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

1. the subject is a female who is breastfeeding or pregnant. 2. known hypersensitivity to eb05 or its excipients. 3. in the opinion of the investigator, death is imminent and inevitable or patient will be discharged within the next 48 - 72 hours, irrespective of the provision of treatment. 4. experiencing cardiac arrest while hospitalized with covid-19. 5. active participation in other immunomodulator or immunosuppressant drug clinical trials. a. participation in covid-19 antiviral, anticoagulant and convalescent plasma trials may be permitted; however, the decision to enroll a patient who is participating in other clinical trials will be dealt with on a case-by-case basis. 6. treatment with immunomodulator or immunosuppressant drugs, including but not limited to tnf inhibitors and anti-il-1 agents within 5 half-lives or 30 days (whichever is longer) before randomization. except for the following, which are permitted: 1. treatment with immunomodulator, or immunosuppressant drugs, such as corticosteroids, as part of soc for covid-19 2. transplant patients 7. known other clinical conditions that contraindicate eb05 and cannot be treated or solved according to the judgment of the clinician. 8. patient has been intubated or mechanically ventilated for more than 72 hours prior to administration of the investigational product. 9. patient has been intubated and then extubated during the current hospitalization prior to administration of the investigational product. 10. patient has experienced meaningful clinical improvement in the severity of disease prior to administration of the investigational product.

1. the subject is a female who is breastfeeding or pregnant. 2. known hypersensitivity to eb05 or its excipients. 3. in the opinion of the investigator, death is imminent and inevitable or patient will be discharged within the next 48 - 72 hours, irrespective of the provision of treatment. 4. experiencing cardiac arrest while hospitalized with covid-19. 5. active participation in other immunomodulator or immunosuppressant drug clinical trials. a. participation in covid-19 antiviral, anticoagulant and convalescent plasma trials may be permitted; however, the decision to enroll a patient who is participating in other clinical trials will be dealt with on a case-by-case basis. 6. treatment with immunomodulator or immunosuppressant drugs, including but not limited to tnf inhibitors and anti-il-1 agents within 5 half-lives or 30 days (whichever is longer) before randomization. except for the following, which are permitted: 1. treatment with immunomodulator, or immunosuppressant drugs, such as corticosteroids, as part of soc for covid-19 2. transplant patients 7. known other clinical conditions that contraindicate eb05 and cannot be treated or solved according to the judgment of the clinician. 8. patient has been intubated or mechanically ventilated for more than 72 hours prior to administration of the investigational product. 9. patient has been intubated and then extubated during the current hospitalization prior to administration of the investigational product. 10. patient has experienced meaningful clinical improvement in the severity of disease prior to administration of the investigational product.

Aug. 2, 2023, 8 p.m. usa

the subject is a female who is breastfeeding or pregnant. known hypersensitivity to eb05 or its excipients. in the opinion of the investigator, death is imminent and inevitable or patient will be discharged within the next 48 - 72 hours, irrespective of the provision of treatment. experiencing cardiac arrest while hospitalized with covid-19. active participation in other immunomodulator or immunosuppressant drug clinical trials. a. participation in covid-19 antiviral, anticoagulant and convalescent plasma trials may be permitted; however, the decision to enroll a patient who is participating in other clinical trials will be dealt with on a case-by-case basis. treatment with immunomodulator or immunosuppressant drugs, including but not limited to tnf inhibitors and anti-il-1 agents within 5 half-lives or 30 days (whichever is longer) before randomization. except for the following, which are permitted: treatment with immunomodulator, or immunosuppressant drugs, such as corticosteroids, as part of soc for covid-19 transplant patients known other clinical conditions that contraindicate eb05 and cannot be treated or solved according to the judgment of the clinician. patient has been intubated or mechanically ventilated for more than 72 hours prior to administration of the investigational product. patient has been intubated and then extubated during the current hospitalization prior to administration of the investigational product. patient has experienced meaningful clinical improvement in the severity of disease prior to administration of the investigational product.

the subject is a female who is breastfeeding or pregnant. known hypersensitivity to eb05 or its excipients. in the opinion of the investigator, death is imminent and inevitable or patient will be discharged within the next 48 - 72 hours, irrespective of the provision of treatment. experiencing cardiac arrest while hospitalized with covid-19. active participation in other immunomodulator or immunosuppressant drug clinical trials. a. participation in covid-19 antiviral, anticoagulant and convalescent plasma trials may be permitted; however, the decision to enroll a patient who is participating in other clinical trials will be dealt with on a case-by-case basis. treatment with immunomodulator or immunosuppressant drugs, including but not limited to tnf inhibitors and anti-il-1 agents within 5 half-lives or 30 days (whichever is longer) before randomization. except for the following, which are permitted: treatment with immunomodulator, or immunosuppressant drugs, such as corticosteroids, as part of soc for covid-19 transplant patients known other clinical conditions that contraindicate eb05 and cannot be treated or solved according to the judgment of the clinician. patient has been intubated or mechanically ventilated for more than 72 hours prior to administration of the investigational product. patient has been intubated and then extubated during the current hospitalization prior to administration of the investigational product. patient has experienced meaningful clinical improvement in the severity of disease prior to administration of the investigational product.

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

the subject is a female who is breastfeeding or pregnant. known hypersensitivity to eb05 or its excipients. mechanical ventilation (including venovenous ecmo) for ≥5 days (120 hours), or any duration of venoarterial ecmo. in the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. active participation in other drug clinical trials. treatment with immunomodulator or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) before randomization. (note treatment with immunomodulator or immunosuppressant drugs, such as corticosteroids, as part of soc, is permitted). known other clinical conditions that contraindicate eb05 and cannot be treated or solved according to the judgment of the clinician. possibility of the subject being transferred to a non-study hospital within 72h.

the subject is a female who is breastfeeding or pregnant. known hypersensitivity to eb05 or its excipients. mechanical ventilation (including venovenous ecmo) for ≥5 days (120 hours), or any duration of venoarterial ecmo. in the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. active participation in other drug clinical trials. treatment with immunomodulator or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) before randomization. (note treatment with immunomodulator or immunosuppressant drugs, such as corticosteroids, as part of soc, is permitted). known other clinical conditions that contraindicate eb05 and cannot be treated or solved according to the judgment of the clinician. possibility of the subject being transferred to a non-study hospital within 72h.

Jan. 14, 2021, 12:31 a.m. usa

1. the subject is a female who is breastfeeding or pregnant. 2. known hypersensitivity to eb05 or its excipients. 3. mechanical ventilation (including venovenous ecmo) for ≥5 days (120 hours), or any duration of venoarterial ecmo. 4. in the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. 5. active participation in other drug clinical trials. 6. treatment with immunomodulator or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) before randomization. (note treatment with immunomodulator or immunosuppressant drugs, such as corticosteroids, as part of soc, is permitted). 7. known other clinical conditions that contraindicate eb05 and cannot be treated or solved according to the judgment of the clinician. 8. possibility of the subject being transferred to a non-study hospital within 72h.

1. the subject is a female who is breastfeeding or pregnant. 2. known hypersensitivity to eb05 or its excipients. 3. mechanical ventilation (including venovenous ecmo) for ≥5 days (120 hours), or any duration of venoarterial ecmo. 4. in the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. 5. active participation in other drug clinical trials. 6. treatment with immunomodulator or immunosuppressant drugs, including but not limited to il-6 inhibitors, tnf inhibitors, anti-il-1 agents, and jak inhibitors within 5 half-lives or 30 days (whichever is longer) before randomization. (note treatment with immunomodulator or immunosuppressant drugs, such as corticosteroids, as part of soc, is permitted). 7. known other clinical conditions that contraindicate eb05 and cannot be treated or solved according to the judgment of the clinician. 8. possibility of the subject being transferred to a non-study hospital within 72h.

Oct. 26, 2020, 11:31 p.m. usa

1. subject is a female who is breastfeeding or pregnant. 2. known hypersensitivity to eb05 or its excipients. 3. mechanical ventilation (including venovenous ecmo) for ≥5 days, or any duration of venoarterial ecmo. 4. in the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. 5. participating in other drug clinical trials. • participation in covid-19 antiviral trials may be permitted; a list of permitted anti-virals will be provided at the time of study initiation and will reflect the state of research at that point in time as a guidance to investigators. however, decision to allow patients participating in other clinical trials will be dealt with on a case by case basis. 6. immunosuppression, defined as any of the following: - treatment with immunosuppressive agents for a non-covid-19-related condition; - chemotherapy within 30 days prior to inclusion or ongoing; - immunomodulatory drugs for a non-covid-19-related condition within 30 days prior to inclusion; - use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisolone 20 mg or equivalent per day for 4 weeks 7. known other active infections or other clinical condition that contraindicate eb05 and cannot be treated or solved according to the judgement of the clinician. 8. possibility of the subject being transferred to a non-study hospital within 72h.

1. subject is a female who is breastfeeding or pregnant. 2. known hypersensitivity to eb05 or its excipients. 3. mechanical ventilation (including venovenous ecmo) for ≥5 days, or any duration of venoarterial ecmo. 4. in the opinion of the investigator, death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. 5. participating in other drug clinical trials. • participation in covid-19 antiviral trials may be permitted; a list of permitted anti-virals will be provided at the time of study initiation and will reflect the state of research at that point in time as a guidance to investigators. however, decision to allow patients participating in other clinical trials will be dealt with on a case by case basis. 6. immunosuppression, defined as any of the following: - treatment with immunosuppressive agents for a non-covid-19-related condition; - chemotherapy within 30 days prior to inclusion or ongoing; - immunomodulatory drugs for a non-covid-19-related condition within 30 days prior to inclusion; - use of chronic oral corticosteroids for a non-covid-19-related condition in a dose higher than prednisolone 20 mg or equivalent per day for 4 weeks 7. known other active infections or other clinical condition that contraindicate eb05 and cannot be treated or solved according to the judgement of the clinician. 8. possibility of the subject being transferred to a non-study hospital within 72h.