NCT04403932

Brief Summary

In this prospective observational study we aim to study the association of vitamin D deficiency with adverse clinical outcomes in patients infected with Coronavirus disease 2019

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 17, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

May 24, 2020

Last Update Submit

January 29, 2021

Conditions

Keywords

Coronavirus Disease 2019 (COVID-19)Vitamin D DeficiencySevere Acute Respiratory SyndromeAngiotensin Converting Enzyme 2

Outcome Measures

Primary Outcomes (1)

  • severe COVID-19

    death, admission to the intensive care unit, and/or a need for higher oxygen flow than that provided by nasal cannula

    17/04/2020 to 01/06/2020

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive adult subjects attending the emergency department with symptoms suggestive of COVID-19 and a positive reverse-transcriptase polymerase chain reaction for SARS-CoV-2

You may qualify if:

  • \>18 years old
  • symptoms suggestive of COVID-19
  • positive reverse-transcriptase polymerase chain reaction or antibodies for SARS-CoV-2

You may not qualify if:

  • Bacterial community acquired pneumonia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

COVID-19Vitamin D DeficiencySevere Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 24, 2020

First Posted

May 27, 2020

Study Start

April 17, 2020

Primary Completion

June 1, 2020

Study Completion

August 1, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations