Colchicine Plus Phenolic Monoterpenes to Treat COVID-19

COVID-19 Clinical Trial

Official title:

Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392141
• Other study ID #: 1399.062
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 1, 2020
• Est. completion date: November 1, 2020

Study information

• Verified date: April 2021
• Source: Kermanshah University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Standard Treatment
Standard Treatment for COVID-19 based on National Recommendations
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran	Kermanshah

Sponsors (1)

Lead Sponsor	Collaborator
Kermanshah University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (6)

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. — View Citation

Larsson S, Rønsted N. Reviewing Colchicaceae alkaloids - perspectives of evolution on medicinal chemistry. Curr Top Med Chem. 2014;14(2):274-89. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Rate	All cause of death in duration hospitalization	From admission to 14 days after being discharge.
Secondary	SpO2	Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry)	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.
Secondary	Length of Hospitalization	Day(s) each patient has spent in the hospital as an inpatient.	The duration of hospitalization for the patients (admission to discharge dates, approximately 4-14 days after admission). The patients who died were excluded.
Secondary	Lymphocyte Count	Lymphocyte count*1000/ mm^3	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.
Secondary	Serum Lactate Dehydrogenase	Serum lactate dehydrogenase: LDH (U/L)	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.