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

inclusion criteria: * signed and dated written informed consent form (icf) to participate in the clinical study by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative. * male or non-pregnant female adults between 18 and 80 years of age, inclusive, at time of informed consent. * sars-cov-2 infection confirmed by positive standard polymerase chain reaction (pcr) test (or equivalent/ other approved diagnostic test) ≤ 4 days before randomization. * currently hospitalized and requiring medical care for covid-19. * moderate or severe covid-19, defined by respiratory function at screening, as below: * moderate, meets at least one of the following criteria: * peripheral oxygen saturation spo2 \> 93% on room air; * respiratory rate ≥ 20 to \< 30 breaths per minute. * severe, meets at least one of the following criteria: * peripheral oxygen saturation spo2 ≤ 93% on room air or arterial oxygen partial pressure (pao2) / fraction of inspired oxygen (fio2) \< 300mmhg (1mmhg=0.133kpa) \[corrective formulation should be used for higher altitude regions (over 1000m)\]; * respiratory rate ≥ 30 breaths per minute. * body mass index (bmi) of ≥18 to \<40kg/m2 at screening. * agrees to the collection of nasopharyngeal (np) swabs and venous blood per protocol. * in the opinion of the investigator, willing and able to comply with the study protocol assessments, and is committed to the study and the study follow up visits.

inclusion criteria: * signed and dated written informed consent form (icf) to participate in the clinical study by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative. * male or non-pregnant female adults between 18 and 80 years of age, inclusive, at time of informed consent. * sars-cov-2 infection confirmed by positive standard polymerase chain reaction (pcr) test (or equivalent/ other approved diagnostic test) ≤ 4 days before randomization. * currently hospitalized and requiring medical care for covid-19. * moderate or severe covid-19, defined by respiratory function at screening, as below: * moderate, meets at least one of the following criteria: * peripheral oxygen saturation spo2 \> 93% on room air; * respiratory rate ≥ 20 to \< 30 breaths per minute. * severe, meets at least one of the following criteria: * peripheral oxygen saturation spo2 ≤ 93% on room air or arterial oxygen partial pressure (pao2) / fraction of inspired oxygen (fio2) \< 300mmhg (1mmhg=0.133kpa) \[corrective formulation should be used for higher altitude regions (over 1000m)\]; * respiratory rate ≥ 30 breaths per minute. * body mass index (bmi) of ≥18 to \<40kg/m2 at screening. * agrees to the collection of nasopharyngeal (np) swabs and venous blood per protocol. * in the opinion of the investigator, willing and able to comply with the study protocol assessments, and is committed to the study and the study follow up visits.

March 7, 2021, 12:31 a.m. usa

inclusion criteria: - signed and dated written informed consent form (icf) to participate in the clinical study by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative. - male or non-pregnant female adults between 18 and 80 years of age, inclusive, at time of informed consent. - sars-cov-2 infection confirmed by positive standard polymerase chain reaction (pcr) test (or equivalent/ other approved diagnostic test) ≤ 4 days before randomization. - currently hospitalized and requiring medical care for covid-19. - moderate or severe covid-19, defined by respiratory function at screening, as below: - moderate, meets at least one of the following criteria: - peripheral oxygen saturation spo2 > 93% on room air; - respiratory rate ≥ 20 to < 30 breaths per minute. - severe, meets at least one of the following criteria: - peripheral oxygen saturation spo2 ≤ 93% on room air or arterial oxygen partial pressure (pao2) / fraction of inspired oxygen (fio2) < 300mmhg (1mmhg=0.133kpa) [corrective formulation should be used for higher altitude regions (over 1000m)]; - respiratory rate ≥ 30 breaths per minute. - body mass index (bmi) of ≥18 to <40kg/m2 at screening. - agrees to the collection of nasopharyngeal (np) swabs and venous blood per protocol. - in the opinion of the investigator, willing and able to comply with the study protocol assessments, and is committed to the study and the study follow up visits.

inclusion criteria: - signed and dated written informed consent form (icf) to participate in the clinical study by patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative. - male or non-pregnant female adults between 18 and 80 years of age, inclusive, at time of informed consent. - sars-cov-2 infection confirmed by positive standard polymerase chain reaction (pcr) test (or equivalent/ other approved diagnostic test) ≤ 4 days before randomization. - currently hospitalized and requiring medical care for covid-19. - moderate or severe covid-19, defined by respiratory function at screening, as below: - moderate, meets at least one of the following criteria: - peripheral oxygen saturation spo2 > 93% on room air; - respiratory rate ≥ 20 to < 30 breaths per minute. - severe, meets at least one of the following criteria: - peripheral oxygen saturation spo2 ≤ 93% on room air or arterial oxygen partial pressure (pao2) / fraction of inspired oxygen (fio2) < 300mmhg (1mmhg=0.133kpa) [corrective formulation should be used for higher altitude regions (over 1000m)]; - respiratory rate ≥ 30 breaths per minute. - body mass index (bmi) of ≥18 to <40kg/m2 at screening. - agrees to the collection of nasopharyngeal (np) swabs and venous blood per protocol. - in the opinion of the investigator, willing and able to comply with the study protocol assessments, and is committed to the study and the study follow up visits.