Clinical trial NCT04334005: Vitamin D on Prevention and Treatment of COVID-19
Official title: Effect of Vitamin D Administration on Prevention and Treatment of Mild Forms of Suspected Covid-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Infected With COVID-19
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Composite of cumulative death (i.e. mortality) for all causes and for specific causes.
timeFrame: Through study completion, an average of 10 weeks
Secondary outcomes:
measure: Necessity of invasive assisted ventilation
timeFrame: Through study completion, an average of 10 weeks
measure: Necessity of non-invasive assisted ventilation
timeFrame: Through study completion, an average of 10 weeks
measure: Intensive care unit admission
timeFrame: Through study completion, an average of 10 weeks
measure: Post-anesthesia care unit admission
timeFrame: Through study completion, an average of 10 weeks
measure: Hospital admission
timeFrame: Through study completion, an average of 10 weeks
measure: Medical consultation
timeFrame: Through study completion, an average of 10 weeks
measure: Home care and isolation time
timeFrame: Through study completion, an average of 10 weeks
measure: Bed rest time
timeFrame: Through study completion, an average of 10 weeks
measure: symptoms' duration (i.e. cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, anosmia, ageusia, diarrhea or alternative signs of COVID-19)
timeFrame: Through study completion, an average of 10 weeks
measure: Subjective perception of recovery
timeFrame: Through study completion, an average of 10 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Universidad de Granada
state: Andalucia
city: Granada
country: Spain
facility: Medicine Faculty
Study officials:
affiliation: Universidad de Granada
name: Manuel J Castillo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: