NCT04392141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

April 20, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

May 15, 2020

Results QC Date

November 25, 2020

Last Update Submit

April 16, 2021

Conditions

COVID-19

Keywords

COVID-19ColchicinePhenolic Monoterpenes

Outcome Measures

Primary Outcomes (1)

  • Mortality Rate

    All cause of death in duration hospitalization

    From admission to 14 days after being discharge.

Secondary Outcomes (4)

  • SpO2

    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.

  • Length of Hospitalization

    The duration of hospitalization for the patients (admission to discharge dates, approximately 4-14 days after admission). The patients who died were excluded.

  • Lymphocyte Count

    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

    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.

Study Arms (2)

Standard Treatment

EXPERIMENTAL

Patients diagnosed with COVID-19 which receive the standard treatment national guideline

Drug: Standard Treatment

Colchicine and Herbal Phenolic Monoterpene Fractions

EXPERIMENTAL

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

Interventions

Standard TreatmentDRUG

Standard Treatment for COVID-19 based on National Recommendations

Standard Treatment
Oral administration of Colchicine plus Herbal Phenolic Monoterpene FractionsDRUG

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

Colchicine and Herbal Phenolic Monoterpene Fractions

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Defined cases of COVID-19 based on laboratory and/or radiological and clinical manifestation

You may not qualify if:

  • Age \<10, Pregnancy, Sever kidney dysfunction, Previous history of allergy to Colchicine, not willing to sign informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran

Kermanshah, 083, Iran

Location

Related Publications (7)

  • 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.

    PMID: 25495322BACKGROUND

  • 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.

    PMID: 24359194BACKGROUND

  • 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.

    PMID: 29272515BACKGROUND

  • 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.

    PMID: 7543498BACKGROUND

  • 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.

    PMID: 26944958BACKGROUND

  • 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.

    PMID: 22193174BACKGROUND

  • 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.

    PMID: 34658014DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Prof. Ali Mostafaie
Organization
Kermanshah University of Medical Sciences
amostafaie@kums.ac.ir
+989188302044

Study Officials

  • Ali Mostafaie, PhD

    Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Immunology

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 18, 2020

Study Start

April 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

April 20, 2021

Results First Posted

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)