NCT04849637

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Oct 2020

Longer than P75 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2022

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

March 19, 2021

Last Update Submit

March 7, 2022

Conditions

Keywords

virgin coconut oilCOVID19

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (10)

  • Time to first receipt of ventilation and admission to intensive care unit

    Two weeks

  • IL-6 levels (pg/mL)

    Two weeks

  • Ferritin levels (ng/mL)

    Two weeks

  • CRP levels (mg/dL)

    Two weeks

  • LDH levels (mg/dL0

    Two weeks

  • +5 more secondary outcomes

Other Outcomes (1)

  • Negative test result for COVID by RT-PCR

    Two weeks

Study Arms (2)

Standard of care plus adjunctive virgin coconut oil supplementation

EXPERIMENTAL

Standard of care plus virgin coconut oil

Drug: Virgin Coconut Oil

COVID-19 Standard of care treatment

NO INTERVENTION

Standard of care

Interventions

Oral supplementation of virgin coconut oil to COVID-19 patients

Also known as: VCO
Standard of care plus adjunctive virgin coconut oil supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic and asymptomatic COVID-19 hospitalized patients
  • has laboratory-confirmed illness during the time of recruitment
  • able to take food and medicines enterally

You may not qualify if:

  • uncontrolled or newly diagnosed diabetes mellitus
  • with chronic heart disease
  • having elevated lipid profile at baseline (admission)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philippine General Hospital

Manila, National Capital Region, 1000, Philippines

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marissa M Alejandria, MD

    UP Manila

    PRINCIPAL INVESTIGATOR
  • Leslie Michelle M Dalmacio, PhD

    UP Manila

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

April 19, 2021

Study Start

October 22, 2020

Primary Completion

April 9, 2022

Study Completion

April 9, 2022

Last Updated

March 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations