COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62988

Dr Kavita Singh

sudipto.roy@icmr.gov.in

2022-01-07

Not recruiting

RCT

Randomized

Adaptive

Open label

multi-center

Treatment

1. Male or female patients â?¥45 years of age at the time of screening AND having History of one or more of the following risk factors at screening as evidenced by previous medical records: Diabetes and/or heart diseases and/or chronic renal disease and/or Chronic Obstructive Pulmonary disease and/or cerebrovascular diseases and/or judged to be obese with BMI > 25 <br/ > OR <br/ > Male or female patients â?¥ 65 years of age without any co-morbidity <br/ > 2. COVID-19 confirmed by molecular biology or validated antigenic test available in India for SARS-Cov2 according to national guidelines, based on result within 24 hours prior to screening and maximum 48 hours after sampling. <br/ > 3. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) â?¥ 94%. <br/ > 4. Signed written consent from the patient <br/ > 5. Accepting and having the ability to be reached by telephone throughout the study <br/ > 6. Acceptability of using telemedicine platform through a application on mobile device <br/ > 7. Having designated a contact person who can be contacted in case of emergency.

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/ >

3

Drugs for Neglected Diseases Initiative DNDi

45

99

India

Mild disease at enrollment

1: Mild disease at enrollment

3000

Progression to moderate/severe COVID-19 defined as hospitalization due to COVID-19 illness and/orSpO2 â?¤ 93% on room air and/ or requiring hospital emergency visit due to COVID 19 acute medical illness; within 21 days after randomisation. <br/ >OR <br/ >Death for any reason within 21 days after randomisation. <br/ >Timepoint: Within 21 days after randomization

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 3

[{"arm_notes": "", "treatment_id": 2366, "treatment_name": "Artesunate-amodiaquine+ivermectin", "treatment_type": "Antimalarials+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1650, "treatment_name": "Ciclesonide+nitazoxanide", "treatment_type": "Corticosteroids+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]