Created at Source Raw Value Validated value
Feb. 25, 2022, noon oms

1. Abnormal physical examination findings: <br/ > -respiratory rate â?¥25 per minute. <br/ > -recurrent diarrhoea or vomiting episodes ( > 3 in the last 24 hours) <br/ > 2. Feeling unwell for more than 7 days prior to screening. <br/ > 3. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months. <br/ > 4. On-going treatment at screening with: <br/ > -chronic systemic 40 mg prednisolone or equivalent doses of other glucocorticoids <br/ > -immunosuppressive treatment, <br/ > 5. For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use. <br/ > 6. Unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g., no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the Investigator or cannot use an inhalation chamber. <br/ > 7. Any other reason that makes it impossible to monitor the patient during the study. <br/ > 8. Enrolled in other clinical trials with unregistered drugs or with registered drug which could interact with any of the study IPs or contra-indicated as concomitant treatment within the past 3 months prior screening. <br/ > 9. Known pulmonary arterial hypertension (PAH) or fibrosis. <br/ > 10. Use of concomitant medications that are contraindicated with any of the study treatment arms (please refer to Appendix 1) <br/ > 11. Know hypersensitivity to any of the study treatment arms or any other ingredient in their formulations <br/ > 12. Previous haematological event during treatment with Amodiaquine, <br/ > 13. Prior treatment with IVM within 6 months prior to screening <br/ > 14. Known macular degeneration, or other known retinal diseases, or 4-aminoquinolone-induced visual impairment (ASAQ) <br/ > 15. Known cirrhosis and/or jaundice due to IVM and amodiaquine <br/ > 16. Known renal impairment as clinically assessed or by blood analysis if available (ASAQ) <br/ > 17. Currently receiving, or recently received (within 30 days prior to randomization) treatment with any antimalarial drug (ASAQ) <br/ > 18. Pregnancy based on urine pregnancy test at screening or breast feeding for the ivermectin/ASAQ arm. <br/ >

1. Abnormal physical examination findings: <br/ > -respiratory rate â?¥25 per minute. <br/ > -recurrent diarrhoea or vomiting episodes ( > 3 in the last 24 hours) <br/ > 2. Feeling unwell for more than 7 days prior to screening. <br/ > 3. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months. <br/ > 4. On-going treatment at screening with: <br/ > -chronic systemic 40 mg prednisolone or equivalent doses of other glucocorticoids <br/ > -immunosuppressive treatment, <br/ > 5. For any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use. <br/ > 6. Unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g., no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the Investigator or cannot use an inhalation chamber. <br/ > 7. Any other reason that makes it impossible to monitor the patient during the study. <br/ > 8. Enrolled in other clinical trials with unregistered drugs or with registered drug which could interact with any of the study IPs or contra-indicated as concomitant treatment within the past 3 months prior screening. <br/ > 9. Known pulmonary arterial hypertension (PAH) or fibrosis. <br/ > 10. Use of concomitant medications that are contraindicated with any of the study treatment arms (please refer to Appendix 1) <br/ > 11. Know hypersensitivity to any of the study treatment arms or any other ingredient in their formulations <br/ > 12. Previous haematological event during treatment with Amodiaquine, <br/ > 13. Prior treatment with IVM within 6 months prior to screening <br/ > 14. Known macular degeneration, or other known retinal diseases, or 4-aminoquinolone-induced visual impairment (ASAQ) <br/ > 15. Known cirrhosis and/or jaundice due to IVM and amodiaquine <br/ > 16. Known renal impairment as clinically assessed or by blood analysis if available (ASAQ) <br/ > 17. Currently receiving, or recently received (within 30 days prior to randomization) treatment with any antimalarial drug (ASAQ) <br/ > 18. Pregnancy based on urine pregnancy test at screening or breast feeding for the ivermectin/ASAQ arm. <br/ >