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

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ClinicalTrials.gov Identifier: NCT04366908
Recruitment Status : Not yet recruiting
First Posted : April 29, 2020
Last Update Posted : April 30, 2020
Sponsor:
Collaborators:
Junta de Andalucía - Consejería de Salud y Familias
Dynamic Solutions
FAES Farma
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
SARS-CoV 2 COVID19 SARS (Severe Acute Respiratory Syndrome) Cytokine Release Syndrome Cytokine Storm Drug: BAT + Calcifediol Drug: BAT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)
Estimated Study Start Date : April 28, 2020
Estimated Primary Completion Date : July 28, 2020
Estimated Study Completion Date : August 28, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Calcifediol

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





Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 and < 90 years
  • PCR confirmed diagnosis of COVID-19
  • Radiological image compatible with inflammatory pleuropulmonary exudate
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366908


Contacts
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Contact: José Manuel Quesada Gómez, MD 0034671596070 md1qugoj@uco.es
Contact: Antonio Luque, MsC 0034671596070 uicec@imibic.org

Sponsors and Collaborators
Maimónides Biomedical Research Institute of Córdoba
Junta de Andalucía - Consejería de Salud y Familias
Dynamic Solutions
FAES Farma
Investigators
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Principal Investigator: José López Miranda, MD Hospital Universitario Reina Sofía
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Responsible Party: Maimónides Biomedical Research Institute of Córdoba
ClinicalTrials.gov Identifier: NCT04366908    
Other Study ID Numbers: COVIDIOL
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the information will be published and accessible. It will be also available on demand.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Since the end publication of the results.
Access Criteria: Contact uicec@imibic.org

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Severe Acute Respiratory Syndrome
Coronavirus Infections
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents