusion criteria
Exclusion criteria: 1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization. 2. Is on dialysis or has reduced eGFR 50 copies/mL or CD4 3X upper limit of normal at screening 5. Has a platelet count <100,000/µL or received a platelet transfusion in the 5 days prior to randomization. 6. Has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. 7. Has a baseline heart rate of <50 beats per minute at rest. 8. Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 9. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: -Participants who are not expected to survive longer than 48 hours after randomization, or -Participants with a recent history of mechanical ventilation, or -Participants with conditions that could limit gastrointestinal absorption of capsule contents. 10. Is taking or is anticipated to require any prohibited therapies as outlined in Protocol. 11. Is unwilling to abstain from participating in another interventional clinical study through Day 29 with an investigational compound or device, including those for COVID-19 therapeutics. 12. Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the efficacy of MK-4482 compared to placebo as assessed by the percentage of participants who are hospitalized and/or die from randomization through Day 29. 2. To evaluate the safety and tolerability of MK-4482 compared to placebo. ;Secondary Objective: 1. To evaluate the efficacy of MK-4482 compared to placebo as assessed by time to sustained resolution or improvement, and time to progression of each targeted self-reported signs/symptoms of COVID-19 from randomization through Day 29. 2. To evaluate the efficacy of MK-4482 compared to placebo as assessed by the odds of a more favorable response on the World Health Organization (WHO) 11-point ordinal scale on Day 3, End of Therapy (EOT), Day 10, Day 15, and Day 29. ;Primary end point(s): 1. Percentage of participants who are hospitalized and/or die 2. Percentage of participants with an adverse event (AE) 3. Percentage of participants who discontinued study intervention due to an AE ;Timepoint(s) of evaluation of this end point: 1. Up to 29 Days 2. Up to 7 Months 3. Up to 6 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to sustained resolution or improvement of each targeted COVID-19 signs/symptoms 2. Time to progression of targeted COVID-19 signs/symptoms 3. WHO 11-point outcomes score on a scale;Timepoint(s) of evaluation of this end point: 1. Up to 29 Days 2. Up to 29 Days 3. Up to 29 Days | — |
Countries
Brazil, Canada, Chile, Colombia, France, Germany, Israel, Italy, Mexico, Philippines, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactTayeb Naveed
Merck Sharp & Dohme (UK) Limited
Outcome results
None listed