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Completed

NCT Number: NCT04366908

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

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.

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Key information

Conditions

SARS-CoV 2 COVID-19 Coronaviridae Infections Coronavirus Infections Covid19 Cytokine Release Syndrome Cytokine Storm Infections Inflammation Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS (Severe Acute Respiratory Syndrome) Severe Acute Respiratory Syndrome Shock Systemic Inflammatory Response Syndrome Virus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitario Reina Sofía

Córdoba, 14001, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAT + Calcifediol

Drug

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

Drug

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 outcomes

  1. Admission to Intensive Care Unit

    Time frame: At day 28.

    Proportion of subjects who enter the Intensive Care Unit

  2. Death

    Time frame: At day 28.

    Proportion of subjects who die.

Secondary outcomes

  1. Time from onset of symptoms to discharge of patients in conventional hospitalization

    Time frame: At day 28.

    Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.

  2. ICU - Time until admission

    Time frame: 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

  3. ICU - Time mechanical ventilation is removed

    Time frame: 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.

  4. Evaluation of the inflammatory markers related with the disease

    Time frame: 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.

  5. Vitamin D metabolites

    Time frame: At day 28.

    Evaluation of the Vitamin D metabolites.

  6. Evolution in SatO2

    Time frame: At day 28.

    Compare the evolution in SatO2

  7. Evolution in the Sat O2/FiO2 ratio.

    Time frame: At day 28.

    Compare the evolution in the Sat O2/FiO2 ratio

  8. Evolution in the degree of dyspnea

    Time frame: At day 28.

    Compare the evolution in the degree of dyspnea using the analog Borg scale

  9. Evolution of the improvement of radiological findings by simple radiology

    Time frame: 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

  10. Incidence of adverse events

    Time frame: At day 28.

    Incidence of adverse events related to medication and its administration.

  11. Appearance of hemorrhagic or thrombotic phenomena

    Time frame: At day 28.

    Incidence in the appearance of hemorrhagic or thrombotic phenomena.

Sponsors and collaborators

Lead sponsor

Maimónides Biomedical Research Institute of Córdoba

Other

Collaborators

  • Dynamic Solutions
  • Faes Farma, S.A.
  • Junta de Andalucia

Registry information

Official study title

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

Acronym: COVIDIOL

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2020
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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