Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Nitazoxanide and Ciclesonide: 2000 mg nitazoxanide daily, divided into two daily intakes of two tablets of nitazoxanide 500 mg taken 12 hours apart with a meal for 14 days and 640 mcg C
Sponsors
Drugs for Neglected Diseases Initiative DNDi
Qascent Research Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients >=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 OR Male or female patients >= 65 years of age without any co-morbidity 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. 3. Viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (SpO2) >= 94%. 4. Signed written consent from the patient 5. Accepting and having the ability to be reached by telephone throughout the study 6. Acceptability of using telemedicine platform through a application on mobile device 7. Having designated a contact person who can be contacted in case of emergency. 8. Not vaccinated or partially vaccinated one dose of vaccine 9. Fully vaccinated (based on Manufacturer SmPC) with last dose >6 months prior to randomization 10. Known positive Covid-19 infection >6 months prior to randomization
Exclusion criteria
Exclusion criteria: 1. Abnormal physical examination findings: -respiratory rate >=25 per minute. -recurrent diarrhoea or vomiting episodes ( > 3 in the last 24 hours) 2. Feeling unwell for more than 7 days prior to screening. 3. End-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy 4. On-going treatment at screening with: -chronic systemic 40 mg prednisolone or equivalent doses of other glucocorticoids -immunosuppressive treatment; 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. 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. 7. Any other reason that makes it impossible to monitor the patient during the study. 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. 9. Known pulmonary arterial hypertension (PAH) or fibrosis. 10. Use of concomitant medications that are contraindicated with any of the study treatment arms (please refer to Appendix 1) 11. Know hypersensitivity to any of the study treatment arms or any other ingredient in their formulations 12. Previous haematological event during treatment with Amodiaquine, 13. Prior treatment with IVM within 6 months prior to screening 14. Known macular degeneration, or other known retinal diseases, or 4-aminoquinolone-induced visual impairment (ASAQ) 15. Known cirrhosis and/or jaundice due to IVM and amodiaquine 16. Known renal impairment as clinically assessed or by blood analysis if available (ASAQ) 17. Currently receiving, or recently received (within 30 days prior to randomization) treatment with any antimalarial drug (ASAQ) 18. Pregnancy based on urine pregnancy test at screening or breast feeding for the ivermectin/ASAQ arm. 19. Having received a vaccine booster dose anytime prior to randomisation 20. Use of concomitant medications that are contraindicated with fluoxetine, known hypersensitivity to fluoxetine or any other ingredient in the formulation. 21. Use of concomitant medications that are contraindicated with budesonide, known hypersensitivity to budesonide or any other ingredient in the formulation. 22. Patients with known suicidal ideation, severe psychiatric disorders or major uncontrolled depression or controlled with any of the prohibited drugs (see appendix 1.4) (fluoxetine) 23. History of known severe ventricular cardiac arrhythmia (ventricular tachycardia, patients with ventricular fibrillation recovered) or Long QT Syndrome (fluoxetine) 24. Prior treatment with any antiviral within 2 weeks prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. OR Death for any reason within 21 days after randomisation. Timepoint: Within 21 days after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free status: disease-free based on normalisation of pre-existing symptoms (based on mMRC scale, scale of Clinical progression and clinical symptoms) and SpO2 â?¥ 94% at Day 21 and no hospitalisation for COVID-19Timepoint: Within 21 days;Failure rate for each study armTimepoint: Within 21 days;Mean number and incidence rate of serious adverse events (SAEs)Timepoint: Within 21 days;Mean number and incidence rate of severe adverse eventsTimepoint: Within 21 days;Mean number of discontinuations or temporary suspensions of IPTimepoint: Within 14 days;Number of hospitalisations due to moderate/severe progressionTimepoint: Within 21 days;Number of hospitalizations due to other reason than progression of COVID-19Timepoint: Within 21 days;Occurrence of deathTimepoint: Within 21 days;Occurrence of SpO2 â?¤ 93% or death or hospitalisation due to COVID-19Timepoint: Within 21 days;Sub-group analysis of failure rate for each study armTimepoint: Within 21 days;Time to hospitalisationTimepoint: Within 21 days;Time to worsening of SpO2 â?¤ 93% within 21 daysTimepoint: Within 21 days | — |
Countries
India
Contacts
Public ContactDr Kavita Singh
Indian Council of Medical Research (ICMR)
Outcome results
None listed