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

inclusion criteria: 1. ≥18 years old, male or female. 2. subjects hospitalized with moderate to severe covid-19 with a category 4 or 5 on an 8-category ordinal scale. 3. has laboratory-confirmed covid-19 infection within 5 days prior to randomization. 4. initial covid-19 symptom onset within 5 days prior to randomization and ≥1 sign/symptom attributable to covid-19 within 24 hours before randomization. 5. the underlying medical condition was well controlled prior to sars cov 2 infection and does not affect daily life. 6. subject who did not receive covid 19 (primary series or booster) vaccine within the 6 months prior to screening. 7. the subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee. 8. the subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study. 9. the subject is able to understand the nature of the study and any potential hazards associated with participating in it. 10. negative pregnancy test for female subjects of childbearing potential and female subjects less than 2 years of postmenopause. women of childbearing potential (wocbp) and women of non-childbearing potential are eligible to participate. both women of childbearing potential and women of non-childbearing potential must use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 30 days after taking the last dose of fb2001.

inclusion criteria: 1. ≥18 years old, male or female. 2. subjects hospitalized with moderate to severe covid-19 with a category 4 or 5 on an 8-category ordinal scale. 3. has laboratory-confirmed covid-19 infection within 5 days prior to randomization. 4. initial covid-19 symptom onset within 5 days prior to randomization and ≥1 sign/symptom attributable to covid-19 within 24 hours before randomization. 5. the underlying medical condition was well controlled prior to sars cov 2 infection and does not affect daily life. 6. subject who did not receive covid 19 (primary series or booster) vaccine within the 6 months prior to screening. 7. the subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee. 8. the subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study. 9. the subject is able to understand the nature of the study and any potential hazards associated with participating in it. 10. negative pregnancy test for female subjects of childbearing potential and female subjects less than 2 years of postmenopause. women of childbearing potential (wocbp) and women of non-childbearing potential are eligible to participate. both women of childbearing potential and women of non-childbearing potential must use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 30 days after taking the last dose of fb2001.

Jan. 6, 2023, 8 p.m. usa

inclusion criteria: ≥18 years old, male or female. subjects hospitalized with moderate to severe covid-19 with a category 4 or 5 on an 8-category ordinal scale. has laboratory-confirmed covid-19 infection within 5 days prior to randomization. initial covid-19 symptom onset within 5 days prior to randomization and ≥1 sign/symptom attributable to covid-19 within 24 hours before randomization. the underlying medical condition was well controlled prior to sars cov 2 infection and does not affect daily life. subject who did not receive covid 19 (primary series or booster) vaccine within the 6 months prior to screening. the subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee. the subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study. the subject is able to understand the nature of the study and any potential hazards associated with participating in it. negative pregnancy test for female subjects of childbearing potential and female subjects less than 2 years of postmenopause. women of childbearing potential (wocbp) and women of non-childbearing potential are eligible to participate. both women of childbearing potential and women of non-childbearing potential must use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 30 days after taking the last dose of fb2001.

inclusion criteria: ≥18 years old, male or female. subjects hospitalized with moderate to severe covid-19 with a category 4 or 5 on an 8-category ordinal scale. has laboratory-confirmed covid-19 infection within 5 days prior to randomization. initial covid-19 symptom onset within 5 days prior to randomization and ≥1 sign/symptom attributable to covid-19 within 24 hours before randomization. the underlying medical condition was well controlled prior to sars cov 2 infection and does not affect daily life. subject who did not receive covid 19 (primary series or booster) vaccine within the 6 months prior to screening. the subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee. the subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study. the subject is able to understand the nature of the study and any potential hazards associated with participating in it. negative pregnancy test for female subjects of childbearing potential and female subjects less than 2 years of postmenopause. women of childbearing potential (wocbp) and women of non-childbearing potential are eligible to participate. both women of childbearing potential and women of non-childbearing potential must use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 30 days after taking the last dose of fb2001.

July 8, 2022, midnight usa

inclusion criteria: ≥18 years old, male or female. subjects hospitalized with moderate to severe covid-19 with a category 4 or 5 on an 8-category ordinal scale. has laboratory-confirmed covid-19 infection within 5 days prior to randomization. initial covid-19 symptom onset within 5 days prior to randomization and ≥1 sign/symptom attributable to covid-19 within 24 hours before randomization. has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from covid-19, and that was well controlled prior to sars-cov-2 infection and does not affect daily life. subject who did not receive covid 19 (primary series or booster) vaccine within the 6 months prior to screening. the subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee. the subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study. the subject is able to understand the nature of the study and any potential hazards associated with participating in it. negative pregnancy test for female subjects of childbearing potential. women of childbearing potential (wocbp) and women of non-childbearing potential are eligible to participate. both women of childbearing potential and women of non-childbearing potential must use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 30 days after taking the last dose of fb2001.

inclusion criteria: ≥18 years old, male or female. subjects hospitalized with moderate to severe covid-19 with a category 4 or 5 on an 8-category ordinal scale. has laboratory-confirmed covid-19 infection within 5 days prior to randomization. initial covid-19 symptom onset within 5 days prior to randomization and ≥1 sign/symptom attributable to covid-19 within 24 hours before randomization. has at least 1 characteristic or underlying medical condition associated with an increased risk of severe illness from covid-19, and that was well controlled prior to sars-cov-2 infection and does not affect daily life. subject who did not receive covid 19 (primary series or booster) vaccine within the 6 months prior to screening. the subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided and has had the opportunity to discuss the study with the investigator or designee. the subject is able to communicate satisfactorily with the investigator and to participate in, and comply with, the requirements of the study. the subject is able to understand the nature of the study and any potential hazards associated with participating in it. negative pregnancy test for female subjects of childbearing potential. women of childbearing potential (wocbp) and women of non-childbearing potential are eligible to participate. both women of childbearing potential and women of non-childbearing potential must use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 30 days after taking the last dose of fb2001.