Colchicine to Reduce Coronavirus Disease-19 Related Inflammation and Cardiovascular Complications in High Risk Patients Post-Acute Infection With SARS-COV-2 - A Randomized Controlled Trial

Dr Vivekanand Jha0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

研究概览

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•1. Age =18 years.
•2 Individuals who had clinically confirmed COVID-19,22 days since diagnosis prior to the date of randomization.
•3. Presence of either
•a) Post-COVID-19 Functional Status (PCFS) grade 2 or more. (higher number indicates poorer status)
•b) Elevated inflammatory markers above normal range
•high sensitivity CRP >2 mg/L
•neutrophil/lymphocyte ratio >5

•1. Definite indication for colchicine, such as gout or pericarditis
•2. Contraindication to colchicine, including:
•a. Hypersensitivity.
•b. Pregnant, breastfeeding or of childbearing age and not using an acceptable method of
•contraception.
•c. Currently taking or might need during the trial, a concomitant treatment which is contraindicated with colchicine: cyclosporin, strong CYP3A4 inhibitors, phenylbutazone, immunosuppressants and anti-neoplastic agents.
•3. Current/history of inflammatory bowel disease, chronic diarrhea, blood dyscrasias or
•eGFR <15mL/min/1.73m2.
•4. Current surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of trial drugs such as prior major gastrointestinal tract surgery (e.g. gastrectomy, lap band, or bowel resection).
•5. History of alcohol or drug dependence within 12 months.
•6. Significant cognitive impairment precluding consent

发起方

Dr Vivekanand Jha