EUCTR2020-001793-30-DK
Active, not recruiting
Phase 1
Preventing Disease Aggravation in COVID-19 by high dose Vitamin D: a randomized trial (COVIT-D) - COVIT-D
Copenhagen University Hospital of Bispebjerg0 sites480 target enrollmentMay 24, 2020
ConditionsSARS-COV-2 positive patientsMedDRA version: 23.0Level: LLTClassification code 10084382Term: Coronavirus disease 2019System Organ Class: 100000004862MedDRA version: 20.0Level: PTClassification code 10050713Term: Vitamin DSystem Organ Class: 10022891 - InvestigationsMedDRA version: 20.0Level: LLTClassification code 10013097Term: Disease aggravationSystem Organ Class: 100000004867Therapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsBenferol
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- SARS-COV-2 positive patients
- Sponsor
- Copenhagen University Hospital of Bispebjerg
- Enrollment
- 480
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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