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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: Virgin Coconut Oil

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Philippines
  • Metro Manila
    • Manila, Metro Manila, Philippines, 1000
      • Philippine General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standard of care plus adjunctive virgin coconut oil supplementation; Standard of care plus virgin coconut oil	Drug: Virgin Coconut Oil; Oral supplementation of virgin coconut oil to COVID-19 patients; Other Names: VCO
No Intervention: COVID-19 Standard of care treatment; Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of the Philippines
• Collaborators: Philippine Council for Health Research & Development; Philippine Coconut Authority
• Investigators: Principal Investigator: Marissa M Alejandria, MD, UP Manila; Principal Investigator: Leslie Michelle M Dalmacio, PhD, UP Manila

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2020
• Primary Completion (Anticipated): April 9, 2022
• Study Completion (Anticipated): April 9, 2022

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: COVID19; virgin coconut oil
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: UPMREB 2020-306-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No