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

COVID19 Clinical Trial

— COVIDIOL  

Official title:

Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366908
• Other study ID #: COVIDIOL
• Status: Completed
• Phase: Phase 2
• Start date: May 7, 2020
• Est. completion date: April 19, 2022

Study information

• Verified date: March 2023
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 517
• Est. completion date: April 19, 2022
• Est. primary completion date: April 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• COVID19
• Cytokine Release Syndrome
• Cytokine Storm
• SARS (Severe Acute Respiratory Syndrome)
• SARS-CoV 2
• Severe Acute Respiratory Syndrome
• Syndrome

Intervention

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
• 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).

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Cordoba

Sponsors (4)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Dynamic Solutions, Faes Farma, S.A., Junta de Andalucía - Consejería de Salud y Familias, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission to Intensive Care Unit	Proportion of subjects who enter the Intensive Care Unit	At day 28.
Primary	Death	Proportion of subjects who die.	At day 28.
Secondary	Time from onset of symptoms to discharge of patients in conventional hospitalization	Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.	At day 28.
Secondary	ICU - Time until admission	In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit	At day 28.
Secondary	ICU - Time mechanical ventilation is removed	In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed.	At day 28.
Secondary	Evaluation of the inflammatory markers related with the disease	Evaluation of the inflammatory markers related to IL disease. Blood samples will be collected and assessed in order to evaluate interleukins related with the interleukin storm using immunological tests.	At day 28.
Secondary	Vitamin D metabolites	Evaluation of the Vitamin D metabolites.	At day 28.
Secondary	Evolution in SatO2	Compare the evolution in SatO2	At day 28.
Secondary	Evolution in the Sat O2/FiO2 ratio.	Compare the evolution in the Sat O2/FiO2 ratio	At day 28.
Secondary	Evolution in the degree of dyspnea	Compare the evolution in the degree of dyspnea using the analog Borg scale	At day 28.
Secondary	Evolution of the improvement of radiological findings by simple radiology	Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial	At day 28.
Secondary	Incidence of adverse events	Incidence of adverse events related to medication and its administration.	At day 28.
Secondary	Appearance of hemorrhagic or thrombotic phenomena	Incidence in the appearance of hemorrhagic or thrombotic phenomena.	At day 28.