Vitamin D on Prevention and Treatment of COVID-19 (COVITD-19)
Primary Purpose
Patients Infected With COVID-19
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional treatment trial for Patients Infected With COVID-19
Eligibility Criteria
Inclusion Criteria:
- Non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections.
Exclusion Criteria:
- Patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced COVID-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).
Sites / Locations
- Universidad de Granada
- Medicine Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
Intervention group
Arm Description
Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.
25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.
Outcomes
Primary Outcome Measures
Composite of cumulative death (i.e. mortality) for all causes and for specific causes.
Secondary Outcome Measures
Necessity of invasive assisted ventilation
Necessity of non-invasive assisted ventilation
Intensive care unit admission
Post-anesthesia care unit admission
Hospital admission
Medical consultation
Home care and isolation time
Bed rest time
symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19)
Subjective perception of recovery
It will be measure by questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04334005
Brief Title
Vitamin D on Prevention and Treatment of COVID-19
Acronym
COVITD-19
Official Title
Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2020 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The new outbreak of the SARS-CoV-2 coronavirus is causing an important pandemic affecting a large number of people all-over the world. Vitamin D is a hormone precursor produced by our own body with the help of sunlight which has an important role on adaptive immunity and cellular differentiation, maturation and proliferation of several immune cells. Reduced levels of vitamin D in calves were positioned as the main cause of bovine coronavirus infection in the past. Therefore, it seems plausible that the use of vitamin D as a nutritional ergogenic aid could be a potential intervention to fight against COVID-19 infected patients which remain asymptomatic or which have non-severe and severe symptoms. This study aims to investigate whether the use of vitamin D as an immune modulator agent induces significant improvements of health status and outcomes in non-severe symptomatic patients infected with COVID-19 as well as preventing COVID-19 health deterioration. We hypothesize that vitamin D will significantly improve hard endpoints related to COVID-19 deleterious consequences compared with a usual care control group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients Infected With COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
25000 UI of vitamin D supplement in addition to the above-mentioned drug recommendations.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
The intervention group will receive a single dose of 25000 UI of vitamin D supplement in addition to prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations. Vitamin D supplementation will be taken in the morning together with a toast with olive oil to facilitate its absorption.
Primary Outcome Measure Information:
Title
Composite of cumulative death (i.e. mortality) for all causes and for specific causes.
Time Frame
Through study completion, an average of 10 weeks
Secondary Outcome Measure Information:
Title
Necessity of invasive assisted ventilation
Time Frame
Through study completion, an average of 10 weeks
Title
Necessity of non-invasive assisted ventilation
Time Frame
Through study completion, an average of 10 weeks
Title
Intensive care unit admission
Time Frame
Through study completion, an average of 10 weeks
Title
Post-anesthesia care unit admission
Time Frame
Through study completion, an average of 10 weeks
Title
Hospital admission
Time Frame
Through study completion, an average of 10 weeks
Title
Medical consultation
Time Frame
Through study completion, an average of 10 weeks
Title
Home care and isolation time
Time Frame
Through study completion, an average of 10 weeks
Title
Bed rest time
Time Frame
Through study completion, an average of 10 weeks
Title
symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19)
Time Frame
Through study completion, an average of 10 weeks
Title
Subjective perception of recovery
Description
It will be measure by questionnaire
Time Frame
Through study completion, an average of 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Non-severe symptomatic patients who present cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia or alternative signs of respiratory infections.
Exclusion Criteria:
Patients presenting severe respiratory and/or multisystemic symptoms compatible with advanced COVID-19 and intercurrent acute or severe chronic diseases (i.e. active cancer).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel J Castillo, MD, PhD
Phone
+34 649440850
Email
mcgarzon@ugr.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel J Castillo, MD, PhD
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Granada
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18071
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel J. Castillo Garzón
Email
mcgarzon@ugr.es
Facility Name
Medicine Faculty
City
Granada
ZIP/Postal Code
18001
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Proffesor Amaro Gahete, PhD student
Phone
697287022
Ext
+34
Email
amarof@ugr.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Vitamin D on Prevention and Treatment of COVID-19
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