EUCTR2021-000316-31-ES
Active, not recruiting
Phase 1
Multicenter, double-blind, randomized clinical trial to evaluate the efficacy of calcifediol soft capsules versus placebo in reducing hospital admissions in patients with a positive diagnostic test for SARS-CoV-2. - IMMUNOCOVIDIO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- FAES FARMA S.A.
- Enrollment
- 804
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age: over 18 years old
- •2\. Patient with a suspected respiratory clinical picture of COVID\-19, confirmed with a positive result either by PCR for SARS\-CoV\-2 of nasopharyngeal exudate with or without oropharyngeal exudate; and / or rapid antigen detection test (Antigen Rapid Diagnostic Test, Ag\-RDT) of nasal or nasopharyngeal exudate.
- •The result of any of the diagnostic tests must be available within 72 hours of the onset of the clinical picture.
- •3\. Present at least one of the following risk factors for the development of serious disease:
- •o Age \= 60 years
- •o Body mass index (BMI) \= 30 kg / cm2
- •o Chronic cardiovascular disease
- •o Chronic respiratory disease
- •o Chronic kidney disease
- •4\. Voluntary signing of the Informed Consent (IC).
Exclusion Criteria
- •1\. Subjects who have been treated with calcifediol or cholecalciferol continuously and in doses greater than or equal to 0\.266 mg / month or 800 IU / day, respectively, during the last 3 months.
- •2\. Subjects who have taken or are required to take medications that can modify vitamin D levels within the last week before enrollment or during the study: phenobarbital, phenytoin, primidone, digoxin, rifampin, thiazide diuretics (hydrochlorothiazide), some antibiotics (penicillin, neomycin and chloramphenicol), antiretrovirals (tenofovir, adefovir), oral chronic corticosteroids (defined as a dose of prednisolone \= 5 mg daily or equivalent) for more than 3 months, verapamil, paraffin, mineral oil laxatives, magnesium salts, actinomycin, and antifungal imidazoles. Subjects taking orlistat, cholestyramine, or colestipol who do not observe a time interval of at least 2 hours with respect to taking study medication.
- •3\. History of hypersensitivity to any of the active ingredients or components of the investigational drug (IM).
- •4\. Subjects who have taken calcium supplements within the last week before inclusion, or who require to take them during the study.
- •5\. Uncorrected hypercalcemia (serum calcium\> 10\.5 mg / dL), known hypercalciuria, or history of nephrolithiasis.
- •6\. Severe kidney disease, defined by CKD\-EPI estimated glomerular filtration rate (GFR) \<30 mL / min / 1\.73m2
- •7\. Diagnosis of liver failure, exacerbated congestive heart failure, malabsorption, primary hyperparathyroidism, hypoparathyroidism, prolonged immobilization, sarcoidosis, tuberculosis, or other granulomatous diseases.
- •8\. Presence of serious illness that requires direct hospital admission or that due to its characteristics does not allow oral treatment.
- •9\. Persons admitted to an institution by order of judicial authorities or other authorities.
- •10\. People who cannot collaborate with the study procedures.
Outcomes
Primary Outcomes
Not specified
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