Covid19Phase 2NCT04849637
Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients
A Phase 2 study testing Virgin Coconut Oil in people with Covid19, run by University of the Philippines at 1 site in Philippines.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Virgin Coconut Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePhilippines
- Study dates
- 22 Oct 2020to 9 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic and asymptomatic COVID-19 hospitalized patients
- has laboratory-confirmed illness during the time of recruitment
- able to take food and medicines enterally
Who cannot join
- uncontrolled or newly diagnosed diabetes mellitus
- with chronic heart disease
- having elevated lipid profile at baseline (admission)
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital
Manila, National Capital Region, 1000
About this study
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)
Read the 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
- Conditions
- Covid19
- Being tested
- Virgin Coconut Oil
- Keywords
- virgin coconut oil, COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virgin Coconut OilDrug
Also called VCO
Oral supplementation of virgin coconut oil to COVID-19 patients
| Study group | Role | What they receive |
|---|---|---|
| Standard of care plus adjunctive virgin coconut oil supplementation | Experimental | Standard of care plus virgin coconut oil Receives: Drug: Virgin Coconut Oil |
| COVID-19 Standard of care treatment | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospital stay
To determine if the VCO intervention can lessen the duration of stay in the hospital by at least 2 days
Measured: 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
Measured: Two weeks
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start22 Oct 2020
- Primary completion9 Apr 2022 (estimated)
- Study completion9 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Philippine Coconut Authority, Philippine Council for Health Research & Development
- Responsible party
- Sponsor
- Investigators
- Marissa M Alejandria, MD, Principal investigator, UP ManilaLeslie Michelle M Dalmacio, PhD, Principal investigator, UP Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849637
- Sponsor's protocol ID
- UPMREB 2020-306-01
- Status last verified
- Mar 2022
- First submitted
- 19 Mar 2021
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virgin Coconut Oil as Adjunctive Therapy for Hospitalized COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04849637
- Acronym / sponsor ID
- UPMREB 2020-306-01
- Conditions
- Covid19
- Keywords
- virgin coconut oil, COVID19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Philippine Coconut Authority, Philippine Council for Health Research & Development
- Study start
- 22 Oct 2020 (actual)
- Primary completion
- 9 Apr 2022 (estimated)
- Study completion
- 9 Apr 2022 (estimated)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care plus adjunctive virgin coconut oil supplementation | Experimental | Drug: Virgin Coconut OilStandard of care plus virgin coconut oil |
| COVID-19 Standard of care treatment | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- symptomatic and asymptomatic COVID-19 hospitalized patients
- has laboratory-confirmed illness during the time of recruitment
- able to take food and medicines enterally
Key exclusion criteria (3 listed)
- uncontrolled or newly diagnosed diabetes mellitus
- with chronic heart disease
- having elevated lipid profile at baseline (admission)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virgin Coconut OilAlso: VCOOral supplementation of virgin coconut oil to COVID-19 patients | Drug | Standard of care plus adjunctive virgin coconut oil supplementation |
Primary outcome
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
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
10 secondary outcomes
Time to first receipt of ventilation and admission to intensive care unit
Time frame: Two weeks
IL-6 levels (pg/mL)
Time frame: Two weeks
Ferritin levels (ng/mL)
Time frame: Two weeks
CRP levels (mg/dL)
Time frame: Two weeks
LDH levels (mg/dL0
Time frame: Two weeks
TNF-Alpha levels (pg/mL)
Time frame: Two weeks
Interferon-gamma levels (pg/mL)
Time frame: Two weeks
Monocyte chemoattractant protein levels (pg/mL)
Time frame: Two weeks
Immunoglobulin levels (mg/L)
Time frame: Two weeks
CD4+ counts (cells/L)
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa M Alejandria, MD principal investigator
UP Manila
Leslie Michelle M Dalmacio, PhD principal investigator
UP Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virgin Coconut Oil in people with Covid19, run by University of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of hospital stay (time frame: Two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.