search
Back to results

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

Primary Purpose

Covid19

Status
Active
Phase
Phase 2
Locations
Philippines
Study Type
Interventional
Intervention
Virgin Coconut Oil
Sponsored by
University of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring virgin coconut oil, COVID19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Philippine General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Standard of care plus adjunctive virgin coconut oil supplementation

COVID-19 Standard of care treatment

Arm Description

Standard of care plus virgin coconut oil

Standard of care

Outcomes

Primary Outcome Measures

Duration of hospital stay
To determine if the VCO intervention can lessen the duration of stay in the hospital by at least 2 days
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

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
March 19, 2021
Last Updated
March 7, 2022
Sponsor
University of the Philippines
Collaborators
Philippine Coconut Authority, Philippine Council for Health Research & Development
search

1. Study Identification

Unique Protocol Identification Number
NCT04849637
Brief Title
Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients
Official Title
Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 22, 2020 (Actual)
Primary Completion Date
April 9, 2022 (Anticipated)
Study Completion Date
April 9, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Philippines
Collaborators
Philippine Coconut Authority, Philippine Council for Health Research & Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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)
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: Group receiving standard of care 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
virgin coconut oil, COVID19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care plus adjunctive virgin coconut oil supplementation
Arm Type
Experimental
Arm Description
Standard of care plus virgin coconut oil
Arm Title
COVID-19 Standard of care treatment
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Drug
Intervention Name(s)
Virgin Coconut Oil
Other Intervention Name(s)
VCO
Intervention Description
Oral supplementation of virgin coconut oil to COVID-19 patients
Primary Outcome Measure Information:
Title
Duration of hospital stay
Description
To determine if the VCO intervention can lessen the duration of stay in the hospital by at least 2 days
Time Frame
Two weeks
Title
Time to recovery/resolution of symptoms
Description
Patient will be assessed based on the following secondary outcome: time interval before ventilation, ICU and negative results on PCR swab test
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Time to first receipt of ventilation and admission to intensive care unit
Description
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
Time Frame
Two weeks
Title
IL-6 levels (pg/mL)
Description
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
Time Frame
Two weeks
Title
Ferritin levels (ng/mL)
Description
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
Time Frame
Two weeks
Title
CRP levels (mg/dL)
Description
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
Time Frame
Two weeks
Title
LDH levels (mg/dL0
Description
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
Time Frame
Two weeks
Title
TNF-Alpha levels (pg/mL)
Description
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
Time Frame
Two weeks
Title
Interferon-gamma levels (pg/mL)
Description
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
Time Frame
Two weeks
Title
Monocyte chemoattractant protein levels (pg/mL)
Description
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
Time Frame
Two weeks
Title
Immunoglobulin levels (mg/L)
Description
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
Time Frame
Two weeks
Title
CD4+ counts (cells/L)
Description
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
Time Frame
Two weeks
Other Pre-specified Outcome Measures:
Title
Negative test result for COVID by RT-PCR
Description
Negative test result for COVID by RT-PCR (within 3 days after the two week administration of VCO)
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marissa M Alejandria, MD
Organizational Affiliation
UP Manila
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leslie Michelle M Dalmacio, PhD
Organizational Affiliation
UP Manila
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philippine General Hospital
City
Manila
State/Province
Metro Manila
ZIP/Postal Code
1000
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs