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OpenTrials
Completed

NCT Number: NCT04392141

Colchicine Plus Phenolic Monoterpenes to Treat COVID-19

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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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical Biology Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran

Kermanshah, 083, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

standard treatment

Drug

Standard Treatment for COVID-19 based on National Recommendations

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.

Primary outcomes

  1. Mortality Rate

    Time frame: From admission to 14 days after being discharge.

    All cause of death in duration hospitalization

Secondary outcomes

  1. SpO2

    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.

    Change in patients' oxygen saturation levels assessed by non-invasive method (pulse oximetry)

  2. Length of Hospitalization

    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.

    Day(s) each patient has spent in the hospital as an inpatient.

  3. Lymphocyte Count

    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.

    Lymphocyte count*1000/ mm^3

  4. Serum Lactate Dehydrogenase

    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.

    Serum lactate dehydrogenase: LDH (U/L)

Sponsors and collaborators

Lead sponsor

Kermanshah University of Medical Sciences

Other

Registry information

Official study title

Application of Colchicine Plus Herbal Phenolic Monoterpene Fractions to Treat COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 18, 2020
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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