Status:
COMPLETED
COvid-19 and Vitamin D Supplementation: a Multicenter Randomized Controlled Trial of High Dose Versus Standard Dose Vitamin D3 in High-risk COVID-19 Patients (CoVitTrial)
Lead Sponsor:
University Hospital, Angers
Collaborating Sponsors:
Mylan Laboratories
Conditions:
Coronavirus
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
Vitamin D is a secosteroid hormone produced by the skin during Summer exposure to UVB rays. Hypovitaminosis D is common in Winter (October to March) at Northern latitudes above 20 degrees North, and f...
Detailed Description
• Inclusion visit A clinical examination is carried out. Social-demographic measures, health history, clinical examination measures (including OSCI score) and biological measures are collected. Rando...
Eligibility Criteria
Inclusion
- Age ≥ 65 years old
- Infection with COVID-19 diagnosed with RT-PCR SARS-CoV-2 or withCT-scan of the chest suggesting viral pneumonia of peripheral predominance in a clinically relevant context
- Patient seen in hospitalization or consultation or in nursing home
- Diagnosed within the preceding 3 days
- Having at least one of the following two risk factors for complications:
- age ≥75 years
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg
- Patients affiliated with or benefitting from a social security scheme
- Written and signed consent of the patient or a relative or legal representative or, if not possible, emergency inclusion procedure
Exclusion
- Organ failure requiring admission to a resuscitation or high dependency unit
- Comorbidity that is life-threatening in the short-term (life expectancy \<3 months)
- Any reason that makes follow-up at day 28 impossible
- Vitamin D supplementation in the previous month, with the exception of treatment providing less than 800 IU of vitamin D per day
- Contraindication for vitamin D supplementation: active granulomatosis (sarcoidosis, tuberculosis, lymphoma), history of calcic lithiasis, known hypervitaminosis D or hypercalcemia, known intolerance to vitamin D
- Participation in another simultaneous trial
- Safeguard of justice
- Peripheral capillary oxygen saturation (SpO2) ≤92% in spite of an oxygen therapy \> 5L/min
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2021
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04344041
Start Date
April 15 2020
End Date
January 14 2021
Last Update
April 30 2021
Active Locations (9)
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1
CHU Angers
Angers, France
2
CHU Bordeaux
Bordeaux, France
3
CH Le Mans
Le Mans, France
4
CHU Limoges
Limoges, France