Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Dynamic Solutions; FAES Farma; Faes Farma, S.A.; Junta de Andalucía - Consejería de Salud y Familias, Spain
• Treatments: Calcifediol

Criteria

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