Evaluation of colchicine tablet efficacy as an adjuvant treatment for patients with mild to moderate COVID-19 in Qaem Hospital, Mashhad: A triple-blind randomized placebo controlled clinical trial

Evaluation of the colchicine efficacy as a supplement for treatment of mild to moderate COVID-19

This is a randomized triple-blind, parallel group clinical trial on 40 patients with mild to moderate covid-19 (20 patients in treatment group and 20 patients in placebo group).

This study will perform on 40 patients with clinical or laboratory diagnosis of mild to moderate covid-19 who refer to Quem Hospital, Mashhad, Iran. They whether will received one colchicine 1mg tablet daily for 2 weeks in treatment group or one placebo tablet in placebo group.

Inclusion criteria: Laboratory or radiologic or clinical diagnosis of mild to moderate COVID-19, age between 18-85y, sign of the written consent Exclusion criteria: pregnancy or lactation, history of allergy to colchicine, concomitant use of protease inhibitors, potent CYP3A4 or pgp inhibitors or inducers, adverse drug reaction occurrence, past medical diseases (e.g. kidney, hepatic, heart failure, active GI ulcer, neuromuscular disease, chronic diarrhea, malabsorption)

Treatment group: one colchicine tablet daily for 2 weeks, Control group: one placebo tablet daily for two weeks

Primary endpoints of the study are rates of treatment response and adverse drug reactions. Secondary endpoints are duration of hospitalization and patients' clinical outcomes.

With the help of a randomization list provided by randomization.com site, patients will receive code 1 or 2 and will be included in placebo or medication group.

The colchicine and placebo tablets will be packaged in identical-looking bottle and delivered to the clinician. Patients who meet the inclusion criteria are selected by clinician to be included in the study, randomly assigned to a drug or placebo group and given a bottle with A or B mark. Patients will be evaluated in the course of treatment by the physician and the pharmacy student. Data collection and analysis are performed by the pharmacy student and the clinical pharmacist. All of them will be unaware that A or B is on medication or placebo until the end of the study and data analysis.

The findings will be published in an article. Study protocol and statistical analysis will be used for article publication.

One year after the end of the study it will be published and available in databases.

If the funding sponsor allowed, the findings will be available for researchers, clinicians, and scientific centers.

The other researchers can use our findings in their review articles and meta analysis.

For this purpose, you can contact with Sepideh Elyasi, at Clinical Pharmacy Department, School of Pharmacy, Vakil Abad Aven., Mashhad, Iran. Email: elyasis@mums.ac.ir

After receiving the query, dependent on the requested data, the scientific responsible person of the study will response to the query in coordinate with the sponsor within 2 weeks