Colchicine Plus Phenolic Monoterpenes to Treat COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Standard Treatment
* Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Defined cases of COVID-19 based on laboratory and/or radiological and clinical manifestation Exclusion Criteria: Age <10, Pregnancy, Sever kidney dysfunction, Previous history of allergy to Colchicine, not willing to sign informed consent form

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard Treatment<br>Patients diagnosed with COVID-19 which receive the standard treatment national guideline | Drug: Standard Treatment<br>* Standard Treatment for COVID-19 based on National Recommendations<br>|
| Experimental: Colchicine and Herbal Phenolic Monoterpene Fractions<br>Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions | Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions<br>* Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | All cause of death in duration hospitalization | From admission to 14 days after being discharge. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 | Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry) | Admission to discharge dates (approximately 4-14 days after admission). Discharge variables considered as the last available data before their death for the expired patients. | 
| Length of Hospitalization | Day(s) each patient has spent in the hospital as an inpatient. | The duration of hospitalization for the patients (admission to discharge dates, approximately 4-14 days after admission). The patients who died were excluded. | 
| Lymphocyte Count | Lymphocyte count*1000/ mm^3 | Admission to discharge dates (approximately 4-14 days after admission). Discharge variables considered as the last available data before their death for the expired patients. | 
| Serum Lactate Dehydrogenase | Serum lactate dehydrogenase: LDH (U/L) | Admission to discharge dates (approximately 4-14 days after admission). Discharge variables considered as the last available data before their death for the expired patients. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Colchicine, Phenolic Monoterpenes