U07.1 COVID-19, virus COVID-19, virus
Conditions
Interventions
MK-4482 tablet 400 mg. 800 mg will be administered orally every 12 hours for 5 days (10 doses in total). - Placebo. It will be administered orally every 12 hours for 5 days (10 doses in total).
Sponsors
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Demographics 7. Is an individual of any sex/gender, =18 years of age inclusive, at the time of providing the informed consent. Type of Participant and Disease Characteristics 6. Has the ability to complete ePRO data collection without assistance based on the judgment of the investigator. Participants without suspected or confirmed COVID-19 (screening while asymptomatic): An individual may be entered in the study while asymptomatic for COVID-19 if the individual meets all of the inclusion criteria with the exception of #1 (documented SARSCoV-2 infection) and #2 (signs/symptoms of COVID-19). For inclusion criteria #8 (male participant agrees to contraception requirements) and #9 (female participant who is not pregnant or breastfeeding and is not a POCBP or is a POCBP and agrees to contraception requirements), while use of contraception is not required while asymptomatic, expectations for contraception requirements during administration of study intervention and for the protocol-specified duration following completion of study intervention should be reviewed and agreed upon prior to enrollment. Participants with suspected or confirmed COVID-19 (screening while symptomatic): An individual who is screened due to suspected or confirmed presence of COVID-19 (including an individual who already entered into the study while asymptomatic) is eligible for inclusion in the study if the individual meets all of the following criteria. Refer to Appendix 7 for country-specific requirements. Type of Participant and Disease Characteristics 1. Has documentation of SARS-CoV-2 infection with sample collection =4 days prior to the day of randomization. Note: A positive SARS-CoV-2 test may be confirmed via PCR or other molecular or antigen tests that detect viral RNA or protein (viral antigen test is preferred), if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed for documentation of infection. Confirmation of SARS-CoV-2 infection must be performed (viral antigen test is preferred) just prior to randomization (ie, on the same day) to confirm eligibility if >48 hours has elapsed since the first positive SARS-CoV-2 test. Type of Participant and Disease Characteristics 2. Had 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 (=1 of which must be of moderate or severe intensity as reported by the participant to the investigator): • Cough • Sore throat • Nasal congestion or runny nose • Shortness of breath or difficulty breathing with exertion • Muscle or body aches • Fatigue • Fever >38.0 °C or chills • Nausea or vomiting or diarrhea • Change in sense of smell or change in sense of taste • Headache Type of Participant and Disease Characteristics 3. Has =1 of the following characteristics or underlying medical conditions associated with an increased risk of severe illness from COVID-19: • Advanced age: =75 years of age • Immunocompromised due to =1 of the following: i. Solid tumor receiving chemotherapy or other immunomodulating therapies for cancer within the last 12 months (hormone therapy alone does not qualify the participant for inclusion) ii. Hematologic malignancy, multiple myeloma, or myelodysplastic syndrome (active in the last 2 years) iii. History of a hematopoietic stem cell transplant, CAR T-cell therapy, or a s
Exclusion criteria
Exclusion criteria: Medical Conditions 3. Has a history of SARS-CoV-2 infection (with or without symptoms) within 30 days prior to randomization. Medical Conditions 4. Has a known respiratory co-infection confirmed by viral testing at the time of randomization. Participants without suspected or confirmed COVID-19 (screening while asymptomatic): An individual may not be entered in the study while asymptomatic for COVID-19 if the individual meets exclusion criteria #6 (unwilling to abstain from participation in another clinical study from randomization to Day 29) or #7 (previously participated in P023). Participants with suspected or confirmed COVID-19 (screening while symptomatic): An individual who is being screened due to suspected or confirmed presence of COVID-19 (including individuals who already entered into the study while asymptomatic) should be excluded from the study if the individual meets any of the following criteria. Refer to Appendix 7 for country-specific requirements. Medical Conditions 1. Is currently hospitalized or is expected to need hospitalization for COVID-19 imminently (eg, within 48 hours of randomization). Medical Conditions 2. Has =1 of the following signs/symptoms that are attributable to severe or critical COVID-19: • Shortness of breath at rest as reported by the participant to the investigator • Respiratory rate =30 breaths per minute • Heart rate =125 beats per minute • 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. • Receiving >4 liters/min supplemental oxygen for COVID-19 (but was not receiving supplemental oxygen prior to COVID-19), regardless of SpO2 Note: Exclusion criterion #2 only applies to signs/symptoms attributable to COVID-19. If a participant requires supplemental oxygen or has a chronically low SpO2 or other vital sign abnormalities for another reason (eg, chronic lung disease or chronic high altitude exposure), this exclusion criterion would not apply. Prior/Concomitant Therapy 5. Has received or plans to receive SARS-CoV-2-directed antivirals or monoclonal antibodies for the current episode of COVID-19 (other than study intervention and, if applicable, remdesivir as concomitant standard of care). Prior/Concomitant Therapy 6. Has received a COVID-19 vaccine within 30 days prior to randomization. Prior/Concurrent Clinical Study Experience 7. Is unwilling to abstain from participating in another clinical study from randomization through Day 29 involving the administration of an investigational or experimental medication (not licensed by regulatory agencies), including those for COVID-19 therapeutics. Note: participation in long-term follow-up of another clinical study for which the participant has completed study intervention and at least 5 half-lives for the study intervention have elapsed since the last dose is allowed. Diagnostic Assessments Not Applicable Other Exclusions 8. Has previously enrolled in MK-4482-023. Other Exclusions 9. Has known or suspected hypersensitivity to active or inactive ingredients of MOV. Other Exclusions 10. 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 |
|---|---|
| Statistical method: Stratified M&N method with CMH weights NAME OF THE RESULT: Occurrence of one or more of the following events: hospitalization (all causes), death (all causes) and/or AVM related to COVID-19 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to day 29;Statistical method: Stratified M&N method with CMH weights NAME OF THE RESULT: Occurrence of one or more of the following events: COVID-19-related hospitalization, COVID-19-related death, and/or COVID-19-related AVM PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Statistical method: Stratified M&N method with CMH weights NAME OF THE RESULT: Occurrence of one or more of the following events: hospitalization (all causes), death (all causes) and/or AVM related to COVID-19 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to day 29;Statistical method: Stratified M&N method with CMH weights NAME OF THE RESULT: Occurrence of one or more of the following events: COVID-19-related hospitalization, COVID-19-related death, and/or COVID-19-related AVM PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to day 29;Statistical method: Stratified log-rank test NAME OF THE RESULT: Time to sustained relief (no relapse) of 8 selected patient-reported signs and symptoms PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: From randomization to day 29 | — |
Countries
Argentina, Brazil, Bulgaria, Colombia, Egypt, Finland, France, Georgia, Germany, Italy, Japan, Korea South, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Romania, Spain, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactNELVA GARCIA
MERCK SHARP & DOHME PERU S.R.L.
Outcome results
None listed