Colchicine Plus Phenolic Monoterpenes to Treat COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Standard Treatment
Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Colchicine, Phenolic Monoterpenes
Eligibility 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
Sites / Locations
- Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Standard Treatment
Colchicine and Herbal Phenolic Monoterpene Fractions
Arm Description
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions
Outcomes
Primary Outcome Measures
Mortality Rate
All cause of death in duration hospitalization
Secondary Outcome Measures
SpO2
Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry)
Length of Hospitalization
Day(s) each patient has spent in the hospital as an inpatient.
Lymphocyte Count
Lymphocyte count*1000/ mm^3
Serum Lactate Dehydrogenase
Serum lactate dehydrogenase: LDH (U/L)
Full Information
NCT ID
NCT04392141
First Posted
May 15, 2020
Last Updated
April 16, 2021
Sponsor
Kermanshah University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04392141
Brief Title
Colchicine Plus Phenolic Monoterpenes to Treat COVID-19
Official Title
Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kermanshah University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Colchicine, Phenolic Monoterpenes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Treatment
Arm Type
Experimental
Arm Description
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Arm Title
Colchicine and Herbal Phenolic Monoterpene Fractions
Arm Type
Experimental
Arm Description
Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions
Intervention Type
Drug
Intervention Name(s)
Standard Treatment
Intervention Description
Standard Treatment for COVID-19 based on National Recommendations
Intervention Type
Drug
Intervention Name(s)
Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions
Intervention Description
Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19.
Primary Outcome Measure Information:
Title
Mortality Rate
Description
All cause of death in duration hospitalization
Time Frame
From admission to 14 days after being discharge.
Secondary Outcome Measure Information:
Title
SpO2
Description
Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry)
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.
Title
Length of Hospitalization
Description
Day(s) each patient has spent in the hospital as an inpatient.
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.
Title
Lymphocyte Count
Description
Lymphocyte count*1000/ mm^3
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.
Title
Serum Lactate Dehydrogenase
Description
Serum lactate dehydrogenase: LDH (U/L)
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Mostafaie, PhD
Organizational Affiliation
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
ZIP/Postal Code
083
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25495322
Citation
Nerlekar N, Beale A, Harper RW. Colchicine--a short history of an ancient drug. Med J Aust. 2014 Dec 11;201(11):687-8. doi: 10.5694/mja14.00846. No abstract available.
Results Reference
background
PubMed Identifier
24359194
Citation
Larsson S, Ronsted N. Reviewing Colchicaceae alkaloids - perspectives of evolution on medicinal chemistry. Curr Top Med Chem. 2014;14(2):274-89. doi: 10.2174/1568026613666131216110417.
Results Reference
background
PubMed Identifier
29272515
Citation
Slobodnick A, Shah B, Krasnokutsky S, Pillinger MH. Update on colchicine, 2017. Rheumatology (Oxford). 2018 Jan 1;57(suppl_1):i4-i11. doi: 10.1093/rheumatology/kex453.
Results Reference
background
PubMed Identifier
7543498
Citation
Cronstein BN, Molad Y, Reibman J, Balakhane E, Levin RI, Weissmann G. Colchicine alters the quantitative and qualitative display of selectins on endothelial cells and neutrophils. J Clin Invest. 1995 Aug;96(2):994-1002. doi: 10.1172/JCI118147.
Results Reference
background
PubMed Identifier
26944958
Citation
Umar S, Shah MAA, Munir MT, Yaqoob M, Fiaz M, Anjum S, Kaboudi K, Bouzouaia M, Younus M, Nisa Q, Iqbal M, Umar W. RETRACTED: Synergistic effects of thymoquinone and curcumin on immune response and anti-viral activity against avian influenza virus (H9N2) in turkeys. Poult Sci. 2016 Jul 1;95(7):1513-1520. doi: 10.3382/ps/pew069. Epub 2016 Mar 4.
Results Reference
background
PubMed Identifier
22193174
Citation
Wu QF, Wang W, Dai XY, Wang ZY, Shen ZH, Ying HZ, Yu CH. Chemical compositions and anti-influenza activities of essential oils from Mosla dianthera. J Ethnopharmacol. 2012 Jan 31;139(2):668-71. doi: 10.1016/j.jep.2011.11.056. Epub 2011 Dec 16.
Results Reference
background
PubMed Identifier
34658014
Citation
Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
Results Reference
derived
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Colchicine Plus Phenolic Monoterpenes to Treat COVID-19
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