Created at Source Raw Value Validated value
March 14, 2021, 12:31 a.m. usa

- clinical signs indicative of covid-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air - treatment with a therapeutic agent against sars-cov-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against sars cov-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening - requirement, in the opinion of the investigator, for any of the prohibited medications during the study - use of hydroxychloroquine or amiodarone within 7 days of screening - pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of at-527. women of childbearing potential must have a negative urine pregnancy test result at screening - abnormal laboratory test results at screening - clinically significant abnormal ecg, as determined by the investigator, at screening - planned procedure or surgery during the study - known allergy or hypersensitivity to study drug or drug product excipients - substance abuse, as determined by the investigator, within 12 months prior to screening - poor peripheral venous access - malabsorption syndrome or other condition that would interfere with enteral absorption - any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion - history of anaphylaxis - any uncontrolled serious medical condition or other clinically significant abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

- clinical signs indicative of covid-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air - treatment with a therapeutic agent against sars-cov-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against sars cov-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening - requirement, in the opinion of the investigator, for any of the prohibited medications during the study - use of hydroxychloroquine or amiodarone within 7 days of screening - pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of at-527. women of childbearing potential must have a negative urine pregnancy test result at screening - abnormal laboratory test results at screening - clinically significant abnormal ecg, as determined by the investigator, at screening - planned procedure or surgery during the study - known allergy or hypersensitivity to study drug or drug product excipients - substance abuse, as determined by the investigator, within 12 months prior to screening - poor peripheral venous access - malabsorption syndrome or other condition that would interfere with enteral absorption - any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion - history of anaphylaxis - any uncontrolled serious medical condition or other clinically significant abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

Jan. 16, 2021, 12:31 a.m. usa

- clinical signs indicative of covid-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air - presence of any of the following risk factors for severe covid-19 illness: obesity (body mass index ≥30 kg/m2), chronic kidney disease, chronic obstructive pulmonary disease, asthma, heart conditions (e.g., heart failure, coronary artery disease, cardiomyopathies), hypertension, diabetes, liver disease, hematological disorders, or immunosuppression - treatment with a therapeutic agent against sars-cov-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against sars cov-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening - concurrent infection requiring systemic antiviral or antibacterial therapy at screening - requirement, in the opinion of the investigator, for any of the prohibited medications during the study - use of hydroxychloroquine or amiodarone within 7 days of screening - pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of at-527. women of childbearing potential must have a negative urine pregnancy test result at screening - planned procedure or surgery during the study - active cancer at any site - history of organ transplant - known history of hepatitis c - known history of hepatitis b - known hiv infection - known allergy or hypersensitivity to study drug or drug product excipients - current smoker, or former smoker with a smoking history of ≥10 pack-years - substance abuse, as determined by the investigator, within 12 months prior to screening - poor peripheral venous access - malabsorption syndrome or other condition that would interfere with enteral absorption - for cohorts b-e only: active psychiatric disease requiring treatment, or history of any psychiatric disorder, which, in the investigator's judgment, could deteriorate during the 14 day residential stay period of the study - any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion - history of anaphylaxis - any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study

- clinical signs indicative of covid-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate ≥30, heart rate ≥125, peripheral capillary oxygen saturation ≤93% on room air - presence of any of the following risk factors for severe covid-19 illness: obesity (body mass index ≥30 kg/m2), chronic kidney disease, chronic obstructive pulmonary disease, asthma, heart conditions (e.g., heart failure, coronary artery disease, cardiomyopathies), hypertension, diabetes, liver disease, hematological disorders, or immunosuppression - treatment with a therapeutic agent against sars-cov-2 including, but not limited to, other direct acting antivirals, convalescent plasma, monoclonal antibodies against sars cov-2, or intravenous immunoglobulin within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to screening - concurrent infection requiring systemic antiviral or antibacterial therapy at screening - requirement, in the opinion of the investigator, for any of the prohibited medications during the study - use of hydroxychloroquine or amiodarone within 7 days of screening - pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of at-527. women of childbearing potential must have a negative urine pregnancy test result at screening - planned procedure or surgery during the study - active cancer at any site - history of organ transplant - known history of hepatitis c - known history of hepatitis b - known hiv infection - known allergy or hypersensitivity to study drug or drug product excipients - current smoker, or former smoker with a smoking history of ≥10 pack-years - substance abuse, as determined by the investigator, within 12 months prior to screening - poor peripheral venous access - malabsorption syndrome or other condition that would interfere with enteral absorption - for cohorts b-e only: active psychiatric disease requiring treatment, or history of any psychiatric disorder, which, in the investigator's judgment, could deteriorate during the 14 day residential stay period of the study - any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion - history of anaphylaxis - any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study