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

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV 2; COVID19; Cytokine Storm; Cytokine Release Syndrome; SARS (Severe Acute Respiratory Syndrome)
• Intervention / Treatment: Drug: BAT; Drug: BAT + Calcifediol

• Study Type: Interventional
• Enrollment (Actual): 517
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: José Manuel Quesada Gómez, MD; Phone Number: 0034671596070; Email: md1qugoj@uco.es
• Study Contact Backup: Name: Antonio Luque, MsC; Phone Number: 0034671596070; Email: uicec@imibic.org

Study Locations

• Spain
  • Cordoba, Spain, 14001
    • Hospital Universitario Reina Sofia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control - best available therapy; 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).	Drug: 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).
Experimental: Treatment; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Admission to Intensive Care Unit	Proportion of subjects who enter the Intensive Care Unit	At day 28.
Death	Proportion of subjects who die.	At day 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
Vitamin D metabolites	Evaluation of the Vitamin D metabolites.	At day 28.
Evolution in SatO2	Compare the evolution in SatO2	At day 28.
Evolution in the Sat O2/FiO2 ratio.	Compare the evolution in the Sat O2/FiO2 ratio	At day 28.
Evolution in the degree of dyspnea	Compare the evolution in the degree of dyspnea using the analog Borg scale	At day 28.
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.
Incidence of adverse events	Incidence of adverse events related to medication and its administration.	At day 28.
Appearance of hemorrhagic or thrombotic phenomena	Incidence in the appearance of hemorrhagic or thrombotic phenomena.	At day 28.

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Dynamic Solutions; Faes Farma, S.A.; Junta de Andalucía - Consejería de Salud y Familias, Spain
• Investigators: Principal Investigator: José López Miranda, MD, Hospital Universitario Reina Sofia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2020
• Primary Completion (Actual): April 19, 2022
• Study Completion (Actual): April 19, 2022

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Estimate): March 3, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease; Shock; Severe Acute Respiratory Syndrome; COVID-19; Syndrome; Cytokine Release Syndrome; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcifediol
• Other Study ID Numbers: COVIDIOL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All the information will be published and accessible. It will be also available on demand.
• IPD Sharing Time Frame: Since the end publication of the results.
• IPD Sharing Access Criteria: Contact uicec@imibic.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No