Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: willing and able to provide informed consent for the trial, written, electronic, verbal or other method deemed acceptable by the institution and irb. 18 years of age or older. if discharged from the hospital prior to study day 15 or if follow up is needed for study drug-related adverse event, willing to go to an outpatient facility if feasible or be in contact with the study team (phone call or other digital media) for remaining study assessments. laboratory-confirmed sars-cov-2 infection as determined by real time polymerase chain reaction (rt-pcr) or other food and drug administration (fda)-cleared commercial or public health assay. hospitalized (in patient with expected duration ≥ 24 hours) the effects of brequinar on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. men and women treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for 90 days after completion of brequinar administration. male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of brequinar. ≤ 10 days since first covid-19 symptom as determined by treating clinician. able to swallow capsules. at least one covid-19 symptom including but not limited to fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath, dyspnea, dysgeusia, or other symptom commonly associated with covid-19.

inclusion criteria: willing and able to provide informed consent for the trial, written, electronic, verbal or other method deemed acceptable by the institution and irb. 18 years of age or older. if discharged from the hospital prior to study day 15 or if follow up is needed for study drug-related adverse event, willing to go to an outpatient facility if feasible or be in contact with the study team (phone call or other digital media) for remaining study assessments. laboratory-confirmed sars-cov-2 infection as determined by real time polymerase chain reaction (rt-pcr) or other food and drug administration (fda)-cleared commercial or public health assay. hospitalized (in patient with expected duration ≥ 24 hours) the effects of brequinar on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. men and women treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for 90 days after completion of brequinar administration. male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of brequinar. ≤ 10 days since first covid-19 symptom as determined by treating clinician. able to swallow capsules. at least one covid-19 symptom including but not limited to fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath, dyspnea, dysgeusia, or other symptom commonly associated with covid-19.

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: 1. willing and able to provide informed consent for the trial, written, electronic, verbal or other method deemed acceptable by the institution and irb. 2. 18 years of age or older. 3. if discharged from the hospital prior to study day 15 or if follow up is needed for study drug-related adverse event, willing to go to an outpatient facility if feasible or be in contact with the study team (phone call or other digital media) for remaining study assessments. 4. laboratory-confirmed sars-cov-2 infection as determined by real time polymerase chain reaction (rt-pcr) or other food and drug administration (fda)-cleared commercial or public health assay. 5. hospitalized (in patient with expected duration ≥ 24 hours) 6. the effects of brequinar on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. men and women treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for 90 days after completion of brequinar administration. 7. male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of brequinar. 8. ≤ 10 days since first covid-19 symptom as determined by treating clinician. 9. able to swallow capsules. 10. at least one covid-19 symptom including but not limited to fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath, dyspnea, dysgeusia, or other symptom commonly associated with covid-19.

inclusion criteria: 1. willing and able to provide informed consent for the trial, written, electronic, verbal or other method deemed acceptable by the institution and irb. 2. 18 years of age or older. 3. if discharged from the hospital prior to study day 15 or if follow up is needed for study drug-related adverse event, willing to go to an outpatient facility if feasible or be in contact with the study team (phone call or other digital media) for remaining study assessments. 4. laboratory-confirmed sars-cov-2 infection as determined by real time polymerase chain reaction (rt-pcr) or other food and drug administration (fda)-cleared commercial or public health assay. 5. hospitalized (in patient with expected duration ≥ 24 hours) 6. the effects of brequinar on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. men and women treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and for 90 days after completion of brequinar administration. 7. male subjects must agree to refrain from sperm donation from initial study drug administration until 90 days after the last dose of brequinar. 8. ≤ 10 days since first covid-19 symptom as determined by treating clinician. 9. able to swallow capsules. 10. at least one covid-19 symptom including but not limited to fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath, dyspnea, dysgeusia, or other symptom commonly associated with covid-19.