Trial Outcomes & Findings for Colchicine Plus Phenolic Monoterpenes to Treat COVID-19 (NCT NCT04392141)
NCT ID: NCT04392141
Last Updated: 2021-04-20
Results Overview
All cause of death in duration hospitalization
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
120 participants
Primary outcome timeframe
From admission to 14 days after being discharge.
Results posted on
2021-04-20
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
60
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Treatment
n=60 Participants
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations
|
Colchicine and Herbal Phenolic Monoterpene Fractions
n=60 Participants
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.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.11 Year
STANDARD_DEVIATION 14.39 • n=60 Participants
|
52.99 Year
STANDARD_DEVIATION 15.88 • n=60 Participants
|
53.55 Year
STANDARD_DEVIATION 15.14 • n=120 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=60 Participants
|
28 Participants
n=60 Participants
|
55 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=60 Participants
|
32 Participants
n=60 Participants
|
65 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Iran
|
60 participants
n=60 Participants
|
60 participants
n=60 Participants
|
120 participants
n=120 Participants
|
|
Hypertension
|
12 Participants
n=60 Participants
|
20 Participants
n=60 Participants
|
32 Participants
n=120 Participants
|
|
Diabetic mellitus
|
3 Participants
n=60 Participants
|
6 Participants
n=60 Participants
|
9 Participants
n=120 Participants
|
|
Malignancy
|
2 Participants
n=60 Participants
|
5 Participants
n=60 Participants
|
7 Participants
n=120 Participants
|
|
Autoimmune diseases
|
3 Participants
n=60 Participants
|
6 Participants
n=60 Participants
|
9 Participants
n=120 Participants
|
|
Smoking/Substance abuse
|
2 Participants
n=60 Participants
|
8 Participants
n=60 Participants
|
10 Participants
n=120 Participants
|
|
Severe to critically ill COVID-19
|
48 Participants
n=60 Participants
|
52 Participants
n=60 Participants
|
100 Participants
n=120 Participants
|
|
lymphocytes count
|
1.19 cells*1000/mm^3
STANDARD_DEVIATION 0.45 • n=60 Participants
|
1.31 cells*1000/mm^3
STANDARD_DEVIATION 0.64 • n=60 Participants
|
1.26 cells*1000/mm^3
STANDARD_DEVIATION 0.56 • n=120 Participants
|
|
LDH
|
664.98 U/L
STANDARD_DEVIATION 295.84 • n=60 Participants
|
680.27 U/L
STANDARD_DEVIATION 471.44 • n=60 Participants
|
674.20 U/L
STANDARD_DEVIATION 401.78 • n=120 Participants
|
|
SpO2
|
87.39 Percentage of O2 saturation
STANDARD_DEVIATION 6.32 • n=60 Participants
|
90.94 Percentage of O2 saturation
STANDARD_DEVIATION 3.27 • n=60 Participants
|
89.53 Percentage of O2 saturation
STANDARD_DEVIATION 4.48 • n=120 Participants
|
PRIMARY outcome
Timeframe: From admission to 14 days after being discharge.All cause of death in duration hospitalization
Outcome measures
| Measure |
Standard Treatment
n=60 Participants
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations
|
Colchicine and Herbal Phenolic Monoterpene Fractions
n=60 Participants
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.
|
|---|---|---|
|
Mortality Rate
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Standard Treatment
n=60 Participants
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations
|
Colchicine and Herbal Phenolic Monoterpene Fractions
n=60 Participants
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.
|
|---|---|---|
|
SpO2
Admission
|
87.39 Percentage of oxygen saturation
Standard Deviation 6.32
|
90.94 Percentage of oxygen saturation
Standard Deviation 3.27
|
|
SpO2
Discharge
|
92.89 Percentage of oxygen saturation
Standard Deviation 1.76
|
93.49 Percentage of oxygen saturation
Standard Deviation 2.12
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard Treatment
n=54 Participants
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations
|
Colchicine and Herbal Phenolic Monoterpene Fractions
n=59 Participants
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.
|
|---|---|---|
|
Length of Hospitalization
|
6.39 Day
Standard Deviation 2.59
|
4.17 Day
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Standard Treatment
n=60 Participants
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations
|
Colchicine and Herbal Phenolic Monoterpene Fractions
n=60 Participants
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.
|
|---|---|---|
|
Lymphocyte Count
Admission
|
1.19 cells*1000/mm^3
Standard Deviation 0.45
|
1.31 cells*1000/mm^3
Standard Deviation 0.64
|
|
Lymphocyte Count
Discharge
|
1.17 cells*1000/mm^3
Standard Deviation 0.49
|
1.74 cells*1000/mm^3
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Standard Treatment
n=60 Participants
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations
|
Colchicine and Herbal Phenolic Monoterpene Fractions
n=60 Participants
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.
|
|---|---|---|
|
Serum Lactate Dehydrogenase
Admission
|
664.98 U/L
Standard Deviation 295.84
|
680.27 U/L
Standard Deviation 471.44
|
|
Serum Lactate Dehydrogenase
Discharge
|
691.04 U/L
Standard Deviation 299.09
|
542.94 U/L
Standard Deviation 225.67
|
Adverse Events
Standard Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 6 deaths
Colchicine and Herbal Phenolic Monoterpene Fractions
Serious events: 0 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Treatment
n=60 participants at risk
Patients diagnosed with COVID-19 which receive the standard treatment national guideline
Standard Treatment: Standard Treatment for COVID-19 based on National Recommendations
|
Colchicine and Herbal Phenolic Monoterpene Fractions
n=60 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea with or without vomiting
|
3.3%
2/60 • Number of events 2 • 1 month
|
3.3%
2/60 • Number of events 2 • 1 month
|
|
Nervous system disorders
Restlessness
|
0.00%
0/60 • 1 month
|
1.7%
1/60 • Number of events 1 • 1 month
|
|
Cardiac disorders
Palpitation
|
0.00%
0/60 • 1 month
|
1.7%
1/60 • Number of events 1 • 1 month
|
Additional Information
Prof. Ali Mostafaie
Kermanshah University of Medical Sciences
Phone: +989188302044
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place