Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection

University of Baghdad

Status and phase: Completed; Phase 1

Conditions: COVID-19 Pandemic

Treatments: Drug: Colchicine 0.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05151614

PRO21230003

Details and patient eligibility

About

The study included 2 arms Colchicine group: Colchicine + standard therapy of COVID-19 Control group: Standard therapy of COVID-19

Full description

This study will be a randomized controlled trial with 2 arms study trial 1:1 allocation. The sample size was calculated and we need a total of 160 patients (80 Colchicine add on group and 80 controls)

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with age above 18 years and of any gender 2. Definite diagnosis of COVID-19 according to the WHO classification criteria 3. Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases 4. Understands and agrees to comply with planned study procedures.

Exclusion criteria

1. Patients refuse to enrol in the study
2. Patients with hypersensitivity to colchicine
3. Patients with chronic diseases: Renal failure with eGFR<30 ml/min; chronic liver disease with hepatic failure (AST/ALT > 3x normal).; decompensated heart failure, long QT syndrome (QTc >450 msec.), and uncontrolled arrhythmia; inflammatory bowel disease, chronic diarrhea or malabsorption; pre-existent progressive neuromuscular disease, and Metastatic cancer
4. Pregnancy and breast feeding
5. Medications: immunosuppressive chemotherapy; regular use of digoxin, amiodarone, verapamil or protease inhibitors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

160 participants in 2 patient groups

Colchicine group

Experimental group

Description:

Colchicine 0.5 mg tab 1x2 for 1 week then o.5mg tab. 1x1 for another week + the standard therapy

Treatment:

Drug: Colchicine 0.5 MG

Control group

No Intervention group

Description:

The patients in this group will receive only standard care which will include all or some of the following, according to the clinical condition of each patient: * Acetaminophen 500mg on need * Vitamin C 1000mg twice/ day * Zinc 75-125 mg/day * Vitamin D3 5000IU/day * Azithromycin 250mg/day for 5 days * Oxygen therapy/ C-Pap if needed * Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed * Mechanical ventilation, if needed