COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61494

Dr Vivekanand Jha

vjha@georgeinstitute.org.in

2021-11-24

Not recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Long covid

1. Provided signed informed consent. <br/ > 2. Previously confirmed diagnosis of SARS-CoV-2 infection (polymerase chain reaction or IgG antibody) between 22 to 100 days prior to the date of randomization with negative test at trial entry screening. <br/ > 3. >3 weeks and < 6 months from symptom onset <br/ > 4. Persistent symptoms defined as either dyspnoea, chest pain, palpitations and/or fatigue. <br/ > 5. Elevated inflammatory markers above normal range (e.g. high sensitivity CRP >2 mg/L or <br/ > neutrophil/lymphocyte ratio >5).

1. Definite indication for colchicine, such as gout or pericarditis <br/ > 2. Contraindication to colchicine, including: <br/ > a. Hypersensitivity. <br/ > b. Pregnant, breastfeeding or of childbearing age and not using an acceptable method of <br/ > contraception. <br/ > 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. <br/ > 3. Current/history of inflammatory bowel disease, chronic diarrhea, blood dyscrasias or <br/ > eGFR <15mL/min/1.73m2. <br/ > 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). <br/ > 5. History of alcohol or drug dependence within 12 months. <br/ > 6. Significant cognitive impairment precluding consent

2

Dr Vivekanand Jha

18

99

India

Patients recovered from covid

N/A

350

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

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 3

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]