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

• ClinicalTrials.gov Identifier: NCT04366908
• Recruitment Status: Completed
• First Posted: April 29, 2020
• Last Update Posted: March 3, 2023
• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Junta de Andalucía - Consejería de Salud y Familias, Spain; Dynamic Solutions; Faes Farma, S.A.
• Information provided by (Responsible Party): Maimónides Biomedical Research Institute of Córdoba

Study Description

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 517 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)
• Actual Study Start Date: May 7, 2020
• Actual Primary Completion Date: April 19, 2022
• Actual Study Completion Date: April 19, 2022

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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. 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

Contacts and Locations

Locations

Spain

Hospital Universitario Reina Sofía

Cordoba, Spain, 14001

Sponsors and Collaborators

Maimónides Biomedical Research Institute of Córdoba

Junta de Andalucía - Consejería de Salud y Familias, Spain

Dynamic Solutions

Faes Farma, S.A.

Investigators

• Principal Investigator: José López Miranda, MD; Hospital Universitario Reina Sofía

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Maimónides Biomedical Research Institute of Córdoba
• ClinicalTrials.gov Identifier: NCT04366908
• Other Study ID Numbers: COVIDIOL
• First Posted: April 29, 2020
• Last Update Posted: March 3, 2023
• Last Verified: March 2023

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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

COVID-19; Severe Acute Respiratory Syndrome; Syndrome; Cytokine Release Syndrome; Disease; Pathologic Processes; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Calcifediol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents