Created at Source Raw Value Validated value
Nov. 26, 2021, 10:30 p.m. oms

1) Any previous experimental treatment for COVID-19 <br/ >2) Need for mechanical invasive or non-invasive ventilation <br/ >3) Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days)prior to COVID-19 diagnosis <br/ >4) Participation in any other interventional trial within 3 months prior to Visit 1 <br/ >5) Any of the following findings at Visit 1: <br/ >a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab) <br/ >b Positive pregnancy test (see Section 8.2.3). <br/ >6) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator <br/ >7) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial <br/ >8) Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I <br/ >9) Treatment with any of the medications listed below within 1 week prior to Visit 1: <br/ >a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnâ??s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates) <br/ >b. Warfarin <br/ >10) Pregnant or breast-feeding female subjects <br/ >11) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 <br/ >12) Male subjects not willing to use contraceptive methods as described in Section 5.3.1 <br/ >13) Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder).

1) Any previous experimental treatment for COVID-19 <br/ >2) Need for mechanical invasive or non-invasive ventilation <br/ >3) Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days)prior to COVID-19 diagnosis <br/ >4) Participation in any other interventional trial within 3 months prior to Visit 1 <br/ >5) Any of the following findings at Visit 1: <br/ >a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab) <br/ >b Positive pregnancy test (see Section 8.2.3). <br/ >6) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator <br/ >7) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial <br/ >8) Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I <br/ >9) Treatment with any of the medications listed below within 1 week prior to Visit 1: <br/ >a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnâ??s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates) <br/ >b. Warfarin <br/ >10) Pregnant or breast-feeding female subjects <br/ >11) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 <br/ >12) Male subjects not willing to use contraceptive methods as described in Section 5.3.1 <br/ >13) Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder).

Nov. 13, 2021, 5:33 p.m. oms

N/A

N/A

Oct. 26, 2020, 8:29 a.m. oms

1) Any previous experimental treatment for COVID-19 <br/ >2) Need for mechanical invasive or non-invasive ventilation <br/ >3) Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days)prior to COVID-19 diagnosis <br/ >4) Participation in any other interventional trial within 3 months prior to Visit 1 <br/ >5) Any of the following findings at Visit 1: <br/ >a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab) <br/ >b Positive pregnancy test (see Section 8.2.3). <br/ >6) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator <br/ >7) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial <br/ >8) Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I <br/ >9) Treatment with any of the medications listed below within 1 week prior to Visit 1: <br/ >a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnâ??s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates) <br/ >b. Warfarin <br/ >10) Pregnant or breast-feeding female subjects <br/ >11) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 <br/ >12) Male subjects not willing to use contraceptive methods as described in Section 5.3.1 <br/ >13) Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder).

1) Any previous experimental treatment for COVID-19 <br/ >2) Need for mechanical invasive or non-invasive ventilation <br/ >3) Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days)prior to COVID-19 diagnosis <br/ >4) Participation in any other interventional trial within 3 months prior to Visit 1 <br/ >5) Any of the following findings at Visit 1: <br/ >a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab) <br/ >b Positive pregnancy test (see Section 8.2.3). <br/ >6) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator <br/ >7) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial <br/ >8) Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I <br/ >9) Treatment with any of the medications listed below within 1 week prior to Visit 1: <br/ >a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnâ??s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates) <br/ >b. Warfarin <br/ >10) Pregnant or breast-feeding female subjects <br/ >11) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 <br/ >12) Male subjects not willing to use contraceptive methods as described in Section 5.3.1 <br/ >13) Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder).