CTRI/2022/01/039235Other3 期
An open-label, multicentre, randomised, adaptive platform trial of the safety and efficacy of several therapies, including antiviral therapies, versus control in mild cases of COVID-19 - ANTICOV INDIA
试验速览
- 阶段
- 3 期
- 状态
- Other
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- •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
排除标准
- •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
研究者
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