Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19
Phase: PHASE1
Conditions: COVID-19
Sponsor: Kermanshah University of Medical Sciences

Colchicine Plus Phenolic Monoterpenes to Treat COVID-19 (NCT04392141), 01/20/2021 
Objectives  
This study aimed to evaluate clinical and laboratory parameters in two groups of inpatients 
diagnosed with COVID-19. The control group received conventional therapy and the study group 
treated with conventional therapy as well as the intervention treatment. Different variables such as 
mortality ratio, hospitalization duration, intensive care unit (ICU) admission, O2 saturation, and 
different laboratory data (such a lymphocyte count) were assessed between the groups.  
Study design and method  
This randomized controlled parallel clinical trial was performed in a COVID-19 special hospital 
in Kermanshah, Iran. Inpatients individuals older than 10 years old with a confirmed diagnosis of 
COVID-19 according to the SARS-CoV-2 real-time polymerase chain reaction (RT-PCR) and/or 
lungs computed tomography (CT) scan would be evaluated for further assessments. The exclusion 
criteria were defined as pregnancy, and chronic liver disease. Patients who met both the inclusion 
and exclusion criteria, allocated into the two study groups through simple randomization method. 
The variables mentioned in the objectives were assessed between the two groups. Also, the patients 
followed for 2 weeks after discharge. Fever was defined according to the guidelines by the Centers 
for Disease Control and Prevention (CDC) and the Iranian Ministry of Health and Medical 
Education as body temperature of >38°C and 37.8°C respectively. Acute respiratory distress 
syndrome defined according to the Berlin definition. The severe COVID-19 was defined according 
to the National Institute of Health (NIH) definition.  
Ethics  
The aims and methods of this study clearly explained for patients or their legal guardians (in case 
of being less than 18-year-old) according to their level of knowledge and they were asked to sign  

Colchicine Plus Phenolic Monoterpenes to Treat COVID-19 (NCT04392141), 01/20/2021 
a consent form freely following the explanations. This study was approved by the Medical Ethics 
Committee of Kermanshah University of Medical Sciences. Also, it has been recorded in the 
Iranian 
Registry 
of 
Clinical 
Trial 
(IRCT20150623022884N3) 
and 
clinicaltrials.gov 
(NCT04392141). All the authors adhered to the Helsinki 1964 Declaration and its further revisions.