Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).

NCT06279910 | Completed

• 1 other identifier: 2021 36 (EOm)
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Descriptive, retrospective, observational, anonymous, study to evaluate the potential effect of incorporating calcifediol into the therapeutic protocol of patients hospitalized for COVID-19 on mortality and other outcome variables, such as admission to the Intensive Care Unit (ICU), to "Complejo Hospitalario Universitario de Albacete" (CHUA). Albacete (Spain)", based on the files of the MXXI medical records, Information System of the Laboratory (ISL) and Pharmacy.

Conditions

SARS-CoV 2 Pneumonia

Keywords

Calcifediol; Cathelicidin peptide; Corticoids; COVID-19; Cytokine storm; Multiorgan failure; Pneumonia; Respiratory distress syndrome (ARDS); Respiratory failure; SARS-CoV-2; Vitamin D; Vitamin D endocrine system; VDR Vitamin D

Outcome Measures

Primary Outcomes (2)

• Measure mortality by differentiating groups: calcifediol yes/no.

  Measure mortality by differentiating groups: calcifediol yes/no.

  02/21/2024 to 04/25/2024

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

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

  02/21/2024 to 04/25/2024

Secondary Outcomes (3)

• Measure mortality in relation to baseline 25(OH)D levels

  02/21/2024 to 04/25/2024

• To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency

  02/21/2024 to 04/25/2024

• Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no

  02/21/2024 to 04/25/2024

Study Arms (2)

Patients treated with calcifediol

Patients admitted to the CHUA, due to COVID-19 \[respiratory infection confirmed by radiographic pattern of viral pneumonia and positive polymerase chain reaction (PCR)/antigen for SARS-CoV-2\] treated with calcifediol

Drug: Calcifediol

Patients not treated with calcifediol

Patients admitted to the CHUA, due to COVID-19 (respiratory infection confirmed by radiographic pattern of viral pneumonia and positive PCR/antigen for SARS-CoV-2) not treated with calcifediol

Interventions

Calcifediol DRUG

Calcifediol added as a treatment to the rest of the prescribed drugs of the protocol

Patients treated with calcifediol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the CHUA, due to COVID-19 \[respiratory infection confirmed by radiographic pattern of viral pneumonia and positive PCR/antigen for SARS-CoV-2\]. Those participants for whom there is not enough information in the files to be able to analyze the study hypotheses will be excluded from the study. Patients meeting ALL inclusion criteria and NO exclusion criteria will be included in the study.

You may qualify if:

• Admitted to the hospital CHUA
• Meet the SARS-CoV-2 diagnostic criteria with positive PCR
• They have completed at least the first dose of Calcifediol within the first 72 hours after admission, (according to protocol).

You may not qualify if:

• Patients who do not receive the full first dose of Calcifediol within the first 72 hours.
• Patients for whom electronic medical record data cannot be collected.
• Patients with other serious intercurrent diseases (eg advanced oncological pathology).

Sponsors & Collaborators

• Complejo Hospitalario Universitario de Albacete: lead

Study Sites (1)

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, 02008, Spain

Location

Related Publications (20)

• Ranabhat CL, Jakovljevic M, Kim CB, Simkhada P. COVID-19 Pandemic: An Opportunity for Universal Health Coverage. Front Public Health. 2021 Jul 29;9:673542. doi: 10.3389/fpubh.2021.673542. eCollection 2021. No abstract available.

  PMID: 34395361 BACKGROUND

• Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

  PMID: 31978945 BACKGROUND

• Bowe B, Xie Y, Al-Aly Z. Postacute sequelae of COVID-19 at 2 years. Nat Med. 2023 Sep;29(9):2347-2357. doi: 10.1038/s41591-023-02521-2. Epub 2023 Aug 21.

  PMID: 37605079 BACKGROUND

• Giliberto Capano, Michael Howlett, Darryl S L Jarvis, M Ramesh, Long-term policy impacts of the coronavirus: normalization, adaptation, and acceleration in the post-COVID state, Policy and Society, 2022; 41 (1): 1-12, doi: 10.1093/polsoc/puab018

  BACKGROUND

• 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

• Pritchard E, Matthews PC, Stoesser N, Eyre DW, Gethings O, Vihta KD, Jones J, House T, VanSteenHouse H, Bell I, Bell JI, Newton JN, Farrar J, Diamond I, Rourke E, Studley R, Crook D, Peto TEA, Walker AS, Pouwels KB. Impact of vaccination on new SARS-CoV-2 infections in the United Kingdom. Nat Med. 2021 Aug;27(8):1370-1378. doi: 10.1038/s41591-021-01410-w. Epub 2021 Jun 9.

  PMID: 34108716 BACKGROUND

• Murakami N, Hayden R, Hills T, Al-Samkari H, Casey J, Del Sorbo L, Lawler PR, Sise ME, Leaf DE. Therapeutic advances in COVID-19. Nat Rev Nephrol. 2023 Jan;19(1):38-52. doi: 10.1038/s41581-022-00642-4. Epub 2022 Oct 17.

  PMID: 36253508 BACKGROUND

• El-Sadr WM, Vasan A, El-Mohandes A. Facing the New Covid-19 Reality. N Engl J Med. 2023 Feb 2;388(5):385-387. doi: 10.1056/NEJMp2213920. Epub 2023 Jan 28. No abstract available.

  PMID: 36724378 BACKGROUND

• The Lancet. The COVID-19 pandemic in 2023: far from over. Lancet. 2023 Jan 14;401(10371):79. doi: 10.1016/S0140-6736(23)00050-8. No abstract available.

  PMID: 36641201 BACKGROUND

• Kato Y, Nishiyama K, Nishimura A, Noda T, Okabe K, Kusakabe T, Kanda Y, Nishida M. Drug repurposing for the treatment of COVID-19. J Pharmacol Sci. 2022 Jul;149(3):108-114. doi: 10.1016/j.jphs.2022.04.007. Epub 2022 Apr 25.

  PMID: 35641023 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

• Quesada-Gomez JM, Lopez-Miranda J, Entrenas-Castillo M, Casado-Diaz A, Nogues Y Solans X, Mansur JL, Bouillon R. Vitamin D Endocrine System and COVID-19: Treatment with Calcifediol. Nutrients. 2022 Jun 29;14(13):2716. doi: 10.3390/nu14132716.

  PMID: 35807895 BACKGROUND

• Quesada-Gomez JM, Bouillon R. Calcifediol Cornerstone of the Vitamin D Endocrine System. Nutrients. 2023 May 12;15(10):2290. doi: 10.3390/nu15102290.

  PMID: 37242173 BACKGROUND

• Lips P, Cashman KD, Lamberg-Allardt C, Bischoff-Ferrari HA, Obermayer-Pietsch B, Bianchi ML, Stepan J, El-Hajj Fuleihan G, Bouillon R. Current vitamin D status in European and Middle East countries and strategies to prevent vitamin D deficiency: a position statement of the European Calcified Tissue Society. Eur J Endocrinol. 2019 Apr;180(4):P23-P54. doi: 10.1530/EJE-18-0736.

  PMID: 30721133 BACKGROUND

• Wang Z, Joshi A, Leopold K, Jackson S, Christensen S, Nayfeh T, Mohammed K, Creo A, Tebben P, Kumar S. Association of vitamin D deficiency with COVID-19 infection severity: Systematic review and meta-analysis. Clin Endocrinol (Oxf). 2022 Mar;96(3):281-287. doi: 10.1111/cen.14540. Epub 2021 Jul 12.

  PMID: 34160843 BACKGROUND

• Bouillon R, Quesada-Gomez JM. Vitamin D Endocrine System and COVID-19. JBMR Plus. 2021 Nov 17;5(12):e10576. doi: 10.1002/jbm4.10576. eCollection 2021 Dec.

  PMID: 34950831 BACKGROUND

• Bouillon R, Quesada Gomez JM. Comparison of calcifediol with vitamin D for prevention or cure of vitamin D deficiency. J Steroid Biochem Mol Biol. 2023 Apr;228:106248. doi: 10.1016/j.jsbmb.2023.106248. Epub 2023 Jan 13.

  PMID: 36646151 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.

  PMID: 34064175 BACKGROUND

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome; Multiple Organ Failure; Pneumonia; Respiratory Distress Syndrome; Respiratory Insufficiency

Interventions

Calcifediol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; 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; Respiration Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Javier Torres, PhD

  Complejo Hospitalario Universitario de Albacete. Albacete. Spain

  STUDY CHAIR

• Jose M Quesada, MD

  Maimónides Biomedical Research Institute of Córdoba (IMIBIC). Córdoba. Spain

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: February 28, 2024
• Study Start: February 21, 2024
• Primary Completion: March 21, 2024
• Study Completion: April 25, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available in the following months after all results will have been published.
• Access Criteria: All data requests will be reviewed by the principal investigator of the project. Data will be shared upon reasonable request to be examined or reviewed. It will not be permitted to carry out any other kind of study (including statistical) by people other than the researchers of the main study.

Locations

ES (1)