COVID-19
Conditions
Keywords
COVID-19, Colchicine, Phenolic Monoterpenes
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.
Interventions
DRUGStandard Treatment
Standard Treatment for COVID-19 based on National Recommendations
DRUGOral 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.
Sponsors
Kermanshah University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality Rate | From admission to 14 days after being discharge. | All cause of death in duration hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry) |
| 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. | Day(s) each patient has spent in the hospital as an inpatient. |
| 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. | Lymphocyte count\*1000/ mm\^3 |
| 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. | Serum lactate dehydrogenase: LDH (U/L) |
Countries
Iran
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| 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. | 60 |
| Total | 120 |
Baseline characteristics
| Characteristic | Colchicine and Herbal Phenolic Monoterpene Fractions | Total | Standard Treatment |
|---|---|---|---|
| Age, Continuous | 52.99 Year STANDARD_DEVIATION 15.88 | 53.55 Year STANDARD_DEVIATION 15.14 | 54.11 Year STANDARD_DEVIATION 14.39 |
| Autoimmune diseases | 6 Participants | 9 Participants | 3 Participants |
| Diabetic mellitus | 6 Participants | 9 Participants | 3 Participants |
| Hypertension | 20 Participants | 32 Participants | 12 Participants |
| LDH | 680.27 U/L STANDARD_DEVIATION 471.44 | 674.20 U/L STANDARD_DEVIATION 401.78 | 664.98 U/L STANDARD_DEVIATION 295.84 |
| lymphocytes count | 1.31 cells*1000/mm^3 STANDARD_DEVIATION 0.64 | 1.26 cells*1000/mm^3 STANDARD_DEVIATION 0.56 | 1.19 cells*1000/mm^3 STANDARD_DEVIATION 0.45 |
| Malignancy | 5 Participants | 7 Participants | 2 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Iran | 60 participants | 120 participants | 60 participants |
| Severe to critically ill COVID-19 | 52 Participants | 100 Participants | 48 Participants |
| Sex: Female, Male Female | 28 Participants | 55 Participants | 27 Participants |
| Sex: Female, Male Male | 32 Participants | 65 Participants | 33 Participants |
| Smoking/Substance abuse | 8 Participants | 10 Participants | 2 Participants |
| SpO2 | 90.94 Percentage of O2 saturation STANDARD_DEVIATION 3.27 | 89.53 Percentage of O2 saturation STANDARD_DEVIATION 4.48 | 87.39 Percentage of O2 saturation STANDARD_DEVIATION 6.32 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 60 | 1 / 60 |
| other Total, other adverse events | 2 / 60 | 4 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Mortality Rate
All cause of death in duration hospitalization
Time frame: From admission to 14 days after being discharge.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment | Mortality Rate | 6 Participants |
| Colchicine and Herbal Phenolic Monoterpene Fractions | Mortality Rate | 1 Participants |
p-value: 0.031895% CI: [1.16, 83.89]Fisher Exact
Secondary
Length of Hospitalization
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Length of Hospitalization | 6.39 Day | Standard Deviation 2.59 |
| Colchicine and Herbal Phenolic Monoterpene Fractions | Length of Hospitalization | 4.17 Day | Standard Deviation 1.34 |
p-value: 0.000195% CI: [1.63, 2.8]Wilcoxon (Mann-Whitney)
Secondary
Lymphocyte Count
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Treatment | Lymphocyte Count | Admission | 1.19 cells*1000/mm^3 | Standard Deviation 0.45 |
| Standard Treatment | Lymphocyte Count | Discharge | 1.17 cells*1000/mm^3 | Standard Deviation 0.49 |
| Colchicine and Herbal Phenolic Monoterpene Fractions | Lymphocyte Count | Admission | 1.31 cells*1000/mm^3 | Standard Deviation 0.64 |
| Colchicine and Herbal Phenolic Monoterpene Fractions | Lymphocyte Count | Discharge | 1.74 cells*1000/mm^3 | Standard Deviation 0.83 |
Comparison: Statistical comparison of lymphocytes count between admission and discharge times in standard treatmentp-value: 0.895% CI: [-0.136, 0.176]t-test, 2 sided
Comparison: Statistical comparison of lymphocytes count between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatmentp-value: 0.000195% CI: [-0.63, -0.23]t-test, 2 sided
Secondary
Serum Lactate Dehydrogenase
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Treatment | Serum Lactate Dehydrogenase | Admission | 664.98 U/L | Standard Deviation 295.84 |
| Standard Treatment | Serum Lactate Dehydrogenase | Discharge | 691.04 U/L | Standard Deviation 299.09 |
| Colchicine and Herbal Phenolic Monoterpene Fractions | Serum Lactate Dehydrogenase | Admission | 680.27 U/L | Standard Deviation 471.44 |
| Colchicine and Herbal Phenolic Monoterpene Fractions | Serum Lactate Dehydrogenase | Discharge | 542.94 U/L | Standard Deviation 225.67 |
Comparison: Statistical comparison of LDH between admission and discharge times in standard treatmentp-value: 0.60295% CI: [-124.76, 72.64]t-test, 2 sided
Comparison: Statistical comparison of LDH between admission and discharge times in Colchicine and Herbal Phenolic Monoterpene Fractions treatmentp-value: 0.00695% CI: [38.19, 236.46]t-test, 2 sided
Secondary
SpO2
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Treatment | SpO2 | Admission | 87.39 Percentage of oxygen saturation | Standard Deviation 6.32 |
| Standard Treatment | SpO2 | Discharge | 92.89 Percentage of oxygen saturation | Standard Deviation 1.76 |
| Colchicine and Herbal Phenolic Monoterpene Fractions | SpO2 | Admission | 90.94 Percentage of oxygen saturation | Standard Deviation 3.27 |
| Colchicine and Herbal Phenolic Monoterpene Fractions | SpO2 | Discharge | 93.49 Percentage of oxygen saturation | Standard Deviation 2.12 |
Comparison: Statistical comparison of SpO2 (%) between admission and discharge times in standard treatment groupp-value: 0.000195% CI: [-7.03, -3.96]t-test, 2 sided
Comparison: Statistical comparison of SpO2 % between admission and discharge times in the Colchicine and Herbal Phenolic Monoterpene Fractions treatmentp-value: 0.000195% CI: [-3.28, -1.81]t-test, 2 sided