High dose Vitamin D in Preventing Aggravation of COVID-19

Phase 1

• Conditions: SARS-COV-2 positive patients; MedDRA version: 20.0Level: PTClassification code 10050713Term: Vitamin DSystem Organ Class: 10022891 - Investigations; MedDRA version: 23.0Level: LLTClassification code 10084382Term: Coronavirus disease 2019System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 20.0Level: LLTClassification code 10013097Term: Disease aggravationSystem Organ Class: 100000004867

• Registration Number: EUCTR2020-001793-30-DK
• Lead Sponsor: Copenhagen University Hospital of Bispebjerg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-24
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

1 Age>=50 years
2 Positive test for SARS-COV-2
3 Signed informed Consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 380

Exclusion Criteria

1) Need for immediate hospital admission
2) Known hypercalcemia or hyperparathyroidism
3) Significant kidney disease needing dialysis
4) Known kidney stone or nephrocalcinosis
5) Pregnancy or no-anti-conception in fertile women*
6) Regular user of supplemental Vitamin D (>=20 µg /day > one month) or
7) Known intolerance to Vitamin D

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether treatment with a single high-dose of Vitamin D3 25000 IU (625µg) versus placebo in SARS-COV-2 positive patients, will reduce disease-aggravation defined as need for hospital-admission and duration of hospitalization or death in home-based patients.;Secondary Objective: Not applicable;Primary end point(s): Disease aggravation defined as: Combined endpoint of death and duration of hospitalization, calculated as Days Alive and Out of Hospital (DAOH) in a Time Frame of 6 weeks (42 days). ;Timepoint(s) of evaluation of this end point: 6 weeks (42 days)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a) Rate of combined death or hospitalization <br>b) All-cause mortality<br>c) Percentage of ended infection”** in the first month after inclusion (**: recovered” COVID-19 - according to the definition of Statens Serum Institute (SSI)).<br>;Timepoint(s) of evaluation of this end point: 6 weeks (42 days)