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Colchicine Plus Phenolic Monoterpenes to Treat COVID-19

NCT04392141 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-04-20

Study results available
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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.

Conditions

Interventions

DRUG

Standard Treatment

Standard Treatment for COVID-19 based on National Recommendations

DRUG

Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions

Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19.

Sponsors & Collaborators

  • Kermanshah University of Medical Sciences

    lead OTHER

Principal Investigators

  • Ali Mostafaie, PhD · Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2020-11-01
Completion
2020-11-01

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392141 on ClinicalTrials.gov