Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 517
- Locations
- 1
- Primary Endpoint
- Admission to Intensive Care Unit
Study Overview
Brief Summary
The administration of Calcifediol in patients with COVID-19, will reduce the development of SARS and the worsening of the various phases of the syndrome. Reducing at least 25% in ICU admission and death from the process, reducing days of hospitalization, facilitating the recovery of the same, acting significantly and positively, in any of its phases throughout the natural history of illness.
As a treatment with extensive experience of clinical use, safe, inexpensive, and potentially very effective, it will have a highly efficient cost-benefit impact on the prevention of SARS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 and < 90 years
- •PCR confirmed diagnosis of COVID-
- •As an alternative to PCR, a determination of antigens or any other test that in the future is considered equivalent to these in its diagnostic value may be accepted as evidence
- •Radiological image compatible with inflammatory pleuropulmonary exudate or patients with onset of symptoms in the last 7 days and with an uncomplicated respiratory infection for outpatient follow-up.
- •Signature of direct or delegated informed consent
Exclusion Criteria
- •Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages
- •Intolerance or allergy to Calcifediol or its components
- •Pregnancy
Arms & Interventions
Control - best available therapy
The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS).
Intervention: BAT (Drug)
Treatment
The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS) plus Calcifediol caps. 266 µg. According to the pharmacokinetics of Calcifediol evaluated in an inflammatory model, the posology will be
- Start: 2 capsules
- Days 3, 7, 14, 21, 28: 1 capsule
Intervention: BAT + Calcifediol (Drug)
Outcomes
Primary Outcomes
Admission to Intensive Care Unit
Time Frame: At day 28.
Proportion of subjects who enter the Intensive Care Unit
Death
Time Frame: At day 28.
Proportion of subjects who die.
Secondary Outcomes
- ICU - Time mechanical ventilation is removed(At day 28.)
- Evaluation of the inflammatory markers related with the disease(At day 28.)
- Vitamin D metabolites(At day 28.)
- Evolution in SatO2(At day 28.)
- Evolution in the Sat O2/FiO2 ratio.(At day 28.)
- Time from onset of symptoms to discharge of patients in conventional hospitalization(At day 28.)
- ICU - Time until admission(At day 28.)
- Evolution in the degree of dyspnea(At day 28.)
- Evolution of the improvement of radiological findings by simple radiology(At day 28.)
- Incidence of adverse events(At day 28.)
- Appearance of hemorrhagic or thrombotic phenomena(At day 28.)