COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04344041

Cédric ANNWEILER

cedric.annweiler@chu-angers.fr

2020-04-14

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: - 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

- 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

2

University Hospital, Angers

65

None

France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

260

Number of death of any cause, during the 14 days following the inclusion and intervention.

None

Phase 3

[{"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1370, "treatment_name": "Vitamin d", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}]