Clinical trial NCT04392141
Conditions: COVID-19
Keywords: COVID-19 Colchicine Phenolic Monoterpenes
Sponsor: Kermanshah University of Medical Sciences
Start date: 2020-04-01; Completion date: 2020-11-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this randomized controlled clinical trial, defined cases of COVID-19 with mild, moderate, or severe pneumonia (according to the NIH guideline) were treated with conventional treatment regimens (controls) as well as in combination with oral administration of colchicine plus herbal phenolic monoterpene fractions (intervention arm). After randomization, each group received the mentioned treatments and were evaluated for different variables including mortality, hospitalization duration, intensive care unit (ICU) administration ratios as well as laboratory variables such as leukocytes and lymphocytes count. The follow-up period considered as 2 weeks after discharge. The mentioned variables were assessed as before and after receiving the treatment in each group as well as intergroup analysis for comparing both baseline and final values.

Detailed description:

Arms: arm 1: Patients diagnosed with COVID-19 which receive the standard treatment national guideline arm 2: Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions
Interventions: intervention 1: Standard Treatment intervention 2: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions
Intervention descriptions: intervention 1: Standard Treatment for COVID-19 based on National Recommendations intervention 2: Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19.

Protocol documents:
Prot_000.pdf: 
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. 

SAP_001.pdf: 
Colchicine plus Phenolic Monoterpenes to Treat COVID-19 (NCT04392141), 01/20/2021 
After collection of data, all continuous variables were presented as the mean ± standard deviation. 
Categorical variables are presented as N (%). The Kolmogorov–Smirnov test was performed for checking the 
normality assumption. Moreover, the equality of variance between both groups was tested by Levene’s test. 
After checking the parametric assumptions, Student's t-test (parametric) or the Mann Whitney test (non-
parametric) was used to test for statistical differences (two-tailed) between two independent groups. Also 
paired t-test (parametric) or the Wilcoxon signed-rank test (non-parametric) was used to test for statistical 
differences between two-time points in each of intervention groups. Two-sided Chi square/Fisher’s exact 
tests were used to assess the associations between intervention groups and the categorical variables. After 
analyzing the baseline data, using the intention-to-treat (ITT) test, the multiple imputations were conducted 
by an expectation–maximization (EM) algorithm for making an unbiased comparison between intervention 
groups in handling missing data. The P-values were not adjusted for multiple testing. All statistical analysis 
was analyzed using SPSS software (Versions 25). Statistical significance was considered at p<0.05