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

the subject will be excluded from the study if any of the following applies: 1. no symptoms or signs or lung imaging abnormalities of sars-cov-2. 2. on or clinically diagnosed as requiring intubation at screening. 3. on or clinically diagnosed as requiring mechanical ventilation at screening. 4. on or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen ≥ 0.5). 5. on or clinically diagnosed as requiring noninvasive positive pressure ventilation. 6. on or clinically diagnosed as requiring extracorporeal membrane oxygenation (ecmo). 7. unable to swallow study capsules easily. 8. known allergic reaction or intolerant to fish or fish oils. 9. known allergic reaction to excipients of imp. 10. pregnant or breast-feeding at screening. 11. taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. 12. taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study. 13. used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to screening. 14. participating in other clinical studies at the same time. 15. evidence of multi-organ failure, sofa score \> 9. 16. deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. 17. deemed, by the investigator, likely to require transfer to the intensive care unit (icu) or unlikely to survive for at least 48 hours. 18. any gastro-intestinal symptoms at screening considered clinically significant. 19. clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.

the subject will be excluded from the study if any of the following applies: 1. no symptoms or signs or lung imaging abnormalities of sars-cov-2. 2. on or clinically diagnosed as requiring intubation at screening. 3. on or clinically diagnosed as requiring mechanical ventilation at screening. 4. on or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 l/min with fraction of delivered oxygen ≥ 0.5). 5. on or clinically diagnosed as requiring noninvasive positive pressure ventilation. 6. on or clinically diagnosed as requiring extracorporeal membrane oxygenation (ecmo). 7. unable to swallow study capsules easily. 8. known allergic reaction or intolerant to fish or fish oils. 9. known allergic reaction to excipients of imp. 10. pregnant or breast-feeding at screening. 11. taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. 12. taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study. 13. used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to screening. 14. participating in other clinical studies at the same time. 15. evidence of multi-organ failure, sofa score \> 9. 16. deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. 17. deemed, by the investigator, likely to require transfer to the intensive care unit (icu) or unlikely to survive for at least 48 hours. 18. any gastro-intestinal symptoms at screening considered clinically significant. 19. clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.

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

the subject will be excluded from the study if any of the following applies: no symptoms or signs or lung imaging abnormalities of sars-cov-2. on or clinically diagnosed as requiring intubation at screening. on or clinically diagnosed as requiring mechanical ventilation at screening. on or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5). on or clinically diagnosed as requiring noninvasive positive pressure ventilation. on or clinically diagnosed as requiring extracorporeal membrane oxygenation (ecmo). unable to swallow study capsules easily. known allergic reaction or intolerant to fish or fish oils. known allergic reaction to excipients of imp. pregnant or breast-feeding at screening. taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study. used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to screening. participating in other clinical studies at the same time. evidence of multi-organ failure, sofa score > 9. deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. deemed, by the investigator, likely to require transfer to the intensive care unit (icu) or unlikely to survive for at least 48 hours. any gastro-intestinal symptoms at screening considered clinically significant. clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.

the subject will be excluded from the study if any of the following applies: no symptoms or signs or lung imaging abnormalities of sars-cov-2. on or clinically diagnosed as requiring intubation at screening. on or clinically diagnosed as requiring mechanical ventilation at screening. on or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5). on or clinically diagnosed as requiring noninvasive positive pressure ventilation. on or clinically diagnosed as requiring extracorporeal membrane oxygenation (ecmo). unable to swallow study capsules easily. known allergic reaction or intolerant to fish or fish oils. known allergic reaction to excipients of imp. pregnant or breast-feeding at screening. taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study. used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to screening. participating in other clinical studies at the same time. evidence of multi-organ failure, sofa score > 9. deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. deemed, by the investigator, likely to require transfer to the intensive care unit (icu) or unlikely to survive for at least 48 hours. any gastro-intestinal symptoms at screening considered clinically significant. clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.

Nov. 3, 2020, 11:31 p.m. usa

the subject will be excluded from the study if any of the following applies: 1. no symptoms or signs or lung imaging abnormalities of sars-cov-2. 2. on or clinically diagnosed as requiring intubation at screening. 3. on or clinically diagnosed as requiring mechanical ventilation at screening. 4. on or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5). 5. on or clinically diagnosed as requiring noninvasive positive pressure ventilation. 6. on or clinically diagnosed as requiring extracorporeal membrane oxygenation (ecmo). 7. unable to swallow study capsules easily. 8. known allergic reaction or intolerant to fish or fish oils. 9. known allergic reaction to excipients of imp. 10. pregnant or breast-feeding at screening. 11. taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. 12. taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study. 13. used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to screening. 14. participating in other clinical studies at the same time. 15. evidence of multi-organ failure, sofa score > 9. 16. deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. 17. deemed, by the investigator, likely to require transfer to the intensive care unit (icu) or unlikely to survive for at least 48 hours. 18. any gastro-intestinal symptoms at screening considered clinically significant. 19. clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.

the subject will be excluded from the study if any of the following applies: 1. no symptoms or signs or lung imaging abnormalities of sars-cov-2. 2. on or clinically diagnosed as requiring intubation at screening. 3. on or clinically diagnosed as requiring mechanical ventilation at screening. 4. on or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 l/min with fraction of delivered oxygen ≥ 0.5). 5. on or clinically diagnosed as requiring noninvasive positive pressure ventilation. 6. on or clinically diagnosed as requiring extracorporeal membrane oxygenation (ecmo). 7. unable to swallow study capsules easily. 8. known allergic reaction or intolerant to fish or fish oils. 9. known allergic reaction to excipients of imp. 10. pregnant or breast-feeding at screening. 11. taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. 12. taking immunomodulators/immunosuppressants, including corticosteroids on entry into the study. 13. used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to screening. 14. participating in other clinical studies at the same time. 15. evidence of multi-organ failure, sofa score > 9. 16. deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. 17. deemed, by the investigator, likely to require transfer to the intensive care unit (icu) or unlikely to survive for at least 48 hours. 18. any gastro-intestinal symptoms at screening considered clinically significant. 19. clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.

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

the subject will be excluded from the study if any of the following applies: 1. subjects intubated prior to administration of imp. 2. subjects requiring mechanical ventilation at screening. 3. subjects who are unable to swallow capsules easily. 4. known allergic reaction or intolerant to fish or fish oils. 5. known allergic reaction to excipients of imp. 6. subjects who are pregnant or breast-feeding at screening. 7. subjects who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. 8. subjects taking warfarin or other anti-coagulants. 9. subjects taking immunomodulators/immunosuppressants (including corticosteroids) 10. subjects who have used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to screening. 11. subjects who are participating in other clinical studies at the same time. 12. evidence of multi-organ failure. 13. subjects with a do not resuscitate code. 14. subject is deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. 15. subject is deemed, by the investigator, likely to require transfer to the intensive care unit (icu) or unlikely to survive for at least 48 hours. 16. subjects with any laboratory tests from samples taken at screening considered clinically significant.

the subject will be excluded from the study if any of the following applies: 1. subjects intubated prior to administration of imp. 2. subjects requiring mechanical ventilation at screening. 3. subjects who are unable to swallow capsules easily. 4. known allergic reaction or intolerant to fish or fish oils. 5. known allergic reaction to excipients of imp. 6. subjects who are pregnant or breast-feeding at screening. 7. subjects who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. 8. subjects taking warfarin or other anti-coagulants. 9. subjects taking immunomodulators/immunosuppressants (including corticosteroids) 10. subjects who have used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to screening. 11. subjects who are participating in other clinical studies at the same time. 12. evidence of multi-organ failure. 13. subjects with a do not resuscitate code. 14. subject is deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol. 15. subject is deemed, by the investigator, likely to require transfer to the intensive care unit (icu) or unlikely to survive for at least 48 hours. 16. subjects with any laboratory tests from samples taken at screening considered clinically significant.