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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Covid19

Intervention / Treatment
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* Drug: Virgin Coconut Oil


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virgin coconut oil, COVID19