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

inclusion criteria: 1. capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. study participant must be at least 18 years of age at the time of signing the icf 3. study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status \[3\] or \[4\]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. 4. body weight at least 50 kg and a body mass index (bmi) ≥ 18.0 kg/m2 and \< 40.0 kg/m2 5. male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1. she is not a wocbp 2. is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of \<1%, during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 7. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp. 1. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 2. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 3. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. a male study participant is eligible to participate if: 1. he is azoospermic 2. the partner is not a wocbp. 3. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of \<1%, during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 4. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

inclusion criteria: 1. capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. study participant must be at least 18 years of age at the time of signing the icf 3. study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status \[3\] or \[4\]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. 4. body weight at least 50 kg and a body mass index (bmi) ≥ 18.0 kg/m2 and \< 40.0 kg/m2 5. male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1. she is not a wocbp 2. is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of \<1%, during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 7. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp. 1. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 2. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 3. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. a male study participant is eligible to participate if: 1. he is azoospermic 2. the partner is not a wocbp. 3. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of \<1%, during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 4. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. study participant must be at least 18 years of age at the time of signing the icf study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status [3] or [4]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. body weight at least 50 kg and a body mass index (bmi) ≥ 18.0 kg/m2 and < 40.0 kg/m2 male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: she is not a wocbp is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. a male study participant is eligible to participate if: he is azoospermic the partner is not a wocbp. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

inclusion criteria: capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. study participant must be at least 18 years of age at the time of signing the icf study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status [3] or [4]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. body weight at least 50 kg and a body mass index (bmi) ≥ 18.0 kg/m2 and < 40.0 kg/m2 male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: she is not a wocbp is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. a male study participant is eligible to participate if: he is azoospermic the partner is not a wocbp. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

March 18, 2021, 12:31 a.m. usa

inclusion criteria: 1. capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. study participant must be at least 18 years of age at the time of signing the icf 3. study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status [3] or [4]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. 4. body weight at least 50 kg and a body mass index (bmi) ≥ 18.0 kg/m2 and < 40.0 kg/m2 5. male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1. she is not a wocbp 2. is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 7. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp. 1. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 2. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 3. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. a male study participant is eligible to participate if: 1. he is azoospermic 2. the partner is not a wocbp. 3. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 4. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

inclusion criteria: 1. capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. study participant must be at least 18 years of age at the time of signing the icf 3. study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status [3] or [4]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. 4. body weight at least 50 kg and a body mass index (bmi) ≥ 18.0 kg/m2 and < 40.0 kg/m2 5. male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1. she is not a wocbp 2. is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 7. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp. 1. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 2. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 3. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. a male study participant is eligible to participate if: 1. he is azoospermic 2. the partner is not a wocbp. 3. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 4. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

March 5, 2021, 12:31 a.m. usa

inclusion criteria: 1. capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. study participant must be at least 18 years of age at the time of signing the icf 3. study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status [3] or [4]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. 4. body weight at least 50 kg and have a body mass index (bmi) ≥ 18.0 kg/m2 and < 40.0 kg/m2 5. male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1. she is not a wocbp 2. is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 7. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp. 1. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 2. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 3. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. a male study participant is eligible to participate if: 1. he is azoospermic 2. the partner is not a wocbp. 3. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 4. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

inclusion criteria: 1. capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. study participant must be at least 18 years of age at the time of signing the icf 3. study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status [3] or [4]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. 4. body weight at least 50 kg and have a body mass index (bmi) ≥ 18.0 kg/m2 and < 40.0 kg/m2 5. male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1. she is not a wocbp 2. is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 7. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp. 1. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 2. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 3. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. a male study participant is eligible to participate if: 1. he is azoospermic 2. the partner is not a wocbp. 3. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 4. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

March 2, 2021, 12:31 a.m. usa

inclusion criteria: 1. capable of giving signed informed consent as described in section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. study participant must be at least 18 years of age at the time of signing the icf 3. study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status [3] or [4]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. 4. body weight at least 50 kg and have a body mass index (bmi) ≥ 18.0 kg/m2 and < 40.0 kg/m2 5. male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1. she is not a wocbp 2. is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in section 10.3.2 during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 7. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp, see section 8.3.5. 1. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 2. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 3. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. a male study participant is eligible to participate if: 1. he is azoospermic 2. the partner is not a wocbp as defined in section 10.3.1. 3. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in section 10.3.2 during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 4. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.

inclusion criteria: 1. capable of giving signed informed consent as described in section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. 2. study participant must be at least 18 years of age at the time of signing the icf 3. study participants with a laboratory confirmed diagnosis of sars-cov-2 infection presenting as moderate -to-severe covid-19 requiring hospitalization for covid-19 (clinical severity status [3] or [4]) and for medical reasons (see section 8). patients presenting to the hospital without a laboratory confirmed sars-cov-2 infection will be tested locally for sars-cov-2 during the screening period. for sites in the eu: a ce certified sars-cov-2 pcr test kit is required to confirm infection. for sites outside the eu: sars-cov-2 pcr test kits certified according to local regulations are required to confirm infection. 4. body weight at least 50 kg and have a body mass index (bmi) ≥ 18.0 kg/m2 and < 40.0 kg/m2 5. male or female contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 6. a female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: 1. she is not a wocbp 2. is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in section 10.3.2 during the imp period and for at least 4 weeks after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 7. a wocbp must have a negative urine pregnancy test within 24 hours before the first dose of imp, see section 8.3.5. 1. if a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 2. if a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. in such cases, the participant must not be randomized if the serum pregnancy result is positive. 3. the investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy. 8. a male study participant is eligible to participate if: 1. he is azoospermic 2. the partner is not a wocbp as defined in section 10.3.1. 3. the partner is a wocbp and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in section 10.3.2 during the imp period and for at least 90 days after the last dose of imp. the investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of imp. 4. he acknowledges that sperm donation is prohibited from the first dose of imp until at least 90 days after the last dose of imp.