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

Study Overview
=================
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)

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

Conditions
-----------------
COVID-19 Pandemic

Intervention / Treatment
-----------------
* Drug: Colchicine 0.5 MG


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Patients refuse to enrol in the study Patients with hypersensitivity to colchicine 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 Pregnancy and breast feeding Medications: immunosuppressive chemotherapy; regular use of digoxin, amiodarone, verapamil or protease inhibitors.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine group<br>Colchicine 0.5 mg tab 1x2 for 1 week then o.5mg tab. 1x1 for another week + the standard therapy | Drug: Colchicine 0.5 MG<br>* 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).<br>* Other names: Colchicine;|
| No Intervention: Control group<br>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 | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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