Clinical trial NCT04366908: Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome
Official title: Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: SARS-CoV 2
COVID19
SARS (Severe Acute Respiratory Syndrome)
Cytokine Release Syndrome
Cytokine Storm
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Junta de Andalucia
name: Dynamic Solutions
name: Faes Farma, S.A.
First posted: 2020-04-29
Enrollment: 517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Admission to Intensive Care Unit
timeFrame: At day 28.
measure: Death
timeFrame: At day 28.
Secondary outcomes:
measure: Time from onset of symptoms to discharge of patients in conventional hospitalization
timeFrame: At day 28.
measure: ICU - Time until admission
timeFrame: At day 28.
measure: ICU - Time mechanical ventilation is removed
timeFrame: At day 28.
measure: Evaluation of the inflammatory markers related with the disease
timeFrame: At day 28.
measure: Vitamin D metabolites
timeFrame: At day 28.
measure: Evolution in SatO2
timeFrame: At day 28.
measure: Evolution in the Sat O2/FiO2 ratio.
timeFrame: At day 28.
measure: Evolution in the degree of dyspnea
timeFrame: At day 28.
measure: Evolution of the improvement of radiological findings by simple radiology
timeFrame: At day 28.
measure: Incidence of adverse events
timeFrame: At day 28.
measure: Appearance of hemorrhagic or thrombotic phenomena
timeFrame: At day 28.
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
affiliation: Hospital Universitario Reina Sofía
name: José López Miranda, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stroehlein JK, Wallqvist J, Iannizzi C, Mikolajewska A, Metzendorf MI, Benstoem C, Meybohm P, Becker M, Skoetz N, Stegemann M, Piechotta V. Vitamin D supplementation for the treatment of COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 24;5(5):CD015043. doi: 10.1002/14651858.CD015043.