Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients

Covid19 Clinical Trial

Official title:

Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04849637
• Other study ID #: UPMREB 2020-306-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 22, 2020
• Est. completion date: April 9, 2022

Study information

• Verified date: March 2022
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a research that will investigate the safety and efficacy of virgin coconut oil (VCO) as an adjunctive therapy for Coronavirus Disease 2019 (COVID-19)

Description:

This study will be a randomized controlled trial among hospitalized COVID-19 patients, aged 18 years old and above, admitted at the Philippine General hospital. Patients will be grouped into the following:

1. Group receiving standard of care

2. Group receiving standard of care plus virgin coconut oil (15ml, 3x/day for 2 weeks) as adjunctive therapy.

Patients will be observed as regards to primary outcomes such as recovery/resolution of symptoms and duration of hospital stay

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 74
• Est. completion date: April 9, 2022
• Est. primary completion date: April 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• symptomatic and asymptomatic COVID-19 hospitalized patients

• has laboratory-confirmed illness during the time of recruitment

• able to take food and medicines enterally

Exclusion Criteria:

• uncontrolled or newly diagnosed diabetes mellitus

• with chronic heart disease

• having elevated lipid profile at baseline (admission)

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Virgin Coconut Oil
Oral supplementation of virgin coconut oil to COVID-19 patients

Locations

Country	Name	City	State
Philippines	Philippine General Hospital	Manila	Metro Manila

Sponsors (3)

Lead Sponsor	Collaborator
University of the Philippines	Philippine Coconut Authority, Philippine Council for Health Research & Development

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Negative test result for COVID by RT-PCR	Negative test result for COVID by RT-PCR (within 3 days after the two week administration of VCO)	Two weeks
Primary	Duration of hospital stay	To determine if the VCO intervention can lessen the duration of stay in the hospital by at least 2 days	Two weeks
Primary	Time to recovery/resolution of symptoms	Patient will be assessed based on the following secondary outcome: time interval before ventilation, ICU and negative results on PCR swab test	Two weeks
Secondary	Time to first receipt of ventilation and admission to intensive care unit	monitor the duration by which symptoms progress to a point where patient may need intensive care unit admission and/or use of ventilation machine after onsent of VCO administration	Two weeks
Secondary	IL-6 levels (pg/mL)	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks
Secondary	Ferritin levels (ng/mL)	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks
Secondary	CRP levels (mg/dL)	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks
Secondary	LDH levels (mg/dL0	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks
Secondary	TNF-Alpha levels (pg/mL)	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks
Secondary	Interferon-gamma levels (pg/mL)	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks
Secondary	Monocyte chemoattractant protein levels (pg/mL)	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks
Secondary	Immunoglobulin levels (mg/L)	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks
Secondary	CD4+ counts (cells/L)	Peripheral blood (at most 5mL) will be collected from each patient at baseline, and every week thereafter until the end of study participation for secondary outcome emasurement (CD4+ cells). Blood extraction will coincide with blood collection for routine diagnostic workup of the patient. Laboratory results of other outcome parameters (ie IL6, CRP, ferritin, LDH) will be extracted from patient medical records (as aprt of routine work-up) or from patient database	Two weeks