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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579640
Recruitment Status : Completed
First Posted : October 8, 2020
Last Update Posted : April 6, 2022
Sponsor:
Collaborators:
Barts & The London NHS Trust
Pharma Nord
Fischer Family Trust
The AIM Foundation
Synergy Biologics Ltd
Cytoplan Ltd
Information provided by (Responsible Party):
Queen Mary University of London

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Covid19 Acute Respiratory Tract Infection Dietary Supplement: Vitamin D Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : October 27, 2020
Actual Primary Completion Date : June 17, 2021
Actual Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Standard of care (national recommendation of 400 IU/day vitamin D)
Experimental: Intervention: Lower-dose vitamin D
Offer of a daily dose of 800 IU (20 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L
 Dietary Supplement: Vitamin D
Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol
Experimental: Intervention: Higher-dose vitamin D
Offer of a daily dose of 3200 IU (80 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L
 Dietary Supplement: Vitamin D
Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. UK resident
  2. Age ≥16 years
  3. Gives informed consent to participate

Exclusion criteria:

  1. taking digoxin, alfacalcidol, calcitriol, dihydrotachysterol or paricalcitol
  2. known diagnosis of sarcoidosis, primary hyperparathyroidism, renal stones or renal failure requiring dialysis
  3. known allergy to any ingredient in the study capsules (vitamin D, olive oil, caramel, gelatine or glycerol)
  4. pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579640


Locations
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United Kingdom
Queen Mary University of London
London, County (optional), United Kingdom, E1 2AB
Sponsors and Collaborators
Queen Mary University of London
Barts & The London NHS Trust
Pharma Nord
Fischer Family Trust
The AIM Foundation
Synergy Biologics Ltd
Cytoplan Ltd
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT04579640    
Other Study ID Numbers: 289515
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vitamin D
Vitamins
Micronutrients
Physiological Effects of Drugs
Bone Density Conservation Agents