Anti-Coronavirus Therapies (ACT)

Phase 3

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

• Registration Number: CTRI/2021/08/035909
• Lead Sponsor: Population Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Symptomatic and RTPCR positive confirmed diagnosis of mild COVID-19. Mild disease is defined as per Government of India guidelines as follows:

� Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache.

� Without evidence of breathlessness or hypoxia (normal saturation)

� Managed at COVID care center (or quarantined at home as per revised guidelines for home isolation: https://www.mohfw.gov.in/pdf/RevisedHomeIsolationGuidelines.pdf).

2) Age �18 years.

3) High risk: either age �70 or at least one of the following: male; obesity (BMI �30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes).

4) Within 7 days (ideally 72 hours) of diagnosis, or worsening clinically.

Additional details:

ââ?¬Â¢ The patients need to be recruited from fever clinic or from the hospitalââ?¬•s community care center.

� Baseline lab tests for blood count and serum creatinine to confirm eligibility need to be done

� Height and weight should be assessed at the time of recruitment

Exclusion Criteria

1) Kidney disease (eGFR <15 mL/min/1.73m2); liver disease; pregnancy or lactation.

2) Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitor, systemic azole antifungal, or macrolide antibiotic (except azithromycin).

3) Aspirin: allergy or planned use; high risk of bleeding, current or planned use of other anti-thrombotic drugs (e.g., P2Y12 inhibitors, direct oral anticoagulants, vitamin K antagonists, heparins).

4)(Patients >70 years, with known chronic kidney disease, or with a history of diabetes for more than 10 years should get creatinine [eGFR] tested within 72 hours of randomization)

Additional details:

�· Serum creatinine value needs to be obtained for all patients before enrolment. Those patients with a calculated eGFR < 15mLl/min/1.73m2 should be excluded. A normal creatinine value estimated within the previous 90 days will be acceptable as a baseline value. However, in such cases, the creatinine should be repeated within three days of randomization.

�·Baseline liver function test to be done to rule out liver disease.

�·Urine pregnancy test (in women in reproductive age group) to be done to rule out pregnancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified