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.
Drug: BAT + Calcifediol
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
Drug: BAT
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).
Inclusion Criteria:
- Age ≥ 18 and < 90 years
- PCR confirmed diagnosis of COVID-19. 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
Hospital Universitario Reina Sofía
Cordoba, Spain
José López Miranda, MD, Principal Investigator
Hospital Universitario Reina Sofía