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Trial of Vitamin D to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections (CORONAVIT) (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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04579640
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Barts Charity
Pharma Nord
Information provided by (Responsible Party):
Queen Mary University of London

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5440 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
Estimated Study Start Date : October 19, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




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 antigen test-positive COVID-19 [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  2. Proportion of participants developing 'probable COVID-19', as adjudged using a validated symptom score [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  3. Proportion of participants developing antigen test-positive influenza [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  4. Proportion of participants reporting symptoms of acute respiratory infection [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  5. 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

  6. 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

  7. 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

  8. Proportion of participants who have had 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

  9. Mean MRC dyspnoea score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection [ Time Frame: 6 months ]
    Secondary efficacy outcome

  10. Mean FACIT Fatigue Scale score at the end of the study in people who have had antigen test- or antibody test-confirmed SARS-CoV-2 infection [ Time Frame: 6 months ]
    Secondary efficacy outcome

  11. 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 [ Time Frame: 6 months ]
    Secondary efficacy outcome

  12. Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  13. Proportion of participants who experience COVID-19 requiring hospitalisation [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  14. Proportion of participants hospitalised for COVID-19 requiring ventilatory support [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  15. Proportion of participants who experience influenza requiring hospitalisation [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  16. Proportion of participants dying of any cause during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  17. Proportion of participants dying of acute respiratory infection during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  18. Proportion of participants dying of COVID-19 during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

  19. Proportion of participants dying of influenza during participation in the trial • mean end-study 25(OH)D concentrations (sub-set of participants having end-study tests of vitamin D status) [ Time Frame: Over 6 months ]
    Secondary efficacy outcome

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

  21. Proportion of participants experiencing known hypercalcaemia [ Time Frame: Over 6 months ]
    Secondary safety outcome

  22. Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation [ Time Frame: Over 6 months ]
    Secondary safety outcome

  23. Proportion of participants experiencing a serious adverse event of any cause [ Time Frame: Over 6 months ]
    Secondary safety outcome



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Age ≥16 years
  2. Gives informed consent to participate

Exclusion criteria:

  1. Taking digoxin, an oral vitamin D analogue or a prescription-only formulation of vitamin D
  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, gelatine or glycerol)
  4. Pregnant, breastfeeding or planning pregnancy

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


Contacts
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Contact: Adrian R Martineau, MD PhD +44 207 882 2551 a.martineau@qmul.ac.uk
Contact: David A Jolliffe, PhD +44 7920648370 d.a.jolliffe@qmul.ac.uk

Locations
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United Kingdom
Queen Mary University of London
London, United Kingdom, E1 2AB
Sponsors and Collaborators
Queen Mary University of London
Barts Charity
Pharma Nord
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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: October 8, 2020
Last Verified: October 2020
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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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents