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

Phase 3

Completed

• Conditions: Acute Respiratory Tract Infection; Covid19

• 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

Study Timeline

• Study First Submitted: 2020-10-06
• Study First Submitted QC: 2020-10-06
• Study First Posted: 2020-10-08
• Study Start: 2020-10-27
• Status Verified: 2021-06
• Primary Completion: 2021-06-17
• Study Completion: 2022-02-28
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-04-06

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

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 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 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 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