Clinical trial NCT04579640: Trial of Vitamin D to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Acute Respiratory Tract Infection
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Barts & The London NHS Trust
name: Pharma Nord
name: Fischer Family Trust
name: The AIM Foundation
name: Synergy Biologics Ltd
name: Cytoplan Ltd
First posted: 2020-10-08
Enrollment: 6200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.
timeFrame: Over 6 months
Secondary outcomes:
measure: Proportion of participants developing PCR- or antigen test-positive COVID-19
timeFrame: Over 6 months
measure: Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection
timeFrame: Over 6 months
measure: Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment
timeFrame: Over 6 months
measure: 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
timeFrame: Over 6 months
measure: 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
timeFrame: Over 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation
timeFrame: Over 6 months
measure: Proportion of participants who experience COVID-19 requiring hospitalisation
timeFrame: Over 6 months
measure: Proportion of participants hospitalised for COVID-19 requiring ventilatory support
timeFrame: Over 6 months
measure: Proportion of participants dying of any cause during participation in the trial
timeFrame: Over 6 months
measure: Proportion of participants dying of acute respiratory infection during participation in the trial
timeFrame: Over 6 months
measure: Proportion of participants dying of COVID-19 during participation in the trial
timeFrame: Over 6 months
measure: Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status)
timeFrame: 6 months
measure: Proportion of participants experiencing known hypercalcaemia
timeFrame: Over 6 months
measure: Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation
timeFrame: Over 6 months
measure: Proportion of participants experiencing a serious adverse event of any cause
timeFrame: Over 6 months
measure: Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein
timeFrame: Over 6 months
measure: Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants
timeFrame: Over 6 months
measure: Proportion of SARS-CoV-2 vaccinated participants with antigen-specific T cell responses to SARS-CoV-2 spike protein (sub-set of participants)
timeFrame: Over 6 months
measure: Frequency of antigen-specific T cells reacting to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants (sub-set of participants)
timeFrame: Over 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Queen Mary University of London
state: County (optional)
Study officials:
References:
citation: 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.