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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Treatment | Experimental | Patients diagnosed with COVID-19 which receive the standard treatment national guideline |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Treatment | Drug | Standard Treatment for COVID-19 based on National Recommendations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | All cause of death in duration hospitalization | From admission to 14 days after being discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Length of Hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Mostafaie, PhD | Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran | Kermanshah | 083 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25495322 | Background | 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. | |
| 24359194 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Treatment | Patients diagnosed with COVID-19 which receive the standard treatment national guideline Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations |
| FG001 | Colchicine and Herbal Phenolic Monoterpene Fractions | Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Treatment | Patients diagnosed with COVID-19 which receive the standard treatment national guideline Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations |
| BG001 | Colchicine and Herbal Phenolic Monoterpene Fractions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality Rate | All cause of death in duration hospitalization | Posted | Count of Participants | Participants | From admission to 14 days after being discharge. |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Treatment | Patients diagnosed with COVID-19 which receive the standard treatment national guideline Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea with or without vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Ali Mostafaie | Kermanshah University of Medical Sciences | +989188302044 | amostafaie@kums.ac.ir |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 20, 2021 | Jan 21, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2021 | Apr 16, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions | Drug | Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19. |
|
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. |
| 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. |
| 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. |
| 29272515 | Background | 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. |
| 7543498 | Background | 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. |
| 26944958 | Background | 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. |
| 22193174 | Background | 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. |
| 34658014 | Derived | 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. |
Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions 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. |
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetic mellitus | Count of Participants | Participants |
|
| Malignancy | Count of Participants | Participants |
|
| Autoimmune diseases | Count of Participants | Participants |
|
| Smoking/Substance abuse | Count of Participants | Participants |
|
| Severe to critically ill COVID-19 | Moderate Illness: Individuals who show evidence of lower respiratory disease during clinical assessment or imaging and who have saturation of oxygen (SpO2) ≥94%. Severe Illness: Individuals who have SpO2 <94%, respiratory frequency >30 breaths/min, or lung infiltrates >50%. Critical Illness: Individuals who have respiratory failure, septic shock, and/or multiple organ dysfunction. The definition of severe to critically ill COVID-19 patient is according to the National Health Institute (NIH). | Count of Participants | Participants |
|
| lymphocytes count | Mean | Standard Deviation | cells*1000/mm^3 |
|
| LDH | Mean | Standard Deviation | U/L |
|
| SpO2 | Mean | Standard Deviation | Percentage of O2 saturation |
|
|
|
|
| Secondary | SpO2 | Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry) | Posted | Mean | Standard Deviation | Percentage of oxygen saturation | 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. | Posted | Mean | Standard Deviation | Day | 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 | Posted | Mean | Standard Deviation | cells*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) | Posted | Mean | Standard Deviation | 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. |
|
|
|
|
| 6 |
| 60 |
| 0 |
| 60 |
| 2 |
| 60 |
| EG001 | Colchicine and Herbal Phenolic Monoterpene Fractions | Patients diagnosed with COVID-19 which receive the standard treatment national guideline plus Colchicine and Herbal Phenolic Monoterpene Fractions 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. | 1 | 60 | 0 | 60 | 4 | 60 |
| Restlessness | Nervous system disorders | Systematic Assessment |
|
| Palpitation | Cardiac disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Statistical comparison of SpO2 % between admission and discharge times in the Colchicine and Herbal Phenolic Monoterpene Fractions treatment |
| t-test, 2 sided |
Paired T-test |
| 0.0001 |
| Mean Difference (Final Values) |
| -2.55 |
| 2-Sided |
| 95 |
| -3.28 |
| -1.81 |
| Equivalence |
equivalence of SpO2 percentage between admission and discharge phases |
Statistical comparison of lymphocytes count between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment |
| t-test, 2 sided |
Paired T-test |
| 0.0001 |
| Mean Difference (Final Values) |
| -0.43 |
| 2-Sided |
| 95 |
| -0.63 |
| -0.23 |
| Equivalence |
equivalence of mean of lymphocytes count between admission and discharge phases |
Statistical comparison of LDH between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatment |
| t-test, 2 sided |
Paired T-test |
| 0.006 |
| Mean Difference (Final Values) |
| 137.33 |
| 2-Sided |
| 95 |
| 38.19 |
| 236.46 |
| Equivalence |
equivalence of mean of LDH between admission and discharge phases |