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

COVID-19 Pandemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05151614
• Other study ID #: PRO21230003
• Status: Completed
• Phase: Phase 1
• Start date: April 1, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2021
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19
• COVID-19 Pandemic
• Virus Diseases

Intervention

Drug:
• Colchicine 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).

Locations

Country	Name	City	State
Iraq	University of Baghdad	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- To assess the percentage of cure of the patients	evauated by normalization of clinical evaluation, laboratory investigations, and imaging	up to 14 days
Primary	- Study the time to recovery	Evaluated by stay days in hospital	up to 14 days
Secondary	- to assess side effects seen during the trial	assessed according clinical evaluation and the appropriate laboratory investigation	up to 14 days