Acute Respiratory Tract Infection, Covid19
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol
Sponsors
Barts & The London NHS Trust
Pharma Nord
Fischer Family Trust
The AIM Foundation
Synergy Biologics Ltd
Cytoplan Ltd
Queen Mary University of London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause. | Over 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection | 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 | 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 | 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 | 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 | 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 | 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 | 6 months | Secondary efficacy outcome |
| Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation | Over 6 months | Secondary efficacy outcome |
| Proportion of participants who experience COVID-19 requiring hospitalisation | Over 6 months | Secondary efficacy outcome |
| Proportion of participants hospitalised for COVID-19 requiring ventilatory support | Over 6 months | Secondary efficacy outcome |
| Proportion of participants developing PCR- or antigen test-positive COVID-19 | Over 6 months | Secondary efficacy outcome |
| Proportion of participants dying of acute respiratory infection during participation in the trial | Over 6 months | Secondary efficacy outcome |
| Proportion of participants dying of COVID-19 during participation in the trial | 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) | 6 months | Secondary efficacy outcome |
| Proportion of participants experiencing known hypercalcaemia | Over 6 months | Secondary safety outcome |
| Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation | Over 6 months | Secondary safety outcome |
| Proportion of participants experiencing a serious adverse event of any cause | Over 6 months | Secondary safety outcome |
| Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein | Over 6 months | Secondary efficacy outcome |
| Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants | 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) | 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) | Over 6 months | Secondary efficacy outcome |
| Proportion of participants dying of any cause during participation in the trial | Over 6 months | Secondary efficacy outcome |
Countries
United Kingdom
Outcome results
None listed