Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Colchicine: Colchicine 0.5 mg tablets once (body weight =70 Kg) or twice
(body weight 70 kg) daily for 26 weeks
Control Intervention1: Placebo: Placebo tablets for 26 weeks
Control Int
Sponsors
Dr Vivekanand Jha
Eligibility
Inclusion criteria
Inclusion criteria: 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) -or- b) Elevated inflammatory markers above normal range high sensitivity CRP >2 mg/L -or- neutrophil/lymphocyte ratio >5
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net difference in change in 6-minute walk test from baseline to weeks 12, 26 and 52 (using random effects linear regression to account for repeated measurements)Timepoint: Week 12 26 and 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory outcomes: all-cause mortality, CVD mortality, myocardial infarction, coronary revascularisation, stroke, thromboembolism and all-cause hospitalisationTimepoint: Week 52;Net difference in change in CRPTimepoint: Week 12, 26 and 52;Net difference in change in Euro-Quality of life EQ-5D scoreTimepoint: Week 12, 26 and 52;Net difference in change in Generalised Anxiety Disorder-7 score; Patient Health Questionnaire-9 depression score; Chalder Fatigue Scale Timepoint: Week 12, 26 and 52;Net difference in change in high sensitive Troponin T, NT-proBNP, coagulation markers (e.g. D-dimer) and ferritin Timepoint: Week 12, 26 and 52;Net difference in change in inflammatory cytokines (e.g. IL-1ß, IL-6)Timepoint: Week 26 and 52;Net difference in change in oxygen saturation at rest, maximal desaturation and maximal heart rate during 6-minute walk tests Timepoint: Week 12, 26 and 52;Net difference in change in pulmonary vital capacity and diffusion capacityTimepoint: Week 26 and 52;Net difference in change in self-reported symptoms cough, fatigue, shortness of breath, headache, sore throat, muscle and body aches, reduced appetite, chest pain, palpitations, dizziness, loss of taste/smell Timepoint: Week 12, 26 and 52;Net difference in dyspnea scale (Borg)Timepoint: Week 12, 26 and 52 | — |
Countries
India
Contacts
Public ContactDr Vivekanand Jha
The George Institute For Global Health, India
Outcome results
None listed