Calcifediol in the Treatment of COVID 19

NCT05819918 | Completed

• 1 other identifier: TD-CCRC-21
• Study Type: observational
• Target: 728
• Locations: 1 country
• Sites: 1

Brief Summary

Patients hospitalized with COVID-19 treated with calcifediol during the first outbreaks of the pandemic (until the first vaccinations) are compared with the aim of determining the therapeutic, clinical, functional, and biochemical variables that modify the response (admission to ICU or death) to calcifediol during hospitalization for COVID 19

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

• Need for ICU admission

  Measure the need for ICU admission by differentiating the groups calcifediol yes/no; corticosteroids yes/no.

  from hospitalization till discharge /death

• Mortality

  Measure mortality by differentiating groups: calcifediol yes/no; corticosteroids yes/no.

  from hospitalization till discharge /death

• Composite variable poor prognosis, (ICU&death)

  Measure the composite variable poor prognosis, (ICU\&death) by differentiating the groups calcifediol yes/no; corticosteroids yes/no.

  from hospitalization till discharge /death

Secondary Outcomes (2)

• clinical variables that calcifediol response

  from hospitalization till discharge /death

• drug modifying calcifediol response

  from hospitalization till discharge /death

Study Arms (2)

Calcifediol

Drug: Calcifediol

Best therapy available

Drug: Best available therapy

Interventions

Calcifediol DRUG

Subjects hospitalized with COVID-19 treated with calcifediol

Calcifediol

Best available therapy DRUG

Subjects hospitalized with COVID-19 treated with Azithromycin, hydroxychloroquine, corticoids and others authorized treatments.

Best therapy available

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients requiring hospital admission due to respiratory infection confirmed by SARS-CoV-2 (radiographic pattern of viral pneumonia and positive PCR for SARS-CoV-2) with a CURB65 severity scale (recommending hospital admission in case of a total score \> 1). Patients meeting ALL inclusion criteria and NO exclusion criteria will be included in the study.

You may qualify if:

• Age ≥ 18 and \< 90 years.
• Diagnosis confirmed by positive polymerase chain reaction (PCR) for COVID-19.
• Radiological image compatible with pulmonary involvement by COVID-19.
• Admission to "Reina Sofia university Hospital (HURS)" Pneumology Department.

You may not qualify if:

• Patients for whom electronic medical record data cannot be collected.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofia

Córdoba, Córdoba, 14004, Spain

Location

Related Publications (22)

• Wiersinga WJ, Rhodes A, Cheng AC, Peacock SJ, Prescott HC. Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review. JAMA. 2020 Aug 25;324(8):782-793. doi: 10.1001/jama.2020.12839.

  PMID: 32648899 BACKGROUND

• Grana C, Ghosn L, Evrenoglou T, Jarde A, Minozzi S, Bergman H, Buckley BS, Probyn K, Villanueva G, Henschke N, Bonnet H, Assi R, Menon S, Marti M, Devane D, Mallon P, Lelievre JD, Askie LM, Kredo T, Ferrand G, Davidson M, Riveros C, Tovey D, Meerpohl JJ, Grasselli G, Rada G, Hrobjartsson A, Ravaud P, Chaimani A, Boutron I. Efficacy and safety of COVID-19 vaccines. Cochrane Database Syst Rev. 2022 Dec 7;12(12):CD015477. doi: 10.1002/14651858.CD015477.

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  PMID: 35299987 BACKGROUND

• Jayk Bernal A, Gomes da Silva MM, Musungaie DB, Kovalchuk E, Gonzalez A, Delos Reyes V, Martin-Quiros A, Caraco Y, Williams-Diaz A, Brown ML, Du J, Pedley A, Assaid C, Strizki J, Grobler JA, Shamsuddin HH, Tipping R, Wan H, Paschke A, Butterton JR, Johnson MG, De Anda C; MOVe-OUT Study Group. Molnupiravir for Oral Treatment of Covid-19 in Nonhospitalized Patients. N Engl J Med. 2022 Feb 10;386(6):509-520. doi: 10.1056/NEJMoa2116044. Epub 2021 Dec 16.

  PMID: 34914868 BACKGROUND

• Reis S, Metzendorf MI, Kuehn R, Popp M, Gagyor I, Kranke P, Meybohm P, Skoetz N, Weibel S. Nirmatrelvir combined with ritonavir for preventing and treating COVID-19. Cochrane Database Syst Rev. 2022 Sep 20;9(9):CD015395. doi: 10.1002/14651858.CD015395.pub2.

  PMID: 36126225 BACKGROUND

• Quesada-Gomez JM, Entrenas-Castillo M, Bouillon R. Vitamin D receptor stimulation to reduce acute respiratory distress syndrome (ARDS) in patients with coronavirus SARS-CoV-2 infections: Revised Ms SBMB 2020_166. J Steroid Biochem Mol Biol. 2020 Sep;202:105719. doi: 10.1016/j.jsbmb.2020.105719. Epub 2020 Jun 11.

  PMID: 32535032 BACKGROUND

• Entrenas Castillo M, Entrenas Costa LM, Vaquero Barrios JM, Alcala Diaz JF, Lopez Miranda J, Bouillon R, Quesada Gomez JM. "Effect of calcifediol treatment and best available therapy versus best available therapy on intensive care unit admission and mortality among patients hospitalized for COVID-19: A pilot randomized clinical study". J Steroid Biochem Mol Biol. 2020 Oct;203:105751. doi: 10.1016/j.jsbmb.2020.105751. Epub 2020 Aug 29.

  PMID: 32871238 BACKGROUND

• Nogues X, Ovejero D, Pineda-Moncusi M, Bouillon R, Arenas D, Pascual J, Ribes A, Guerri-Fernandez R, Villar-Garcia J, Rial A, Gimenez-Argente C, Cos ML, Rodriguez-Morera J, Campodarve I, Quesada-Gomez JM, Garcia-Giralt N. Calcifediol Treatment and COVID-19-Related Outcomes. J Clin Endocrinol Metab. 2021 Sep 27;106(10):e4017-e4027. doi: 10.1210/clinem/dgab405.

  PMID: 34097036 BACKGROUND

• Alcala-Diaz JF, Limia-Perez L, Gomez-Huelgas R, Martin-Escalante MD, Cortes-Rodriguez B, Zambrana-Garcia JL, Entrenas-Castillo M, Perez-Caballero AI, Lopez-Carmona MD, Garcia-Alegria J, Lozano Rodriguez-Mancheno A, Arenas-de Larriva MDS, Perez-Belmonte LM, Jungreis I, Bouillon R, Quesada-Gomez JM, Lopez-Miranda J. Calcifediol Treatment and Hospital Mortality Due to COVID-19: A Cohort Study. Nutrients. 2021 May 21;13(6):1760. doi: 10.3390/nu13061760.

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• Loucera C, Pena-Chilet M, Esteban-Medina M, Munoyerro-Muniz D, Villegas R, Lopez-Miranda J, Rodriguez-Bano J, Tunez I, Bouillon R, Dopazo J, Quesada Gomez JM. Real world evidence of calcifediol or vitamin D prescription and mortality rate of COVID-19 in a retrospective cohort of hospitalized Andalusian patients. Sci Rep. 2021 Dec 3;11(1):23380. doi: 10.1038/s41598-021-02701-5.

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• Arabi YM, Mandourah Y, Al-Hameed F, Sindi AA, Almekhlafi GA, Hussein MA, Jose J, Pinto R, Al-Omari A, Kharaba A, Almotairi A, Al Khatib K, Alraddadi B, Shalhoub S, Abdulmomen A, Qushmaq I, Mady A, Solaiman O, Al-Aithan AM, Al-Raddadi R, Ragab A, Balkhy HH, Al Harthy A, Deeb AM, Al Mutairi H, Al-Dawood A, Merson L, Hayden FG, Fowler RA; Saudi Critical Care Trial Group. Corticosteroid Therapy for Critically Ill Patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med. 2018 Mar 15;197(6):757-767. doi: 10.1164/rccm.201706-1172OC.

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• RECOVERY Collaborative Group; Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients with Covid-19. N Engl J Med. 2021 Feb 25;384(8):693-704. doi: 10.1056/NEJMoa2021436. Epub 2020 Jul 17.

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• Sarzani R, Spannella F, Giulietti F, Di Pentima C, Giordano P, Giacometti A. Possible harm from glucocorticoid drugs misuse in the early phase of SARS-CoV-2 infection: a narrative review of the evidence. Intern Emerg Med. 2022 Mar;17(2):329-338. doi: 10.1007/s11739-021-02860-3. Epub 2021 Oct 31.

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• Update to living WHO guideline on drugs for covid-19. BMJ. 2021 Sep 23;374:n2219. doi: 10.1136/bmj.n2219. No abstract available.

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• Blazquez-Cabrera JA, Torres-Hernandez J, Bouillon R, Casado-Diaz A, Quesada-Gomez JM, Navarro-Casado L. ALBACOVIDIOL Study: Effect of Calcifediol Treatment on Mortality in Patients Hospitalized for COVID-19: A Retrospective Analysis. Nutrients. 2025 Jun 10;17(12):1968. doi: 10.3390/nu17121968.

  PMID: 40573079 DERIVED

• Entrenas-Castillo M, Entrenas-Costa LM, Pata MP, Gamez BJ, Munoz-Corroto C, Gomez-Rebollo C, Mira-Padilla E, Bouillon R, Quesada-Gomez JM. Latent Class Analysis Reveals, in patient profiles, COVID-19-related better prognosis by calcifediol treatment than glucocorticoids. J Steroid Biochem Mol Biol. 2025 Jan;245:106609. doi: 10.1016/j.jsbmb.2024.106609. Epub 2024 Aug 31.

  PMID: 39218235 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Luis M Entrenas Costa, MD

  Hospital Universitario Reina Sofia de Cordoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 19, 2023
• Study Start: April 1, 2022
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

ES (1)