Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19). (COVIDIOL)

February 25, 2024 updated by: Complejo Hospitalario Universitario de Albacete

Inclusion of Calcifediol in the Hospital Therapeutic Protocol for Treatment of SARS-CoV-2 Disease (COVID-19). Mortality Analysis. Retrospective Study.

Descriptive, retrospective, observational, anonymous, study to evaluate the potential effect of incorporating calcifediol into the therapeutic protocol of patients hospitalized for COVID-19 on mortality and other outcome variables, such as admission to the Intensive Care Unit (ICU), to "Gerencia de Atención Integrada (GAI) de Albacete". "Complejo Hospitalario Universitario de Albacete". Albacete (Spain)", based on the files of the MXXI medical records, Information System of the Laboratory (ISL) and Pharmacy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The coronavirus disease-19 (COVID-19) pandemic, caused by the severe acute respiratory syndrome β-coronavirus (SARS-CoV-2), is one of the greatest challenges facing modern medicine and public health systems worldwide [1]. Since its appearance in December 2019[2], it has caused nearly 7 million deaths, recognized, and confirmed worldwide (https://www.worldometers.info/coronavirus/?), with high acute and post-acute morbidity [3], making it one of the deadliest in human history, with a devastating impact on national economies worldwide [4].

In the first outbreaks of COVID-19, although 80% were asymptomatic or had mild symptoms, 20% of patients developed severe symptoms, and 5% presented acute respiratory distress syndrome (ARDS), septic shock and accompanied multi-organ organ failure. of a high risk of death. Numerous risk factors have been described that influence the poor outcome of these patients, such as age, sex, high blood pressure, chronic obstructive pulmonary disease, diabetes, obesity, chronic lung and digestive diseases, asthma, chronic heart disease and cancer, D-dimer. greater than 1000) or a high SOFA ( Sequential Organ Failure Assessment Score). It has also been observed that patients with no a priori risk factors, may have a poor outcome [5].

The scientific community immediately proposed strong social containment measures, quickly developed effective vaccines to prevent the appearance of severe clinical forms of COVID-19 [6], and new treatments against all aspects of the disease: antiviral agents, anti-inflammatory agents, antithrombotic therapies, to hypoxemic acute respiratory failure, therapies with anti-SARS-CoV-2 antibodies (neutralizing), modulators of the renin-angiotensin-aldosterone system and vitamins [7], so that social and economic activity has gradually recovered worldwide [4].

However, at the current time, there are some indications that hospital admissions for COVID-19 are on the rise again, so the pandemic seems far from over and future waves of infection are likely [8,9].

These indications update and highlight again the repositioning strategy used since the beginning of the pandemic for the use of safe drugs, approved for another indication, and redirected to improve symptoms and clinical outcomes in patients with COVID-19. Various drugs have been investigated with this strategy and many studies have been published, some of them successful [10].

In this sense, in the first months of the pandemic, on the basis of biological plausibility, we thought that the activation of the vitamin D receptor (VDR) signalling pathway of the vitamin D endocrine system (VDES) could produce beneficial effects in COVID 19, [11], by improving innate antiviral effector mechanisms, facilitating the induction of antimicrobial peptides/autophagy, mitigating the subsequent reactive hyperinflammatory phase of the host, decreasing the cytokine/chemokine storm, modulating the expression of the renin angiotensin system - (RAAS), and neutrophil activity, maintaining the integrity of the pulmonary/intestinal epithelial barrier, stimulating epithelial repair and directly and indirectly reducing the increase in coagulability and prothrombotic tendency associated with a severe course of COVID- 19 and its complications [12]. Available evidence suggests that VDES/VDR stimulation, while maintaining optimal serum 25-hydroxyvitamin D (25(OH)D) status, in patients with SARS-CoV-2 infection may significantly reduce the risk of distress syndrome. acute respiratory syndrome (ARDS) and the development of severe COVID-19 [13].

We decided to use calcifediol, prohormone and cornerstone of the VDES, and substrate for the synthesis of the system's hormone, calcitriol [14]. The poor availability of calcifediol in the general population [15], most marked in patients affected by COVID [16], means that the potential protection that VDR/VDES stimulation confers against various aspects of the disease is lost.

Calcifediol provides pharmacokinetic advantages, which give it a certain functional superiority over native vitamin D3 and even over the hormonal form of VDES, calcitriol, for its use in COVID-19. It is very hydrophilic and, therefore, after oral ingestion, it is absorbed through the portal venous system and does not require hydroxylation at the 25 position, immediately increasing optimal circulating concentrations of 25(OH)D3 [17]. Therefore, even administered orally, it is available at high concentrations within a few hours, and in a stable manner, to be a substrate for calcitriol synthesis in kidney and other target organs in COVID-19 [18].

The clinical trial pilot study and several observational intervention studies using relatively high doses of calcifediol (0.532 µg on day 1 and 0.266 µg on days 3, 7, 14, 21 and 28 decreased the severity of the disease, dramatically reducing the need for ICU admission, severity, and mortality rate [19,20,21] Therefore, using calcifediol at the doses described for rapid correction of 25(OH)D deficiency in all patients in the early stages of COVID-19, in association with the best available therapy, was assessed as a good option. for the treatment of COVID. For this reason, on January 24, 2021, our hospital CALCIFEDIOL was incorporated into the protocol "RECOMMENDATIONS FOR ACTION AND TREATMENT OF THE CORONAVIRUS SARS-CoV-2 DISEASE (COVID-19) version 11.1.

Study Type

Observational

Enrollment (Estimated)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain, 02008
        • Recruiting
        • Complejo Hospitalario Universitario de la Gerencia de Atención Integrada (GAI) de Albacete
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Javier Torres, PhD.
      • Cordoba, Spain, 14004
        • Withdrawn
        • Maimónides Biomedical Research Institute of Córdoba (IMIBIC).

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the GAI Hospital Complex of Albacete, due to COVID-19 [respiratory infection confirmed by radiographic pattern of viral pneumonia and positive polymerase chain reaction (PCR)/antigen for SARS-CoV-2]. Those participants for whom there is not enough information in the files to be able to analyze the study hypotheses will be excluded from the study.

Patients meeting ALL inclusion criteria and NO exclusion criteria will be included in the study.

Description

Inclusion Criteria:

  1. Admitted to the hospital "Complejo Hospitalario de la GAI de Albacete"
  2. Meet the SARS-CoV-2 diagnostic criteria with positive PCR
  3. They have completed at least the first dose of Calcifediol within the first 72 hours after admission, (according to protocol).

Exclusion Criteria:

  1. Patients who do not receive the full first doseof Calcifediol within the first 72 hours.
  2. Patients for whom electronic medical record data cannot be collected.
  3. Patients with other serious intercurrent diseases (eg advanced oncological pathology).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients treated with calcifediol
Patients admitted to the GAI Hospital Complex of Albacete, due to COVID-19 (respiratory infection confirmed by radiographic pattern of viral pneumonia and positive PCR/antigen for SARS-CoV-2) treated with calcifediol
Drug: Calcifediol
Calcifediol added as a treatment to the rest of the prescribed drugs of the protocol
Patients not treated with calcifediol
Patients admitted to the GAI Hospital Complex of Albacete, due to COVID-19 (respiratory infection confirmed by radiographic pattern of viral pneumonia and positive PCR/antigen for SARS-CoV-2) not treated with calcifediol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure mortality by differentiating groups: calcifediol yes/no.
Time Frame: 02/21/2024 to 04/25/2024
Measure mortality by differentiating groups: calcifediol yes/no.
02/21/2024 to 04/25/2024
Measure the need for ICU admission by differentiating the groups calcifediol yes/no.
Time Frame: 02/21/2024 to 04/25/2024
Measure the need for ICU admission by differentiating the groups calcifediol yes/no.
02/21/2024 to 04/25/2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure mortality in relation to baseline 25(OH)D levels
Time Frame: 02/21/2024 to 04/25/2024
Measure mortality in relation to baseline 25(OH)D levels
02/21/2024 to 04/25/2024
To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency
Time Frame: 02/21/2024 to 04/25/2024
To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency
02/21/2024 to 04/25/2024
Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no
Time Frame: 02/21/2024 to 04/25/2024
Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no
02/21/2024 to 04/25/2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Complejo Hospitalario Universitario de Albacete

Investigators

  • Study Chair: Javier Torres, PhD, Complejo Hospitalario Universitario de Albacete. Albacete. Spain
  • Study Director: Jose M Quesada, MD, Maimónides Biomedical Research Institute of Córdoba (IMIBIC). Córdoba. Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 21, 2024

Primary Completion (Estimated)

March 21, 2024

Study Completion (Estimated)

April 25, 2024

Study Registration Dates

First Submitted

February 25, 2024

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Estimated)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021 36 (EOm)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized information collected from patients will be shared publicly upon request. All information related to variables or results included in the study will be shared.

IPD Sharing Time Frame

Data will be made available in the following months after all results will have been published.

IPD Sharing Access Criteria

All data requests will be reviewed by the principal investigator of the project. Data will be shared upon reasonable request to be examined or reviewed. It will not be permitted to carry out any other kind of study (including statistical) by people other than the researchers of the main study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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