Covid19
Conditions
Keywords
virgin coconut oil, COVID19
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: 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
Interventions
Oral supplementation of virgin coconut oil to COVID-19 patients
Sponsors
Philippine Coconut Authority
Philippine Council for Health Research & Development
University of the Philippines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to recovery/resolution of symptoms | Two weeks | Patient will be assessed based on the following secondary outcome: time interval before ventilation, ICU and negative results on PCR swab test |
| Duration of hospital stay | Two weeks | To determine if the VCO intervention can lessen the duration of stay in the hospital by at least 2 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-6 levels (pg/mL) | 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 |
| Ferritin levels (ng/mL) | 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 |
| CRP levels (mg/dL) | 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 |
| LDH levels (mg/dL0 | 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 |
| Interferon-gamma levels (pg/mL) | 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 |
| Monocyte chemoattractant protein levels (pg/mL) | 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 |
| Immunoglobulin levels (mg/L) | 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 |
| CD4+ counts (cells/L) | 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 |
| TNF-Alpha levels (pg/mL) | 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 |
| Time to first receipt of ventilation and admission to intensive care unit | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Negative test result for COVID by RT-PCR | Two weeks | Negative test result for COVID by RT-PCR (within 3 days after the two week administration of VCO) |
Countries
Philippines
Outcome results
None listed