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

Adjuvant Use Of Colchicine With The Standard Therapy In Moderate And Severe Corona Virus Disease-19 Infection: Randomized Controlled Clinical Trial

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05151614

Enrollment

160

Registered

2021-12-09

Start date

2021-04-01

Completion date

2021-10-30

Last updated

2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pandemic

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)

Interventions

DRUGColchicine 0.5 MG

Colchicine 0.5 mg tab 1x2 for 1 week then o.5mg tab. 1x1 for another week + the standard therapy ( total duration of colchicine 14 days).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
- 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

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

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026