Created at Source Raw Value Validated value
June 25, 2024, noon usa

1. sars-cov-2 pcr ≥30 ct at screening 2. hypersensitivity to study drugs (active substance(s) or excipients) 3. body weight \< 40 kg 4. ast or alt \> 5 times the upper limit 5. cirrhosis child-pugh score c 6. is taking or is anticipated to require any prohibited therapies\* 7. participation in another interventional clinical study through day 28 with an investigational compound or device, including covid-19 therapeutics, where the study intervention is performed in the 28 days preceding the inclusion and the 10 days after the inclusion. investigators of the different clinical studies should agree on participant's inclusion 8. presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments 9. having received antiviral treatments against sars-cov-2 in the 14 days before the inclusion with exception of those having received one or two doses of nirmatrevir/r in the 24h preceding the inclusion in the study. 10. pregnant or breastfeeding female * study sops based on recommendations from the liverpool covid-19 interactions, french society for pharmacology and therapeutics and french speaking transplantation society will be provided to guide investigators

1. sars-cov-2 pcr ≥30 ct at screening 2. hypersensitivity to study drugs (active substance(s) or excipients) 3. body weight \< 40 kg 4. ast or alt \> 5 times the upper limit 5. cirrhosis child-pugh score c 6. is taking or is anticipated to require any prohibited therapies\* 7. participation in another interventional clinical study through day 28 with an investigational compound or device, including covid-19 therapeutics, where the study intervention is performed in the 28 days preceding the inclusion and the 10 days after the inclusion. investigators of the different clinical studies should agree on participant's inclusion 8. presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments 9. having received antiviral treatments against sars-cov-2 in the 14 days before the inclusion with exception of those having received one or two doses of nirmatrevir/r in the 24h preceding the inclusion in the study. 10. pregnant or breastfeeding female * study sops based on recommendations from the liverpool covid-19 interactions, french society for pharmacology and therapeutics and french speaking transplantation society will be provided to guide investigators

March 30, 2024, midnight usa

sars-cov-2 pcr ≥30 ct at screening hypersensitivity to study drugs (active substance(s) or excipients) body weight < 40 kg ast or alt > 5 times the upper limit cirrhosis child-pugh score c is taking or is anticipated to require any prohibited therapies* participation in another interventional clinical study through day 28 with an investigational compound or device, including covid-19 therapeutics, where the study intervention is performed in the 28 days preceding the inclusion and the 10 days after the inclusion. investigators of the different clinical studies should agree on participant's inclusion presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments having received antiviral treatments against sars-cov-2 in the 14 days before the inclusion with exception of those having received one or two doses of nirmatrevir/r in the 24h preceding the inclusion in the study. pregnant or breastfeeding female study sops based on recommendations from the liverpool covid-19 interactions, french society for pharmacology and therapeutics and french speaking transplantation society will be provided to guide investigators

sars-cov-2 pcr ≥30 ct at screening hypersensitivity to study drugs (active substance(s) or excipients) body weight < 40 kg ast or alt > 5 times the upper limit cirrhosis child-pugh score c is taking or is anticipated to require any prohibited therapies* participation in another interventional clinical study through day 28 with an investigational compound or device, including covid-19 therapeutics, where the study intervention is performed in the 28 days preceding the inclusion and the 10 days after the inclusion. investigators of the different clinical studies should agree on participant's inclusion presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments having received antiviral treatments against sars-cov-2 in the 14 days before the inclusion with exception of those having received one or two doses of nirmatrevir/r in the 24h preceding the inclusion in the study. pregnant or breastfeeding female study sops based on recommendations from the liverpool covid-19 interactions, french society for pharmacology and therapeutics and french speaking transplantation society will be provided to guide investigators

March 22, 2023, 4 p.m. usa

sars-cov-2 pcr ≥30 ct at screening hypersensitivity to study drugs (active substance(s) or excipients) creatinine clearance <30ml/mn/.73m² (ckd-epi) ast or alt > 5 times the upper limit is taking or is anticipated to require any prohibited therapies* participation in another interventional clinical study through day 28 with an investigational compound or device, including covid-19 therapeutics presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments having received antiviral treatments against sars-cov-2 in the 14 days before the inclusion pregnant or breastfeeding female study sops based on recommendations from the liverpool covid-19 interactions, french society for pharmacology and therapeutics and french speaking transplantation society will be provided to guide investigators

sars-cov-2 pcr ≥30 ct at screening hypersensitivity to study drugs (active substance(s) or excipients) creatinine clearance <30ml/mn/.73m² (ckd-epi) ast or alt > 5 times the upper limit is taking or is anticipated to require any prohibited therapies* participation in another interventional clinical study through day 28 with an investigational compound or device, including covid-19 therapeutics presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments having received antiviral treatments against sars-cov-2 in the 14 days before the inclusion pregnant or breastfeeding female study sops based on recommendations from the liverpool covid-19 interactions, french society for pharmacology and therapeutics and french speaking transplantation society will be provided to guide investigators

Oct. 21, 2022, 4 p.m. usa

sars-cov-2 pcr ≥32 ct at screening contra-indication to t/c contra-indication to nirmatrelvir/r • study sops based on recommendations from liverpool university (https://www.covid19-druginteractions.org/) will be provided to guide investigators creatinin clearance <30ml/mn/.73m² (ckd-epi) is taking or is anticipated to require any prohibited therapies. participation in another interventional clinical study through day 28 with an investigational compound or device, including covid-19 therapeutics. presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments previous exposure to t/c in the 6 months prior to randomization, or nirmatrelvir/r or other mabs in the 28 days preceding randomization argument for the presence of a variant resistant against the reference mabs, or, if variant identification is not available, the prevalence of variants resistant against the reference mabs at inclusion is >10% in the study site's area pregnant or breastfeeding female, unless additional data are available for the use of the study drugs in this population

sars-cov-2 pcr ≥32 ct at screening contra-indication to t/c contra-indication to nirmatrelvir/r • study sops based on recommendations from liverpool university (https://www.covid19-druginteractions.org/) will be provided to guide investigators creatinin clearance <30ml/mn/.73m² (ckd-epi) is taking or is anticipated to require any prohibited therapies. participation in another interventional clinical study through day 28 with an investigational compound or device, including covid-19 therapeutics. presence of any condition for which, in the opinion of the investigator, participation would not be in participant's best interest or that could prevent, limit, or confound the protocol-specified assessments previous exposure to t/c in the 6 months prior to randomization, or nirmatrelvir/r or other mabs in the 28 days preceding randomization argument for the presence of a variant resistant against the reference mabs, or, if variant identification is not available, the prevalence of variants resistant against the reference mabs at inclusion is >10% in the study site's area pregnant or breastfeeding female, unless additional data are available for the use of the study drugs in this population