COVID-19Phase 1/2NCT04392141
Colchicine Plus Phenolic Monoterpenes to Treat COVID-19
A Phase 1/2 study testing Standard Treatment and Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions in people with COVID-19, run by Kermanshah University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Standard Treatment and Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- 1 Apr 2020to 1 Nov 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Defined cases of COVID-19 based on laboratory and/or radiological and clinical manifestation
Who cannot join
- Age <10, Pregnancy, Sever kidney dysfunction, Previous history of allergy to Colchicine, not willing to sign informed consent form
Trial locations and contacts
1 site in 1 country.
Iran1 site
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Kermanshah, 083
About this study
Official title: Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19
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.
- Conditions
- COVID-19
- Being tested
- Standard Treatment, Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions
- Keywords
- COVID-19, Colchicine, Phenolic Monoterpenes
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Treatment for COVID-19 based on National Recommendations
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment | Experimental | Patients diagnosed with COVID-19 which receive the standard treatment national guideline Receives: 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 Receives: Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rate
All cause of death in duration hospitalization
Measured: From admission to 14 days after being discharge.
Secondary outcomes (4)
SpO2
Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry)
Measured: 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
Day(s) each patient has spent in the hospital as an inpatient.
Measured: 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
Lymphocyte count*1000/ mm^3
Measured: 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
Serum lactate dehydrogenase: LDH (U/L)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Apr 2020
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kermanshah University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ali Mostafaie, PhD, Kermanshah University of Medical Sciences
- Investigators
- Ali Mostafaie, PhD, Principal investigator, Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392141
- Sponsor's protocol ID
- 1399.062
- Status last verified
- Apr 2021
- First submitted
- 15 May 2020
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25495322Larsson 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.
PubMed 24359194Slobodnick 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.
PubMed 29272515Cronstein 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.
PubMed 7543498Umar 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.
PubMed 26944958Wu 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.
PubMed 22193174Mikolajewska 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.
PubMed 34658014
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19
- ClinicalTrials.gov ID
- NCT04392141
- Acronym / sponsor ID
- 1399.062
- Conditions
- COVID-19
- Keywords
- COVID-19, Colchicine, Phenolic Monoterpenes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kermanshah University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | Experimental | Drug: Standard TreatmentPatients diagnosed with COVID-19 which receive the standard treatment national guideline |
| Colchicine and Herbal Phenolic Monoterpene Fractions | Experimental | Drug: Oral administration of Colchicine plus Herbal Phenolic Monoterpene FractionsPatients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Defined cases of COVID-19 based on laboratory and/or radiological and clinical manifestation
Key exclusion criteria (1 listed)
- Age <10, Pregnancy, Sever kidney dysfunction, Previous history of allergy to Colchicine, not willing to sign informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard TreatmentStandard Treatment for COVID-19 based on National Recommendations | Drug | Standard Treatment |
| Oral administration of Colchicine plus Herbal Phenolic Monoterpene FractionsColchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19. | Drug | Colchicine and Herbal Phenolic Monoterpene Fractions |
Primary outcome
Mortality Rate
Time frame: From admission to 14 days after being discharge.
All cause of death in duration hospitalization
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25495322Nerlekar 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.
- Background: PubMed 24359194Larsson 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.
- Background: PubMed 29272515Slobodnick 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.
- Background: PubMed 7543498Cronstein 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.
- Background: PubMed 26944958Umar 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.
- Background: PubMed 22193174Wu 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.
- Derived from this study: PubMed 34658014Mikolajewska 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Mostafaie, PhD principal investigator
Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Standard Treatment and Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions in people with COVID-19, run by Kermanshah University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Rate (time frame: From admission to 14 days after being discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392141, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.