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

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ClinicalTrials.gov Identifier: NCT04579640

Recruitment Status : Completed

First Posted : October 8, 2020

Last Update Posted : April 6, 2022

View this study on Beta.ClinicalTrials.gov

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

April 6, 2022

Actual Study Start Date ^ICMJE

October 27, 2020

Actual Primary Completion Date

June 17, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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) [ 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

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 *

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.

* 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

Completed

Actual Enrollment ^ICMJE

6200

Original Estimated Enrollment ^ICMJE

5440

Actual Study Completion Date ^ICMJE

February 28, 2022

Actual Primary Completion Date

June 17, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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