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

NCT04366908 | Completed Phase 2 DMC

• 1 other identifier: COVIDIOL
• Study Type: interventional
• Target: 517
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV 2; COVID19; SARS (Severe Acute Respiratory Syndrome); Cytokine Release Syndrome; Cytokine Storm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Time from onset of symptoms to discharge of patients in conventional hospitalization

  At day 28.

• ICU - Time until admission

  At day 28.

• ICU - Time mechanical ventilation is removed

  At day 28.

• Evaluation of the inflammatory markers related with the disease

  At day 28.

• Vitamin D metabolites

  At day 28.

Study Arms (2)

Control - best available therapy

ACTIVE COMPARATOR

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

Treatment

EXPERIMENTAL

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

Interventions

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

Treatment

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).

Control - best available therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages
• Intolerance or allergy to Calcifediol or its components
• Pregnancy

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead
• Junta de Andalucia: collaborator
• Dynamic Solutions: collaborator
• Faes Farma, S.A.: collaborator

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14001, Spain

Location

Related Publications (1)

• 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.

  PMID: 34029377 DERIVED

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Cytokine Release Syndrome

Interventions

glycine N-choloyltransferase; Calcifediol

Condition Hierarchy (Ancestors)

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• José López Miranda, MD

  Hospital Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 29, 2020
• Study Start: May 7, 2020
• Primary Completion: April 19, 2022
• Study Completion: April 19, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Since the end publication of the results.
• Access Criteria: Contact uicec@imibic.org

Locations

ES (1)