Clinical trial NCT04392141: Colchicine Plus Phenolic Monoterpenes to Treat COVID-19
Official title: Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: COVID-19
Colchicine
Phenolic Monoterpenes
Lead sponsor: Kermanshah University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mortality Rate
timeFrame: From admission to 14 days after being discharge.
Secondary outcomes:
measure: SpO2
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.
measure: Length of Hospitalization
timeFrame: The duration of hospitalization for the patients (admission to discharge dates, approximately 4-14 days after admission). The patients who died were excluded.
measure: Lymphocyte Count
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.
measure: Serum Lactate Dehydrogenase
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.
Other outcomes:
Locations:
city: Kermanshah
country: Iran, Islamic Republic of
facility: Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran
Study officials:
affiliation: Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.
name: Ali Mostafaie, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.