Colchicine Plus Phenolic Monoterpenes to Treat COVID-19

Kermanshah University of Medical Sciences

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Drug: Standard Treatment; Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions

Study type: Interventional

Funder types: Other

Identifiers

NCT04392141

1399.062

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Standard Treatment

Experimental group

Description:

Patients diagnosed with COVID-19 which receive the standard treatment national guideline

Treatment:

Drug: Standard Treatment

Colchicine and Herbal Phenolic Monoterpene Fractions

Experimental group

Description:

Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions

Treatment:

Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions