Colchicine Plus Phenolic Monoterpenes to Treat COVID-19

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: Standard Treatment; Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions

• Registration Number: NCT04392141
• Lead Sponsor: Kermanshah University of Medical Sciences

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

Not available

Study Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-01
• Results First Submitted: 2020-11-25
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-16
• Last Update Submitted: 2021-04-16
• Results First Posted: 2021-04-20
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Defined cases of COVID-19 based on laboratory and/or radiological and clinical manifestation

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Exclusion Criteria

• Age <10, Pregnancy, Sever kidney dysfunction, Previous history of allergy to Colchicine, not willing to sign informed consent form

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Treatment	Standard Treatment	Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Colchicine and Herbal Phenolic Monoterpene Fractions	Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions	Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions

Primary Outcome Measures

Name	Time	Method
Mortality Rate	From admission to 14 days after being discharge.	All cause of death in duration hospitalization

Secondary Outcome Measures

Name	Time	Method
SpO2	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.	Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry)
Length of Hospitalization	The duration of hospitalization for the patients (admission to discharge dates, approximately 4-14 days after admission). The patients who died were excluded.	Day(s) each patient has spent in the hospital as an inpatient.
Lymphocyte Count	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.	Lymphocyte count\*1000/ mm\^3
Serum Lactate Dehydrogenase	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: LDH (U/L)

Trial Locations

Locations (1)

Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran; 🇮🇷 Kermanshah, Iran, Islamic Republic of