A clinical trial to study the effects of several commercially available drugs in patients with mild COVID-19.
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2022/01/039235
- Lead Sponsor
- Drugs for Neglected Diseases Initiative DNDi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 0
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
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 < 3 months.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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/ ><br>OR <br/ ><br>Death for any reason within 21 days after randomisation. <br/ ><br>Timepoint: Within 21 days after randomization
- Secondary Outcome Measures
Name Time Method