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

Phase 2

Completed

• Conditions: Cytokine Storm; SARS (Severe Acute Respiratory Syndrome); COVID19; SARS-CoV 2; Cytokine Release Syndrome
• Interventions: Drug: BAT + Calcifediol; Drug: BAT

• Registration Number: NCT04366908
• Lead Sponsor: Maimónides Biomedical Research Institute of Córdoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Study Start: 2020-05-07
• Primary Completion: 2022-04-19
• Study Completion: 2022-04-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 517

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

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Exclusion Criteria

• Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages
• Intolerance or allergy to Calcifediol or its components
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	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
Control - best available therapy	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).

Primary Outcome Measures

Name	Time	Method
Admission to Intensive Care Unit	At day 28.	Proportion of subjects who enter the Intensive Care Unit
Death	At day 28.	Proportion of subjects who die.

Secondary Outcome Measures

Name	Time	Method
ICU - Time mechanical ventilation is removed	At day 28.	In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed.
Evaluation of the inflammatory markers related with the disease	At day 28.	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.
Vitamin D metabolites	At day 28.	Evaluation of the Vitamin D metabolites.
Evolution in SatO2	At day 28.	Compare the evolution in SatO2
Evolution in the Sat O2/FiO2 ratio.	At day 28.	Compare the evolution in the Sat O2/FiO2 ratio
Time from onset of symptoms to discharge of patients in conventional hospitalization	At day 28.	Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.
ICU - Time until admission	At day 28.	In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit
Evolution in the degree of dyspnea	At day 28.	Compare the evolution in the degree of dyspnea using the analog Borg scale
Evolution of the improvement of radiological findings by simple radiology	At day 28.	Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial
Incidence of adverse events	At day 28.	Incidence of adverse events related to medication and its administration.
Appearance of hemorrhagic or thrombotic phenomena	At day 28.	Incidence in the appearance of hemorrhagic or thrombotic phenomena.

Trial Locations

Locations (1)

Hospital Universitario Reina Sofía; 🇪🇸 Cordoba, Spain