COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000904-39/BG

Not reported

Not reported

2022-03-14

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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 detectable SARS-CoV-2 test result from a sample collected within <5 days 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). 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. 5. Male participants must agree to be abstinent from penile-vaginal intercourse OR agree to use a highly effective contraceptive method while receiving study drug and for at least 3 months after the last dose of study drug. 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 uses a contraceptive method that is highly effective (a low user dependency method OR a user dependent hormonal 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), 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. - Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. - Has a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention. - Has had her medical history, menstrual history, and recent sexual activity reviewed by the investigator to decrease the risk for inclusion of a woman with an early undetected pregnancy. - If contraceptives are interrupted in case of standard of care management of COVID-19 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 protocol. 7. The participant’s index case (or legally acceptable representative of the index case) has provided documented informed consent/assent for the collection of COVID-19 documentation requirements. 8. The participant (or legally acceptable representative) has provided documented informed consent to participate in the study. The participant may also provide consent for participation in FBR but may participate in the study without participating in FBR.

1. The participant has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without symptoms) within 6 months prior to randomization. 2. 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 3. 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 4. The participant has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator. 5. 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. 6. The participant has received, is taking, or is anticipated to require any prohibited therapies as outlined in the protocol. 7. The participant has received a COVID-19 vaccine with the first dose 7 days or more prior to randomization. 8. 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. 9. The participant is living in a household of more than 10 people. 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.

2

Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.

18

100

Argentina;Brazil;Colombia;Dominican Republic;Egypt;Guatemala;Japan;Malaysia;Mexico;Peru;Philippines;South Africa;Thailand;United States;France;Bulgaria;Romania;Spain;Hungary;Russia;Turkey;Ukraine

Close contacts to covid patients

N/A

225

1. Percentage of participants who have undetectable SARS-CoV-2 in baseline NP swabs and develop COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms) through Day 14 2. Percentage of participants with ≥1 adverse event 3. Percentage of participants discontinuing from study therapy due to AE

Declared number of arm (3.0) differs from found arms (2.0)

Phase 3

[{"arm_notes": "New Type treatment : Molnupiravir", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "New Type treatment : Molnupiravir", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]