Colchicine to Reduce COVID-19 Related complications in High Risk Patients Post COVID-19 Infectio

Phase 3

Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Registration Number: CTRI/2021/11/038234

Lead Sponsor: Dr Vivekanand Jha

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
et 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 Outcome Measures