Created at Source Raw Value Validated value
June 27, 2024, 4 p.m. usa

* history of hospitalization for the current sars-cov-2 infection (that is, prior hospitalization for a prior episode of sars-cov-2 infection is allowable) * for the current sars-cov-2 infection, any positive sars-cov-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, np, or nasal swab, or saliva) collected ˃72 hours (3 days) prior to randomization. participants with reinfection, defined as prior sars-cov-2 infection that began \>90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 3 days prior to randomization. * current need for hospitalization or immediate medical attention in the opinion of the investigator * current use of any medications prohibited with the study intervention. individuals who have used paxlovid or any other oral, inhaled, or injectable medication intended to treat the current sars-cov-2 infection before randomization are excluded. after randomization, locally available sars-cov-2 treatment (including but not limited to molnupiravir, mabs, outpatient iv remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for ddis. note: paxlovid use for a prior episode of covid-19 is permitted. * receipt of any investigational treatments for the current episode of sars-cov-2 at any time prior to randomization is exclusionary. note: this does not include drugs approved for other uses and taken for those indications or covid-19 vaccines. note: use of locally authorized or approved therapies to prevent covid-19, such as mabs given solely to prevent covid-19, are not exclusionary. * any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization * known allergy/sensitivity or any hypersensitivity to components of s-217622 or placebo for s-217622 * known (within 12 months prior to randomization) renal impairment defined as crcl \<30 ml/min by cockcroft-gault or requiring dialysis * known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy) * participants who have used any of the following drugs within 14 days prior to randomization: * strong cytochrome p453a (cyp 3a) inhibitor * strong cyp3a inducer * products containing st. john's wort

* history of hospitalization for the current sars-cov-2 infection (that is, prior hospitalization for a prior episode of sars-cov-2 infection is allowable) * for the current sars-cov-2 infection, any positive sars-cov-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, np, or nasal swab, or saliva) collected ˃72 hours (3 days) prior to randomization. participants with reinfection, defined as prior sars-cov-2 infection that began \>90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 3 days prior to randomization. * current need for hospitalization or immediate medical attention in the opinion of the investigator * current use of any medications prohibited with the study intervention. individuals who have used paxlovid or any other oral, inhaled, or injectable medication intended to treat the current sars-cov-2 infection before randomization are excluded. after randomization, locally available sars-cov-2 treatment (including but not limited to molnupiravir, mabs, outpatient iv remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for ddis. note: paxlovid use for a prior episode of covid-19 is permitted. * receipt of any investigational treatments for the current episode of sars-cov-2 at any time prior to randomization is exclusionary. note: this does not include drugs approved for other uses and taken for those indications or covid-19 vaccines. note: use of locally authorized or approved therapies to prevent covid-19, such as mabs given solely to prevent covid-19, are not exclusionary. * any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization * known allergy/sensitivity or any hypersensitivity to components of s-217622 or placebo for s-217622 * known (within 12 months prior to randomization) renal impairment defined as crcl \<30 ml/min by cockcroft-gault or requiring dialysis * known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy) * participants who have used any of the following drugs within 14 days prior to randomization: * strong cytochrome p453a (cyp 3a) inhibitor * strong cyp3a inducer * products containing st. john's wort

April 17, 2023, 8:14 a.m. usa

history of hospitalization for the current sars-cov-2 infection (that is, prior hospitalization for a prior episode of sars-cov-2 infection is allowable) for the current sars-cov-2 infection, any positive sars-cov-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, np, or nasal swab, or saliva) collected ˃72 hours (3 days) prior to randomization. participants with reinfection, defined as prior sars-cov-2 infection that began >90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 3 days prior to randomization. current need for hospitalization or immediate medical attention in the opinion of the investigator current use of any medications prohibited with the study intervention. individuals who have used paxlovid or any other oral, inhaled, or injectable medication intended to treat the current sars-cov-2 infection before randomization are excluded. after randomization, locally available sars-cov-2 treatment (including but not limited to molnupiravir, mabs, outpatient iv remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for ddis. note: paxlovid use for a prior episode of covid-19 is permitted. receipt of any investigational treatments for the current episode of sars-cov-2 at any time prior to randomization is exclusionary. note: this does not include drugs approved for other uses and taken for those indications or covid-19 vaccines. note: use of locally authorized or approved therapies to prevent covid-19, such as mabs given solely to prevent covid-19, are not exclusionary. any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization known allergy/sensitivity or any hypersensitivity to components of s-217622 or placebo for s-217622 known (within 12 months prior to randomization) renal impairment defined as crcl <30 ml/min by cockcroft-gault or requiring dialysis known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy) participants who have used any of the following drugs within 14 days prior to randomization: strong cytochrome p453a (cyp 3a) inhibitor strong cyp3a inducer products containing st. john's wort

history of hospitalization for the current sars-cov-2 infection (that is, prior hospitalization for a prior episode of sars-cov-2 infection is allowable) for the current sars-cov-2 infection, any positive sars-cov-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, np, or nasal swab, or saliva) collected ˃72 hours (3 days) prior to randomization. participants with reinfection, defined as prior sars-cov-2 infection that began >90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 3 days prior to randomization. current need for hospitalization or immediate medical attention in the opinion of the investigator current use of any medications prohibited with the study intervention. individuals who have used paxlovid or any other oral, inhaled, or injectable medication intended to treat the current sars-cov-2 infection before randomization are excluded. after randomization, locally available sars-cov-2 treatment (including but not limited to molnupiravir, mabs, outpatient iv remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for ddis. note: paxlovid use for a prior episode of covid-19 is permitted. receipt of any investigational treatments for the current episode of sars-cov-2 at any time prior to randomization is exclusionary. note: this does not include drugs approved for other uses and taken for those indications or covid-19 vaccines. note: use of locally authorized or approved therapies to prevent covid-19, such as mabs given solely to prevent covid-19, are not exclusionary. any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization known allergy/sensitivity or any hypersensitivity to components of s-217622 or placebo for s-217622 known (within 12 months prior to randomization) renal impairment defined as crcl <30 ml/min by cockcroft-gault or requiring dialysis known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy) participants who have used any of the following drugs within 14 days prior to randomization: strong cytochrome p453a (cyp 3a) inhibitor strong cyp3a inducer products containing st. john's wort

Aug. 30, 2022, 9:30 p.m. usa

history of hospitalization for the current sars-cov-2 infection (that is, prior hospitalization for a prior episode of sars-cov-2 infection is allowable) for the current sars-cov-2 infection, any positive sars-cov-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, np, or nasal swab, or saliva) collected ˃120 hours (5 days) prior to randomization. participants with reinfection, defined as prior sars-cov-2 infection that began >90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 5 days prior to randomization. current need for hospitalization or immediate medical attention in the opinion of the investigator current use of any medications prohibited with the study intervention. use of paxlovid at any time and the use of any oral, inhaled, or injectable medication intended to treat symptomatic sars-cov-2 infection before enrollment are excluded. after enrollment, locally available sars-cov-2 treatment (including but not limited to molnupiravir, mabs, outpatient iv remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for ddis. receipt of any investigational treatments for the current episode of sars-cov-2 at any time prior to randomization is exclusionary. note: this does not include drugs approved for other uses and taken for those indications or covid-19 vaccines. note: use of locally authorized or approved therapies to prevent covid-19, such as mabs given solely to prevent covid-19, are not exclusionary. any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization known allergy/sensitivity or any hypersensitivity to components of s-217622 or placebo for s-217622 known current renal impairment defined as crcl <30 ml/min by cockcroft-gault or requiring dialysis known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy) participants who have used any of the following drugs within 14 days prior to enrollment: strong cytochrome p453a (cyp 3a) inhibitor strong cyp3a inducer products containing st. john's wort

history of hospitalization for the current sars-cov-2 infection (that is, prior hospitalization for a prior episode of sars-cov-2 infection is allowable) for the current sars-cov-2 infection, any positive sars-cov-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, np, or nasal swab, or saliva) collected ˃120 hours (5 days) prior to randomization. participants with reinfection, defined as prior sars-cov-2 infection that began >90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 5 days prior to randomization. current need for hospitalization or immediate medical attention in the opinion of the investigator current use of any medications prohibited with the study intervention. use of paxlovid at any time and the use of any oral, inhaled, or injectable medication intended to treat symptomatic sars-cov-2 infection before enrollment are excluded. after enrollment, locally available sars-cov-2 treatment (including but not limited to molnupiravir, mabs, outpatient iv remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for ddis. receipt of any investigational treatments for the current episode of sars-cov-2 at any time prior to randomization is exclusionary. note: this does not include drugs approved for other uses and taken for those indications or covid-19 vaccines. note: use of locally authorized or approved therapies to prevent covid-19, such as mabs given solely to prevent covid-19, are not exclusionary. any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization known allergy/sensitivity or any hypersensitivity to components of s-217622 or placebo for s-217622 known current renal impairment defined as crcl <30 ml/min by cockcroft-gault or requiring dialysis known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy) participants who have used any of the following drugs within 14 days prior to enrollment: strong cytochrome p453a (cyp 3a) inhibitor strong cyp3a inducer products containing st. john's wort

April 1, 2022, 3:30 p.m. usa

history of hospitalization for the current sars-cov-2 infection (for example, prior hospitalization for a prior episode of sars-cov-2 infection is allowable). for the current sars-cov-2 infection, any positive sars-cov-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, np, or nasal swab, or saliva) collected ˃120 hours (5 days) prior to randomization. participants with reinfection, defined as prior sars-cov-2 infection that began >90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 5 days prior to randomization. current need for hospitalization or immediate medical attention in the opinion of the investigator. current use of or anticipated need for any medications prohibited with the study drug. use of paxlovid or any oral, inhaled, or injectable medication intended to treat symptomatic sars-cov-2 infection before or at enrollment is excluded. after enrollment, locally available sars-cov-2 treatment (including but not limited to molnupiravir, mabs, outpatient administration of iv remdesivir, convalescent plasma, inhaled budesonide, and fluvoxamine) will be permitted, as long as there are no concerns for ddis. receipt of any investigational treatments for the current episode of sars-cov-2 at any time prior to randomization is exclusionary. note: this does not include drugs approved for other uses and taken for those indications or covid-19 vaccines. any co-morbidity requiring surgery within 7 days prior to randomization, or that is considered life-threatening in the opinion of the investigator within 28 days prior to randomization known allergy/sensitivity or any hypersensitivity to components of s-217622, or placebo for s-217622. known current renal impairment defined as creatinine clearance (crcl) <30 milliliters per minute (ml/min) by cockcroft-gault or requiring dialysis. known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). participants who have used any of the following drugs within 14 days prior to enrollment: strong cyp 3a inhibitor strong cyp3a inducer products containing st. john's wort

history of hospitalization for the current sars-cov-2 infection (for example, prior hospitalization for a prior episode of sars-cov-2 infection is allowable). for the current sars-cov-2 infection, any positive sars-cov-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, np, or nasal swab, or saliva) collected ˃120 hours (5 days) prior to randomization. participants with reinfection, defined as prior sars-cov-2 infection that began >90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 5 days prior to randomization. current need for hospitalization or immediate medical attention in the opinion of the investigator. current use of or anticipated need for any medications prohibited with the study drug. use of paxlovid or any oral, inhaled, or injectable medication intended to treat symptomatic sars-cov-2 infection before or at enrollment is excluded. after enrollment, locally available sars-cov-2 treatment (including but not limited to molnupiravir, mabs, outpatient administration of iv remdesivir, convalescent plasma, inhaled budesonide, and fluvoxamine) will be permitted, as long as there are no concerns for ddis. receipt of any investigational treatments for the current episode of sars-cov-2 at any time prior to randomization is exclusionary. note: this does not include drugs approved for other uses and taken for those indications or covid-19 vaccines. any co-morbidity requiring surgery within 7 days prior to randomization, or that is considered life-threatening in the opinion of the investigator within 28 days prior to randomization known allergy/sensitivity or any hypersensitivity to components of s-217622, or placebo for s-217622. known current renal impairment defined as creatinine clearance (crcl) <30 milliliters per minute (ml/min) by cockcroft-gault or requiring dialysis. known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). participants who have used any of the following drugs within 14 days prior to enrollment: strong cyp 3a inhibitor strong cyp3a inducer products containing st. john's wort