Created at Source Raw Value Validated value
April 8, 2022, 3:30 p.m. oms

1.The participant is a household contact of an index case. An 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 =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. There are no contraceptive requirements for male participants per protocol.However,where applicable,male participants are only eligible to participate if they agree to follow local labelling (or local ethics or regulatory authority requirement) regardingcontraception.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.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. Documented informed consent.

1.The participant is a household contact of an index case. An 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 =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. There are no contraceptive requirements for male participants per protocol.However,where applicable,male participants are only eligible to participate if they agree to follow local labelling (or local ethics or regulatory authority requirement) regardingcontraception.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.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. Documented informed consent.