Cholecalciferol to Improve the Outcomes of COVID-19 Patients

Summary

The recent inception of the coronavirus SARS-CoV-2, responsible for the coronavirus disease (COVID-19), has caused thousands of deaths globally. The most frequently reported complications among COVID-19 patients are from respiratory involvement.

Vitamin D has immunomodulatory effects that could protect against COVID-19 infection. Indeed, there is good evidence from randomized clinical trials suggesting that high doses of vitamin D administered during cold seasons prevent viral respiratory infections in at risk individual, and more recently, observational studies suggested that the mortality rate from COVID-19 is inversely correlated with levels of serum 25(OH)vitamin D.

The hypothesis of the study is that a high dose of vitamin D given orally to patients admitted to the hospital for COVID-19 will prevent the occurrence of respiratory deragement and other adverse clinical events.

To evaluate the aforementioned hypothesis, a randomized, controlled, double-blind, clinical trial comparing a 500.000 UI dose of vitamin D versus placebo among COVID-19 patients at moderate risk, requiring hospitalization but without requirements of critical care at admission was designed. The intervention will be one dose of 500.000 UI given orally or matching placebo.

The trial has a sequential design with two steps:

* The first step, projected to include 200 patients, will assess the effects of the intervention on the respiratory SOFA; and
* If there is a detectable effects, the second step, projected to include 1264 patients, will assess the effects on a combined event that includes need of high dose of oxygen or mechanical ventilation.

All study outcomes will be measured during the index hospitalization.

Conditions

• COVID

Interventions

DRUG

Vitamin D

5 capsules of 100.000 UI Vitamin D orally given all at once. One dose.

DRUG

Placebo

5 capsules of containing placebo orally given all at once. One dose.

Sponsors & Collaborators

• Agencia Nacional de Investigación y Desarrollo

  collaborator OTHER

• Vitamin D Study Group

  lead NETWORK

Principal Investigators

• Walter Manucha, PhD · IMBECU, Univ Nac de Cuyo, Mendoza, Argentina

• Carlos Tajer, MD · Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche

• Laura Antonietti, MD · Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche

• León Ferder, MD · Maimonides University

• Felipe Inserra, MD · Universidad Maimónides - Hospital Universitario Austral

• Javier Mariani, MD · Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-11

Primary Completion

2021-07-28

Completion

2021-07-28

Countries

• Argentina

Study Locations