Trial of Vitamin D to Reduce Risk and Severity of COVID-19 and Other Acute Respiratory Infections
Phase 3
Completed
- Conditions
- Acute Respiratory Tract InfectionCovid19
- Interventions
- Dietary Supplement: Vitamin D
- Registration Number
- NCT04579640
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6200
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention: Lower-dose vitamin D Vitamin D Offer of a daily dose of 800 IU (20 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level \<75 nmol/L Intervention: Higher-dose vitamin D Vitamin D Offer of a daily dose of 3200 IU (80 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level \<75 nmol/L
- Primary Outcome Measures
Name Time Method Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause. Over 6 months
- Secondary Outcome Measures
Name Time Method Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation Over 6 months Secondary safety outcome
Proportion of participants developing PCR- or antigen test-positive COVID-19 Over 6 months Secondary efficacy outcome
Proportion of participants dying of any cause during participation in the trial Over 6 months Secondary efficacy outcome
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 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 experiencing a serious adverse event of any cause Over 6 months Secondary safety 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
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
Proportion of participants hospitalised for COVID-19 requiring ventilatory support 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 SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein 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
Proportion of participants who experience COVID-19 requiring hospitalisation Over 6 months Secondary efficacy outcome
Proportion of participants experiencing known hypercalcaemia Over 6 months Secondary safety 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
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
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 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
Proportion of participants dying of COVID-19 during participation in the trial 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
Trial Locations
- Locations (1)
Queen Mary University of London
🇬🇧London, County (optional), United Kingdom