SARS-CoV-2 coronavirus infection (COVID-19).
Conditions
Interventions
Trade Name: Hidroferol® 0.266 mg soft capsules.
Product Name: Hidroferol
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Or
Sponsors
FAES FARMA S.A.
Eligibility
Sex/Gender
All
Inclusion 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). 5. Only for women of reproductive age: availability to perform pregnancy tests; They should also agree to the use of highly effective birth control methods for the entire duration of the study, which include: combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal or transdermal), hormonal contraceptives of progesterone associated with inhibitors of the ovulation (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner (if such partner is the only sexual partner of the trial participant and has documentation of azoospermia) or sexual abstinence (defined as avoiding heterosexual sex for the entire risk period associated with trial treatment). The investigator is responsible for determining whether the patient is using an appropriate birth control method for study participation. 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 804 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 804
Exclusion criteria
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. 11. Patients with a current or previous history of neoplasia in the last five years. 12. History of previous hospitalization for COVID-19 or positive diagnostic test for SARS-CoV-2 before the current episode. 13. Women who are pregnant, nursing or planning a pregnancy. 14. Any other medical and / or therapeutic circumstance considered by the researcher that prevents adequate monitoring and / or adequate evolution of the response to the study treatment. 15. Patients who have received an investigational drug (including vaccines) or have used an investigational invasive medical device in the last 30 days prior to the start of the screening phase or are currently participating in another clinical trial. 16. Patients who have received the last dose of any of the approved SARS-CoV-2 vaccines less than 10 days prior to the start of the study; or who have not yet completed the vaccination. NOTE: If the doctor knows or suspects that the patient does not have the capacity to understand the implications of her participation in the study, he should not allow her to enter without the signature of a legal representative of the same.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of calcifediol in reducing hospital admissions in patients with a positive result for a diagnostic test for SARS-CoV-2 and at least one risk factor for the development of severe disease.;Secondary Objective: 1. To evaluate the safety of calcifediol in the treatment of patients with a positive result for SARS-CoV-2 and at least one risk factor. 2. Describe the frequency of admission to the intensive care unit (ICU) in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group. 3. Describe the frequency of mortality in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group. 4. Describe the morbidity and mortality in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group. 5. Describe the evolution of the symptoms related to COVID-19, reported by the patients themselves.;Primary end point(s): Percentage of patients who, being initially in outpatient follow-up, require hospital admission as a consequence of SARS-CoV-2 infection.;Timepoint(s) of evaluation of this end point: During all the clinical trial period, from the screening to the end of study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): During all the clinical trial period, from the screening to the end of study.;Timepoint(s) of evaluation of this end point: 1. Percentage of calcifediol-related adverse events 2. Percentage of patients who, being initially in outpatient follow-up, require admission to the ICU as a consequence of SARS-CoV-2 infection. 3. Percentage of patients who die as a result of SARS-CoV-2 infection. 4. Morbidity and mortality rate in patients. Death, hospital admission, or admission to the ICU are considered morbidity and mortality. 5. Change in symptoms related to COVID-19 with respect to baseline and with respect to the days of treatment completed, evaluated using a 5-point Likert scale. | — |
Countries
Spain
Contacts
Public ContactDepartamento de Operaciones
Dynamic Science S.L.
Outcome results
None listed