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

Phase 1

Completed

• Conditions: COVID-19 Pandemic
• Interventions: Drug: Colchicine 0.5 MG

• Registration Number: NCT05151614
• Lead Sponsor: University of Baghdad

Brief Summary

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

Detailed 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)

Study Timeline

• Study Start: 2021-04-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2021-11
• Study First Submitted: 2021-11-27
• Study First Submitted QC: 2021-11-27
• Last Update Submitted: 2021-11-27
• Study First Posted: 2021-12-09
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine group	Colchicine 0.5 MG	Colchicine 0.5 mg tab 1x2 for 1 week then o.5mg tab. 1x1 for another week + the standard therapy

Primary Outcome Measures

Name	Time	Method
- To assess the percentage of cure of the patients	up to 14 days	evauated by normalization of clinical evaluation, laboratory investigations, and imaging
- Study the time to recovery	up to 14 days	Evaluated by stay days in hospital

Secondary Outcome Measures

Name	Time	Method
- to assess side effects seen during the trial	up to 14 days	assessed according clinical evaluation and the appropriate laboratory investigation

Trial Locations

Locations (1)

University of Baghdad; 🇮🇶 Baghdad, Iraq