SARS-CoV 2Phase 2COVIDIOLNCT04366908
Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome
A Phase 2 study testing BAT + Calcifediol and BAT in people with SARS-CoV 2 and COVID19, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- SARS-CoV 2, COVID19, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- BAT + Calcifediol and BAT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 1 siteSpain
- Study dates
- 7 May 2020to 19 Apr 2022
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages
- Intolerance or allergy to Calcifediol or its components
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)
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
- Being tested
- BAT + Calcifediol, BAT
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT + CalcifediolDrug
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
BATDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Drug: BAT + Calcifediol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission to Intensive Care Unit
Proportion of subjects who enter the Intensive Care Unit
Measured: At day 28.
Death
Proportion of subjects who die.
Measured: At day 28.
Secondary outcomes (11)
Time from onset of symptoms to discharge of patients in conventional hospitalization
Compare the time (in days) at discharge in newly hospitalized patients on non-invasive ventilation.
Measured: At day 28.
ICU - Time until admission
In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until admission to Intensive Care Unit
Measured: At day 28.
ICU - Time mechanical ventilation is removed
In patients who, in the course of their evolution, required admission with mechanical ventilation in the ICU, time until mechanical ventilation is removed.
Measured: At day 28.
Evaluation of the inflammatory markers related with the disease
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.
Measured: At day 28.
Vitamin D metabolites
Evaluation of the Vitamin D metabolites.
Measured: At day 28.
Evolution in SatO2
Compare the evolution in SatO2
Measured: At day 28.
Evolution in the Sat O2/FiO2 ratio.
Compare the evolution in the Sat O2/FiO2 ratio
Measured: At day 28.
Evolution in the degree of dyspnea
Compare the evolution in the degree of dyspnea using the analog Borg scale
Measured: At day 28.
Evolution of the improvement of radiological findings by simple radiology
Compare the evolution of radiological findings by simple radiology in the recruited subjects since their beginning in the trial until they end the trial
Measured: At day 28.
Incidence of adverse events
Incidence of adverse events related to medication and its administration.
Measured: At day 28.
Appearance of hemorrhagic or thrombotic phenomena
Incidence in the appearance of hemorrhagic or thrombotic phenomena.
Measured: At day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start7 May 2020
- Primary completion19 Apr 2022
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV 2Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia, Dynamic Solutions, Faes Farma, S.A.
- Responsible party
- Sponsor
- Investigators
- José López Miranda, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366908
- Sponsor's protocol ID
- COVIDIOL
- Acronym
- COVIDIOL
- Status last verified
- Mar 2023
- First submitted
- 25 Apr 2020
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the information will be published and accessible. It will be also available on demand.
Publications
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.
PubMed 34029377
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment With Calcifediol of COVID-19 Coronavirus-induced Acute Respiratory Syndrome (SARS)
- ClinicalTrials.gov ID
- NCT04366908
- Acronym / sponsor ID
- COVIDIOL / COVIDIOL
- Conditions
- SARS-CoV 2, COVID19, SARS (Severe Acute Respiratory Syndrome), Cytokine Release Syndrome, Cytokine Storm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Collaborators
- Junta de Andalucia, Dynamic Solutions, Faes Farma, S.A.
- Study start
- 7 May 2020 (actual)
- Primary completion
- 19 Apr 2022 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 29 Apr 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - best available therapy | Active comparator | Drug: BATThe 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). |
| Treatment | Experimental | Drug: BAT + CalcifediolThe 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Being treated with Calcifediol or Cholecalciferol in any of its presentations and dosages
- Intolerance or allergy to Calcifediol or its components
- Pregnancy
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 |
|---|---|---|
| BAT + CalcifediolThe 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 | Treatment |
| BATThe 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 | Control - best available therapy |
Primary outcome
Admission to Intensive Care Unit
Time frame: At day 28.
Proportion of subjects who enter the Intensive Care Unit
Death
Time frame: At day 28.
Proportion of subjects who die.
11 secondary outcomes
Time from onset of symptoms to discharge of patients in conventional hospitalization
Time frame: At day 28.
ICU - Time until admission
Time frame: At day 28.
ICU - Time mechanical ventilation is removed
Time frame: At day 28.
Evaluation of the inflammatory markers related with the disease
Time frame: At day 28.
Vitamin D metabolites
Time frame: At day 28.
Evolution in SatO2
Time frame: At day 28.
Evolution in the Sat O2/FiO2 ratio.
Time frame: At day 28.
Evolution in the degree of dyspnea
Time frame: At day 28.
Evolution of the improvement of radiological findings by simple radiology
Time frame: At day 28.
Incidence of adverse events
Time frame: At day 28.
Appearance of hemorrhagic or thrombotic phenomena
Time frame: At day 28.
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 3 Mar 2023.
- Derived from this study: PubMed 34029377Stroehlein 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.
- Individual participant dataSharing planned: Yes. All the information will be published and accessible. It will be also available on demand.
Related trials for SARS-CoV 2
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Not yet recruiting
Effect of MxA Guidance on Antiviral Treatment in Respiratory Viral Infections
Respiratory Viral Infections, Influenza
Recruiting
Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.
COVID-19, Long COVID
Active, not recruiting
Clinical Validation of the NowFuture Digital Flu / COVID Test in Anterior Nasal Samples for Over-the-Counter (OTC) Use in Australia
SARS CoV 2 Infection, Influenza A Virus Infection
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.
José López Miranda, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BAT + Calcifediol and BAT in people with SARS-CoV 2 and COVID19, run by Maimónides Biomedical Research Institute of Córdoba 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 4 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 3 Mar 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Admission to Intensive Care Unit (time frame: At day 28.). 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 NCT04366908, which also lists 1 linked publication.
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 3 Mar 2023.