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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04392141
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Ali Mostafaie, PhD, Kermanshah University of Medical Sciences

Brief Summary:
In this study, defined cases of COVID-19 with mild, moderate or severe pneumonia will be treated with standard treatment regimens in combination with oral administration of Colchicine Plus Herbal phenolic monoterpene Fractions. Improvement in clinical, laboratory and radiological manifestations will be evaluated in treated patient compared to control group.

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)
Estimated Enrollment : 200 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
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arm Intervention/treatment
Experimental: standard Treatment Drug: Standard Treatment
Standard Treatment for COVID-19 based on National Recommendations

Experimental: 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: up to 30 days ]
    All cause of death


Secondary Outcome Measures :
  1. Change in patients clinical manifestation [ Time Frame: up to 30 days ]
    Mild, Moderate or Severe

  2. Length of hospitalization [ Time Frame: up to 30 days ]
    days

  3. C-reactive protein [ Time Frame: up to 30 days ]
  4. lymphocyte count [ Time Frame: up to 30 days ]
  5. serum lactate dehydrogenase [ Time Frame: up to 30 days ]
  6. serum Interleukin-6 [ Time Frame: up to 30 days ]
  7. erythrocyte sedimentation rate [ Time Frame: up to 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Contacts
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Contact: Ali Mostafaie, PhD +98 83 34279923 ali_mostafaie@yahoo.com
Contact: Yadollah Shakiba, MD, PhD yshakiba@gmail.com

Locations
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Iran, Islamic Republic of
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran Recruiting
Kermanshah, Iran, Islamic Republic of, 083
Contact: Ali Mostafaie, PhD    +98 83 34279923    ali_mostafaie@yahoo.com   
Principal Investigator: Ali Mostafaie, PhD         
Sub-Investigator: Siavash Vaziri, MD         
Sub-Investigator: Alireza Janbakhsh, MD         
Sub-Investigator: Yadollah Shakiba, MD, PhD         
Sub-Investigator: Farid Najafi, MD, PhD         
Sub-Investigator: Mohammad H Zamanian, MD         
Sub-Investigator: Ahmad Bagheri, MSc         
Sub-Investigator: Farhad Abdali, BSc         
Sub-Investigator: Kavyan Fatahpour, MSc         
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.
Publications of Results:
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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
Last Update Posted: May 18, 2020
Last Verified: May 2020
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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Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents