Phase 2
N=120
Colchicine Plus Phenolic Monoterpenes to Treat COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04392141 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Mortality Rate — 6; 1 Participants — p=0.0318
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Standard Treatment (Drug); Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Kermanshah University of Medical Sciences
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality Rate |
6; 1 | 0.0318 sig |
| SECONDARY SpO2 |
87.39; 90.94; 92.89; 93.49 | 0.0001 sig |
| SECONDARY Length of Hospitalization |
6.39; 4.17 | 0.0001 sig |
| SECONDARY Lymphocyte Count |
1.19; 1.31; 1.17; 1.74 | 0.80 |
| SECONDARY Serum Lactate Dehydrogenase |
664.98; 680.27; 691.04; 542.94 | 0.602 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04392141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.