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Colchicine Plus Phenolic Monoterpenes to Treat COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392141
Recruitment Status : Completed
First Posted : May 18, 2020
Results First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Ali Mostafaie, PhD, 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Standard Treatment Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19
Actual Study Start Date : April 1, 2020
Actual Primary Completion Date : November 1, 2020
Actual Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: Standard Treatment
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Drug: Standard Treatment
Standard Treatment for COVID-19 based on National Recommendations

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




Primary Outcome Measures :
  1. Mortality Rate [ Time Frame: From admission to 14 days after being discharge. ]
    All cause of death in duration hospitalization


Secondary Outcome Measures :
  1. SpO2 [ Time Frame: 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)

  2. Length of Hospitalization [ Time Frame: 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.

  3. Lymphocyte Count [ Time Frame: 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

  4. Serum Lactate Dehydrogenase [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04392141


Locations
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Iran, Islamic Republic of
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Kermanshah, Iran, Islamic Republic of, 083
Sponsors and Collaborators
Kermanshah University of Medical Sciences
Investigators
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Principal Investigator: Ali Mostafaie, PhD Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.
  Study Documents (Full-Text)

Documents provided by Dr. Ali Mostafaie, PhD, Kermanshah University of Medical Sciences:
Study Protocol  [PDF] January 20, 2021
Statistical Analysis Plan  [PDF] January 20, 2021

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Ali Mostafaie, PhD, Professor of Immunology, Kermanshah University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04392141    
Other Study ID Numbers: 1399.062
First Posted: May 18, 2020    Key Record Dates
Results First Posted: April 20, 2021
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Ali Mostafaie, PhD, Kermanshah University of Medical Sciences:
COVID-19
Colchicine
Phenolic Monoterpenes
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents