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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04366908
Other study ID # COVIDIOL
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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