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Covid19Phase 3CORONAVITNCT04579640

Trial of Vitamin D to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections

A Phase 3 study testing Vitamin D in people with Covid19 and Acute Respiratory Tract Infection, run by Queen Mary University of London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Covid19, Acute Respiratory Tract Infection
What is being tested?
Vitamin D
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,200 participants
Where
1 siteUnited Kingdom
Study dates
27 Oct 2020to 28 Feb 2022
Phase
Phase 3
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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • UK resident
  • Age ≥16 years
  • Gives informed consent to participate

Who cannot join

  • taking digoxin, alfacalcidol, calcitriol, dihydrotachysterol or paricalcitol
  • known diagnosis of sarcoidosis, primary hyperparathyroidism, renal stones or renal failure requiring dialysis
  • known allergy to any ingredient in the study capsules (vitamin D, olive oil, caramel, gelatine or glycerol)
  • pregnancy

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Queen Mary University of London

    London, County (optional), E1 2AB

Other trials in United Kingdom

About this study

Official title: Phase 3 Randomised Controlled Trial of Vitamin D Supplementation to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections in the UK Population

CORONAVIT is an open-label, phase 3, randomised clinical trial testing whether implementation of a test-and-treat approach to correction of sub-optimal vitamin D status results in reduced risk and/or severity of COVID-19 and other acute respiratory infections.

Being tested
Vitamin D
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin DDietary supplement

    Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol

Study groups in NCT04579640
Study groupRoleWhat they receive
ControlNo interventionStandard of care (national recommendation of 400 IU/day vitamin D)
Intervention: Lower-dose vitamin DExperimentalOffer of a daily dose of 800 IU (20 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L
Receives: Dietary Supplement: Vitamin D
Intervention: Higher-dose vitamin DExperimentalOffer of a daily dose of 3200 IU (80 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L
Receives: Dietary Supplement: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.

    Measured: Over 6 months

Secondary outcomes (22)

  1. Proportion of participants developing PCR- or antigen test-positive COVID-19

    Secondary efficacy outcome

    Measured: Over 6 months

  2. Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection

    Secondary efficacy outcome

    Measured: Over 6 months

  3. Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment

    Secondary efficacy outcome

    Measured: Over 6 months

  4. Proportion of participants with COPD who experience one or more exacerbations of COPD requiring treatment with oral corticosteroids and/or antibiotics, and/or requiring hospital treatment

    Secondary efficacy outcome

    Measured: Over 6 months

  5. Proportion of participants who have had PCR-, antigen test- or antibody test-confirmed SARS-CoV-2 infection who report symptoms of COVID-19 lasting more than 4 weeks after onset

    Secondary efficacy outcome

    Measured: Over 6 months

  6. Mean MRC dyspnoea score at the end of the study in people who have had PCR-, antigen test- or antibody test-confirmed SARS-CoV-2 infection and who report symptoms of COVID-19 lasting more than 4 weeks after onset

    Secondary efficacy outcome

    Measured: 6 months

  7. Mean FACIT Fatigue Scale score at the end of the study in people with antigen test- or antibody test-confirmed SARS-CoV-2 infection and who report symptoms of COVID-19 lasting more than 4 weeks after onset

    Secondary efficacy outcome

    Measured: 6 months

  8. Mean COVID-19 Recovery Questionnaire score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection and who report symptoms of COVID-19 lasting more than 4 weeks after onset

    Secondary efficacy outcome

    Measured: 6 months

  9. Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation

    Secondary efficacy outcome

    Measured: Over 6 months

  10. Proportion of participants who experience COVID-19 requiring hospitalisation

    Secondary efficacy outcome

    Measured: Over 6 months

  11. Proportion of participants hospitalised for COVID-19 requiring ventilatory support

    Secondary efficacy outcome

    Measured: Over 6 months

  12. Proportion of participants dying of any cause during participation in the trial

    Secondary efficacy outcome

    Measured: Over 6 months

  13. Proportion of participants dying of acute respiratory infection during participation in the trial

    Secondary efficacy outcome

    Measured: Over 6 months

  14. Proportion of participants dying of COVID-19 during participation in the trial

    Secondary efficacy outcome

    Measured: Over 6 months

  15. Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status)

    Secondary efficacy outcome

    Measured: 6 months

  16. Proportion of participants experiencing known hypercalcaemia

    Secondary safety outcome

    Measured: Over 6 months

  17. Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation

    Secondary safety outcome

    Measured: Over 6 months

  18. Proportion of participants experiencing a serious adverse event of any cause

    Secondary safety outcome

    Measured: Over 6 months

  19. Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein

    Secondary efficacy outcome

    Measured: Over 6 months

  20. Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants

    Secondary efficacy outcome

    Measured: Over 6 months

  21. Proportion of SARS-CoV-2 vaccinated participants with antigen-specific T cell responses to SARS-CoV-2 spike protein (sub-set of participants)

    Secondary efficacy outcome

    Measured: Over 6 months

  22. Frequency of antigen-specific T cells reacting to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants (sub-set of participants)

    Secondary efficacy outcome

    Measured: Over 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2020
  2. Study start27 Oct 2020
  3. Primary completion17 Jun 2021
  4. Study completion28 Feb 2022

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04579640
Sponsor's protocol ID
289515
Acronym
CORONAVIT
Status last verified
Jun 2021
First submitted
6 Oct 2020
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval

Publications

  • Jolliffe DA, Holt H, Greenig M, Talaei M, Perdek N, Pfeffer P, Vivaldi G, Maltby S, Symons J, Barlow NL, Normandale A, Garcha R, Richter AG, Faustini SE, Orton C, Ford D, Lyons RA, Davies GA, Kee F, Griffiths CJ, Norrie J, Sheikh A, Shaheen SO, Relton C, Martineau AR. Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT). BMJ. 2022 Sep 7;378:e071230. doi: 10.1136/bmj-2022-071230.

    PubMed 36215226

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin D in people with Covid19 and Acute Respiratory Tract Infection, run by Queen Mary University of London at 1 site in United Kingdom.

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 4 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 6 Apr 2022. 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 United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause. (time frame: Over 6 months). 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 NCT04579640, 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 6 Apr 2022.

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