SARS-CoV 2 PneumoniaCOVIDIOLNCT06279910
Calcifediol in the Treatment of SARS-CoV-2 Disease (COVID-19).
An observational study of SARS-CoV 2 Pneumonia, run by Complejo Hospitalario Universitario de Albacete at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV 2 Pneumonia
- What is being tested?
- Calcifediol
- How many people
- 230 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2024to 25 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, 02008
About this study
Official title: Inclusion of Calcifediol in the Hospital Therapeutic Protocol for Treatment of SARS-CoV-2 Disease (COVID-19). Mortality Analysis. Retrospective Study.
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.
Read the detailed description
The coronavirus disease-19 (COVID-19) pandemic, caused by the severe acute respiratory syndrome β-coronavirus (SARS-CoV-2), is one of the greatest challenges facing modern medicine and public health systems worldwide. Since its appearance in December 2019, it has caused nearly 7 million deaths, recognized, and confirmed worldwide, with high acute and post-acute morbidity, making it one of the deadliest in human history, with a devastating impact on national economies worldwide.
In the first outbreaks of COVID-19, although 80% were asymptomatic or had mild symptoms, 20% of patients developed severe symptoms, and 5% presented acute respiratory distress syndrome (ARDS), septic shock and accompanied multi-organ organ failure, with a high risk of death. Numerous risk factors have been described that influence the poor outcome of these patients, such as age, sex, high blood pressure, chronic obstructive pulmonary disease, diabetes, obesity, chronic lung and digestive diseases, asthma, chronic heart disease, cancer, D-dimer greater than 1000, or a high SOFA (Sequential Organ Failure Assessment Score). It has also been observed that patients with no a priori risk factors may have a poor outcome.
The scientific community immediately proposed strong social containment measures, quickly developed effective vaccines to prevent the appearance of severe clinical forms of COVID-19, and developed new treatments against all aspects of the disease: antiviral agents, anti-inflammatory agents, antithrombotic therapies, therapies against hypoxemic acute respiratory failure, therapies with anti-SARS-CoV-2 antibodies (neutralizing), modulators of the renin-angiotensin-aldosterone system and vitamins, so that social and economic activity has gradually recovered worldwide.
However, at the current time, there are some indications that hospital admissions for COVID-19 are on the rise again, so the pandemic seems far from over and future waves of infection are likely. These indications update and highlight again the repositioning strategy used since the beginning of the pandemic for the use of safe drugs, approved for another indication, and redirected to improve symptoms and clinical outcomes in patients with COVID-19. Various drugs have been investigated under this strategy and many studies have been published, some of them successful.
In this sense, during the first months of the pandemic, on the basis of biological plausibility, the investigators thought that the activation of the vitamin D receptor (VDR) signaling pathway of the vitamin D endocrine system (VDES) could produce beneficial effects in COVID-19. These effects were achieved by improving innate antiviral effector mechanisms, facilitating the induction of antimicrobial peptides/autophagy, mitigating the subsequent reactive hyperinflammatory phase of the host, decreasing the cytokine/chemokine storm, modulating the expression of the renin angiotensin system (RAAS) and neutrophil activity, maintaining the integrity of the pulmonary/intestinal epithelial barrier, stimulating epithelial repair and directly and indirectly reducing the increase in coagulability and prothrombotic tendency associated with a severe course of COVID-19 and its complications. Available evidence suggests that VDES/VDR stimulation, while maintaining optimal serum 25-hydroxyvitamin D [(25(OH)D)] status, in patients with SARS-CoV-2 infection may significantly reduce the risk of distress syndrome, acute respiratory distress syndrome (ARDS) and the development of severe COVID-19.
The investigators decided to use calcifediol, which is a prohormone (and cornerstone of the VDES) and substrate for the synthesis of the system's hormone, calcitriol. The poor availability of calcifediol described in the general population, most marked in patients affected by COVID, means that the potential protection that VDR/VDES stimulation confers against various aspects of the disease is lost.
Calcifediol provides pharmacokinetic advantages, which give it a certain functional superiority over native vitamin D3 and even over the hormonal form of VDES, calcitriol, for its use in COVID-19. It is very hydrophilic and, therefore, after oral ingestion, it is absorbed through the portal venous system and does not require hydroxylation at the 25 position, immediately increasing optimal circulating concentrations of 25(OH)D3. Therefore, even if administered orally, it is available at high concentrations within a few hours, and in a stable manner, to be a substrate for calcitriol synthesis at the kidney and other target organs in COVID-19.
The clinical trial pilot study and several observational intervention studies using relatively high doses of calcifediol (0.532 µg on day 1 and 0.266 µg on days 3, 7, 14, 21 and 28) decreased the severity of the disease, dramatically reducing the need for ICU admission, severity, and mortality rate.
Therefore, using calcifediol at the doses described for rapid correction of 25(OH)D deficiency in all patients in the early stages of COVID-19, in association with the best available therapy, was assessed as a good option for the treatment of COVID-19. For this reason, on January 24, 2021, the CHUA incorporated calcifediol into the protocol "Recommendations for action and treatment of the coronavirus SARS-CoV-2 disease" (COVID-19) version 11.1".
- Conditions
- SARS-CoV 2 Pneumonia
- Being tested
- Calcifediol
- 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
- Medical subject headings
- COVID-19, Cytokine Release Syndrome, Multiple Organ Failure, Pneumonia, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalcifediolDrug
Calcifediol added as a treatment to the rest of the prescribed drugs of the protocol
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure mortality by differentiating groups: calcifediol yes/no.
Measure mortality by differentiating groups: calcifediol yes/no.
Measured: 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.
Measured: 02/21/2024 to 04/25/2024
Secondary outcomes (3)
Measure mortality in relation to baseline 25(OH)D levels
Measure mortality in relation to baseline 25(OH)D levels
Measured: 02/21/2024 to 04/25/2024
To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency
To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency
Measured: 02/21/2024 to 04/25/2024
Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no
Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no
Measured: 02/21/2024 to 04/25/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start21 Feb 2024
- Primary completion21 Mar 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Universitario de Albacete
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Torres, PhD, Study chair, Complejo Hospitalario Universitario de Albacete. Albacete. SpainJose M Quesada, MD, Study director, Maimónides Biomedical Research Institute of Córdoba (IMIBIC). Córdoba. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279910
- Sponsor's protocol ID
- 2021 36 (EOm)
- Acronym
- COVIDIOL
- Status last verified
- Jun 2025
- First submitted
- 25 Feb 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized information collected from patients will be shared publicly upon request. All information related to variables or results included in the study will be shared.
Publications
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.
PubMed 34395361Zhu 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.
PubMed 31978945Bowe 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.
PubMed 37605079Giliberto 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
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.
PubMed 32648899Pritchard 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.
PubMed 34108716Murakami 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.
PubMed 36253508El-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.
PubMed 36724378The 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.
PubMed 36641201Kato 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.
PubMed 35641023Quesada-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.
PubMed 32535032Quesada-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.
PubMed 35807895Quesada-Gomez JM, Bouillon R. Calcifediol Cornerstone of the Vitamin D Endocrine System. Nutrients. 2023 May 12;15(10):2290. doi: 10.3390/nu15102290.
PubMed 37242173Lips 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.
PubMed 30721133Wang 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.
PubMed 34160843
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inclusion of Calcifediol in the Hospital Therapeutic Protocol for Treatment of SARS-CoV-2 Disease (COVID-19). Mortality Analysis. Retrospective Study.
- ClinicalTrials.gov ID
- NCT06279910
- Acronym / sponsor ID
- COVIDIOL / 2021 36 (EOm)
- Conditions
- SARS-CoV 2 Pneumonia
- Keywords
- Calcifediol, Cathelicidin peptide, Corticoids, COVID-19, Cytokine storm, Multiorgan failure, Pneumonia, Respiratory distress syndrome (ARDS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Complejo Hospitalario Universitario de AlbaceteUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The coronavirus disease-19 (COVID-19) pandemic, caused by the severe acute respiratory syndrome β-coronavirus (SARS-CoV-2), is one of the greatest challenges facing modern medicine and public health systems worldwide. Since its appearance in December 2019, it has caused nearly 7 million deaths, recognized, and confirmed worldwide, with high acute and post-acute morbidity, making it one of the deadliest in human history, with a devastating impact on national economies worldwide.
In the first outbreaks of COVID-19, although 80% were asymptomatic or had mild symptoms, 20% of patients developed severe symptoms, and 5% presented acute respiratory distress syndrome (ARDS), septic shock and accompanied multi-organ organ failure, with a high risk of death. Numerous risk factors have been described that influence the poor outcome of these patients, such as age, sex, high blood pressure, chronic obstructive pulmonary disease, diabetes, obesity, chronic lung and digestive diseases, asthma, chronic heart disease, cancer, D-dimer greater than 1000, or a high SOFA (Sequential Organ Failure Assessment Score). It has also been observed that patients with no a priori risk factors may have a poor outcome.
The scientific community immediately proposed strong social containment measures, quickly developed effective vaccines to prevent the appearance of severe clinical forms of COVID-19, and developed new treatments against all aspects of the disease: antiviral agents, anti-inflammatory agents, antithrombotic therapies, therapies against hypoxemic acute respiratory failure, therapies with anti-SARS-CoV-2 antibodies (neutralizing), modulators of the renin-angiotensin-aldosterone system and vitamins, so that social and economic activity has gradually recovered worldwide.
However, at the current time, there are some indications that hospital admissions for COVID-19 are on the rise again, so the pandemic seems far from over and future waves of infection are likely. These indications update and highlight again the repositioning strategy used since the beginning of the pandemic for the use of safe drugs, approved for another indication, and redirected to improve symptoms and clinical outcomes in patients with COVID-19. Various drugs have been investigated under this strategy and many studies have been published, some of them successful.
In this sense, during the first months of the pandemic, on the basis of biological plausibility, the investigators thought that the activation of the vitamin D receptor (VDR) signaling pathway of the vitamin D endocrine system (VDES) could produce beneficial effects in COVID-19. These effects were achieved by improving innate antiviral effector mechanisms, facilitating the induction of antimicrobial peptides/autophagy, mitigating the subsequent reactive hyperinflammatory phase of the host, decreasing the cytokine/chemokine storm, modulating the expression of the renin angiotensin system (RAAS) and neutrophil activity, maintaining the integrity of the pulmonary/intestinal epithelial barrier, stimulating epithelial repair and directly and indirectly reducing the increase in coagulability and prothrombotic tendency associated with a severe course of COVID-19 and its complications. Available evidence suggests that VDES/VDR stimulation, while maintaining optimal serum 25-hydroxyvitamin D [(25(OH)D)] status, in patients with SARS-CoV-2 infection may significantly reduce the risk of distress syndrome, acute respiratory distress syndrome (ARDS) and the development of severe COVID-19.
The investigators decided to use calcifediol, which is a prohormone (and cornerstone of the VDES) and substrate for the synthesis of the system's hormone, calcitriol. The poor availability of calcifediol described in the general population, most marked in patients affected by COVID, means that the potential protection that VDR/VDES stimulation confers against various aspects of the disease is lost.
Calcifediol provides pharmacokinetic advantages, which give it a certain functional superiority over native vitamin D3 and even over the hormonal form of VDES, calcitriol, for its use in COVID-19. It is very hydrophilic and, therefore, after oral ingestion, it is absorbed through the portal venous system and does not require hydroxylation at the 25 position, immediately increasing optimal circulating concentrations of 25(OH)D3. Therefore, even if administered orally, it is available at high concentrations within a few hours, and in a stable manner, to be a substrate for calcitriol synthesis at the kidney and other target organs in COVID-19.
The clinical trial pilot study and several observational intervention studies using relatively high doses of calcifediol (0.532 µg on day 1 and 0.266 µg on days 3, 7, 14, 21 and 28) decreased the severity of the disease, dramatically reducing the need for ICU admission, severity, and mortality rate.
Therefore, using calcifediol at the doses described for rapid correction of 25(OH)D deficiency in all patients in the early stages of COVID-19, in association with the best available therapy, was assessed as a good option for the treatment of COVID-19. For this reason, on January 24, 2021, the CHUA incorporated calcifediol into the protocol "Recommendations for action and treatment of the coronavirus SARS-CoV-2 disease" (COVID-19) version 11.1".
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with calcifediol | – | Drug: CalcifediolPatients 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 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalcifediolCalcifediol added as a treatment to the rest of the prescribed drugs of the protocol | Drug | Patients treated with calcifediol |
Primary outcome
Measure mortality by differentiating groups: calcifediol yes/no.
Time frame: 02/21/2024 to 04/25/2024
Measure mortality by differentiating groups: calcifediol yes/no.
Measure the need for ICU admission by differentiating the groups calcifediol yes/no.
Time frame: 02/21/2024 to 04/25/2024
Measure the need for ICU admission by differentiating the groups calcifediol yes/no.
3 secondary outcomes
Measure mortality in relation to baseline 25(OH)D levels
Time frame: 02/21/2024 to 04/25/2024
To evaluate the effect of calcifediol treatment on mortality in patients with severe 25(OH)D deficiency
Time frame: 02/21/2024 to 04/25/2024
Measure the composite variable poor prognosis, (death and ICU) by differentiating the groups calcifediol yes/no
Time frame: 02/21/2024 to 04/25/2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Background: PubMed 34395361Ranabhat 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.
- Background: PubMed 31978945Zhu 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.
- Background: PubMed 37605079Bowe 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.
- BackgroundGiliberto 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: PubMed 32648899Wiersinga 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.
- Background: PubMed 34108716Pritchard 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.
- Background: PubMed 36253508Murakami 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.
- Background: PubMed 36724378El-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.
- Background: PubMed 36641201The 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.
- Background: PubMed 35641023Kato 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.
- Background: PubMed 32535032Quesada-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.
- Background: PubMed 35807895Quesada-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.
- Individual participant dataSharing planned: Yes. Anonymized information collected from patients will be shared publicly upon request. All information related to variables or results included in the study will be shared.
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RecruitingObservational study
Determinants of SARS (Severe Acute Respiratory Syndrome)-COV2 (COVID-19) Persistence After Convalescence
COVID-19, Corona Virus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Torres, PhD study chair
Complejo Hospitalario Universitario de Albacete. Albacete. Spain
Jose M Quesada, MD study director
Maimónides Biomedical Research Institute of Córdoba (IMIBIC). Córdoba. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV 2 Pneumonia, run by Complejo Hospitalario Universitario de Albacete at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure mortality by differentiating groups: calcifediol yes/no. (time frame: 02/21/2024 to 04/25/2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06279910, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.