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

• ClinicalTrials.gov Identifier: NCT04849637
• Recruitment Status: Active, not recruiting
• First Posted: April 19, 2021
• Last Update Posted: March 8, 2022
• Sponsor: University of the Philippines
• Collaborators: Philippine Coconut Authority; Philippine Council for Health Research & Development
• Information provided by (Responsible Party): University of the Philippines

Study Description

Brief 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)

Condition or disease	Intervention/treatment	Phase
Covid19	Drug: Virgin Coconut Oil	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 74 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients
• Actual Study Start Date: October 22, 2020
• Estimated Primary Completion Date: April 9, 2022
• Estimated Study Completion Date: April 9, 2022

Arms and Interventions

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 Name: VCO
No Intervention: COVID-19 Standard of care treatment; Standard of care

Outcome Measures

Primary Outcome Measures :

1. Duration of hospital stay [ Time Frame: Two weeks ]
   To determine if the VCO intervention can lessen the duration of stay in the hospital by at least 2 days
2. Time to recovery/resolution of symptoms [ Time Frame: Two weeks ]
   Patient will be assessed based on the following secondary outcome: time interval before ventilation, ICU and negative results on PCR swab test

Secondary Outcome Measures :

1. Time to first receipt of ventilation and admission to intensive care unit [ Time Frame: Two weeks ]
   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
2. IL-6 levels (pg/mL) [ Time Frame: Two weeks ]
   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
3. Ferritin levels (ng/mL) [ Time Frame: Two weeks ]
   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
4. CRP levels (mg/dL) [ Time Frame: Two weeks ]
   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
5. LDH levels (mg/dL0 [ Time Frame: Two weeks ]
   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
6. TNF-Alpha levels (pg/mL) [ Time Frame: Two weeks ]
   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
7. Interferon-gamma levels (pg/mL) [ Time Frame: Two weeks ]
   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
8. Monocyte chemoattractant protein levels (pg/mL) [ Time Frame: Two weeks ]
   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
9. Immunoglobulin levels (mg/L) [ Time Frame: Two weeks ]
   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
10. CD4+ counts (cells/L) [ Time Frame: Two weeks ]
    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

Other Outcome Measures:

1. Negative test result for COVID by RT-PCR [ Time Frame: Two weeks ]
   Negative test result for COVID by RT-PCR (within 3 days after the two week administration of VCO)

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Locations

Philippines

Philippine General Hospital

Manila, Metro Manila, Philippines, 1000

Sponsors and Collaborators

University of the Philippines

Philippine Coconut Authority

Philippine Council for Health Research & Development

Investigators

• Principal Investigator: Marissa M Alejandria, MD; UP Manila
• Principal Investigator: Leslie Michelle M Dalmacio, PhD; UP Manila

More Information

• Responsible Party: University of the Philippines
• ClinicalTrials.gov Identifier: NCT04849637
• Other Study ID Numbers: UPMREB 2020-306-01
• First Posted: April 19, 2021
• Last Update Posted: March 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of the Philippines:

virgin coconut oil; COVID19

Additional relevant MeSH terms:

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