A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19
- Conditions
- 07.1 COVID-19, virusCOVID-19, virusU07.1
- Registration Number
- PER-055-21
- Lead Sponsor
- Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Without starting enrollment
- Sex
- All
- Target Recruitment
- 0
A participant will be eligible for inclusion in the study only if all of the following criteria apply:
1.The participant is a household contact of an index case. The index case is a person with documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and must have:
a)A first positive SARS-CoV-2 test result from a sample collected within 72 hours prior to randomization of the participant(s), AND
b)At least 1 of the following symptoms attributable to COVID-19: fever =38.0ºC, chills, cough, sore throat, shortness of breath or difficulty breathing with exertion, fatigue, nasal congestion, runny nose, headache, muscle or body aches, nausea, vomiting, diarrhea, loss of taste, or loss of smell, with symptom onset no earlier than 5 days prior to randomization of the participant(s).
Note:
•To be considered a household contact, the individual must be currently residing with the index case and expect to continue residing with the index case through the duration of the study. Thus, the index case should not be hospitalized at the time of randomization.
•For the SARS-CoV-2 test for the index case, molecular or antigen tests that detect viral RNA or protein are allowed if authorized for use in the country. Serological tests that detect host antibodies generated in response to recent or prior infection are not allowed.
2.The participant does not have confirmed or suspected COVID-19.
3.The participant is willing and able to take oral medication.
4.The participant is male or female =18 years of age, at the time of providing documented informed consent.
Male Participants
5.Male participants are eligible to participate if they agree to the following during the intervention period and for at least 4 days after the last dose of study intervention:
•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 [Appendix 5]) 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. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
-Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Female Participants
6.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 (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), as described in Appendix 5 during the intervention period and for at least 4 days after the last dose 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 pregnanc
A participant must be excluded from the study if any of the following criteria apply:
Medical Conditions
1.The participant has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms).
2.The participant is on dialysis or has reduced eGFR <30 mL/min/1.73 m2 (by the MDRD equation [Appendix 9])
3.The participant has either of the following conditions:
•HIV with a recent viral load >50 copies/mL (regardless of CD4 count) or an AIDS- defining illness in the past 6 months
Note: Participants with HIV may only be enrolled if on a stable antiretroviral therapy regimen.
•A neutrophilic granulocyte absolute count <500/mm3
4.The participant has a history of HBV or HCV infection with any of the following:
•Cirrhosis
•End-stage liver disease
•Hepatocellular carcinoma
•AST and/or ALT >3X upper limit of normal at screening
5.The participant has a platelet count <100,000/µL or received a platelet transfusion in the 5 days prior to randomization.
6.The participant has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator.
7.The participant 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 with conditions that could limit gastrointestinal absorption of capsule contents.
Prior/Concomitant Therapy
8.The participant is taking or is anticipated to require any prohibited therapies as outlined in Section 6.5.
MK-4482-013-00 FINAL PROTOCOL14-JUN-2021
9.The participant has received a COVID-19 vaccine with the first dose 7 days or more prior to randomization.
Prior/Concurrent Clinical Study Experience
10.The participant 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.
Diagnostic Assessments
Not applicable.
Other Exclusions:
11.The participant has more than 1 individual currently (assessed at the time of consent), or within the last month, living in the household with confirmed or suspected COVID-19.
12.The participant is living in a household of more than 10 people.
13.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method