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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 : Active, not recruiting
First Posted : October 8, 2020
Last Update Posted : May 26, 2021
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

Tracking Information
First Submitted Date  ICMJE October 6, 2020
First Posted Date  ICMJE October 8, 2020
Last Update Posted Date May 26, 2021
Actual Study Start Date  ICMJE October 27, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause. [ Time Frame: Over 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2021)
  • Proportion of participants developing PCR- or antigen test-positive COVID-19 [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants who experience COVID-19 requiring hospitalisation [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants hospitalised for COVID-19 requiring ventilatory support [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants dying of any cause during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants dying of acute respiratory infection during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants dying of COVID-19 during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • 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
  • Proportion of participants experiencing known hypercalcaemia [ Time Frame: Over 6 months ]
    Secondary safety outcome
  • Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation [ Time Frame: Over 6 months ]
    Secondary safety outcome
  • Proportion of participants experiencing a serious adverse event of any cause [ Time Frame: Over 6 months ]
    Secondary safety outcome
  • Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2020)
  • Proportion of participants developing antigen test-positive COVID-19 [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants developing 'probable COVID-19', as adjudged using a validated symptom score [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants developing antigen test-positive influenza [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants reporting symptoms of acute respiratory infection [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants who experience COVID-19 requiring hospitalisation [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants hospitalised for COVID-19 requiring ventilatory support [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants who experience influenza requiring hospitalisation [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants dying of any cause during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants dying of acute respiratory infection during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • Proportion of participants dying of COVID-19 during participation in the trial [ Time Frame: Over 6 months ]
    Secondary efficacy outcome
  • 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
  • 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
  • Proportion of participants experiencing known hypercalcaemia [ Time Frame: Over 6 months ]
    Secondary safety outcome
  • Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation [ Time Frame: Over 6 months ]
    Secondary safety outcome
  • Proportion of participants experiencing a serious adverse event of any cause [ Time Frame: Over 6 months ]
    Secondary safety outcome
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Vitamin D to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Covid19
  • Acute Respiratory Tract Infection
Intervention  ICMJE Dietary Supplement: Vitamin D
Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: Vitamin D
  • 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
    Intervention: Dietary Supplement: Vitamin D
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 26, 2020)
6200
Original Estimated Enrollment  ICMJE
 (submitted: October 6, 2020)
5440
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04579640
Other Study ID Numbers  ICMJE 289515
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Analytic Code
Responsible Party Queen Mary University of London
Study Sponsor  ICMJE Queen Mary University of London
Collaborators  ICMJE
  • Barts & The London NHS Trust
  • Pharma Nord
  • Fischer Family Trust
  • The AIM Foundation
  • Synergy Biologics Ltd
  • Cytoplan Ltd
Investigators  ICMJE Not Provided
PRS Account Queen Mary University of London
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP