Created at Source Raw Value Validated value
June 25, 2021, 4:30 a.m. eu

1. Known history of allergic reactions to clofoctol or any of the excipients. 2. Known history of previous severe allergic reactions as anaphylaxis or Stevens-Johnson syndrome whatever the cause. 3. Active and persistent diarrhoea, defined as 3 or more loose or watery stools per day for more than 48 hours. 4. SpO2 ≤93%. 5. Score of 3 in any individual parameter of the National Early Warning Score, ie: a. Respiratory distress with respiratory rate ≥25 or ≤8 breaths/minute, b. Oral body temperature ≤35°C, c. Systolic blood pressure ≤90 or ≥220 mmHg, d. Heart rate ≤40 or ≥131 beats/minute. 6. Critically ill patients presenting with 1 of the following: a. Respiratory failure requiring to receive mechanical ventilation, b. Shock. 7. Pregnant or breastfeeding female patients. Women of childbearing potential should have a negative pregnancy test and agree to use a highly effective contraceptive method during the study (eg, oral contraceptive and condom, intra-uterine device and condom, diaphragm with spermicide and condom) and for up to 5 half-lives after the last investigational product (IP) administration. 8. Current participation in another interventional clinical study or participation in another interventional clinical study within 1 month prior to the first dose of IP in this study. 9. Patients having received 1 or more doses of vaccine against SARS-CoV-2. 10. Incarcerated patient.

1. Known history of allergic reactions to clofoctol or any of the excipients. 2. Known history of previous severe allergic reactions as anaphylaxis or Stevens-Johnson syndrome whatever the cause. 3. Active and persistent diarrhoea, defined as 3 or more loose or watery stools per day for more than 48 hours. 4. SpO2 ≤93%. 5. Score of 3 in any individual parameter of the National Early Warning Score, ie: a. Respiratory distress with respiratory rate ≥25 or ≤8 breaths/minute, b. Oral body temperature ≤35°C, c. Systolic blood pressure ≤90 or ≥220 mmHg, d. Heart rate ≤40 or ≥131 beats/minute. 6. Critically ill patients presenting with 1 of the following: a. Respiratory failure requiring to receive mechanical ventilation, b. Shock. 7. Pregnant or breastfeeding female patients. Women of childbearing potential should have a negative pregnancy test and agree to use a highly effective contraceptive method during the study (eg, oral contraceptive and condom, intra-uterine device and condom, diaphragm with spermicide and condom) and for up to 5 half-lives after the last investigational product (IP) administration. 8. Current participation in another interventional clinical study or participation in another interventional clinical study within 1 month prior to the first dose of IP in this study. 9. Patients having received 1 or more doses of vaccine against SARS-CoV-2. 10. Incarcerated patient.