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Completed

NCT Number: NCT04579640

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

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.

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Key information

Conditions

Covid19 Acute Respiratory Tract Infection COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Queen Mary University of London

London, County (optional), E1 2AB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Vitamin D

Dietary Supplement

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

Primary outcomes

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

    Time frame: Over 6 months

Secondary outcomes

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

  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

    Time frame: Over 6 months

    Secondary efficacy outcome

  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

    Time frame: Over 6 months

    Secondary efficacy outcome

  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

    Time frame: 6 months

    Secondary efficacy outcome

  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

    Time frame: 6 months

    Secondary efficacy outcome

  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

    Time frame: 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: 6 months

    Secondary efficacy outcome

  16. Proportion of participants experiencing known hypercalcaemia

    Time frame: Over 6 months

    Secondary safety outcome

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

    Time frame: Over 6 months

    Secondary safety outcome

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

    Time frame: Over 6 months

    Secondary safety outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

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

    Time frame: Over 6 months

    Secondary efficacy outcome

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Barts & The London NHS Trust
  • Cytoplan Ltd
  • Fischer Family Trust
  • Pharma Nord
  • Synergy Biologics Ltd
  • The AIM Foundation

Registry information

Official study 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

Acronym: CORONAVIT

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 8, 2020
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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