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

Queen Mary University of London6,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

6,200

Conditions

Covid19 Acute Respiratory Tract Infection

Interventions

Vitamin DDIETARY_SUPPLEMENT

Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Queen Mary University of London

London, County (optional), United Kingdom

Outcomes

Primary Outcomes

Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.

Time frame: Over 6 months

Secondary Outcomes

Proportion of participants developing PCR- or antigen test-positive COVID-19

Secondary efficacy outcome

Time frame: Over 6 months

Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection

Secondary efficacy outcome

Time frame: Over 6 months

Proportion of participants with asthma who experience one or more exacerbations of asthma requiring treatment with oral corticosteroids and/or requiring hospital treatment

Secondary efficacy outcome

Time frame: Over 6 months

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

Secondary efficacy outcome

Time frame: Over 6 months

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

Secondary efficacy outcome

Time frame: Over 6 months

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

Secondary efficacy outcome

Data from ClinicalTrials.gov

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Time frame: 6 months

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

Secondary efficacy outcome

Time frame: 6 months

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

Secondary efficacy outcome

Time frame: 6 months

Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation

Secondary efficacy outcome

Time frame: Over 6 months

Proportion of participants who experience COVID-19 requiring hospitalisation

Secondary efficacy outcome

Time frame: Over 6 months

Proportion of participants hospitalised for COVID-19 requiring ventilatory support

Secondary efficacy outcome

Time frame: Over 6 months

Proportion of participants dying of any cause during participation in the trial

Secondary efficacy outcome

Time frame: Over 6 months

Proportion of participants dying of acute respiratory infection during participation in the trial

Secondary efficacy outcome

Time frame: Over 6 months

Proportion of participants dying of COVID-19 during participation in the trial

Secondary efficacy outcome

Time frame: Over 6 months

Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status)

Secondary efficacy outcome

Time frame: 6 months

Proportion of participants experiencing known hypercalcaemia

Secondary safety outcome

Time frame: Over 6 months

Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation

Secondary safety outcome

Time frame: Over 6 months

Proportion of participants experiencing a serious adverse event of any cause

Secondary safety outcome

Time frame: Over 6 months

Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein

Secondary efficacy outcome

Time frame: Over 6 months

Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants

Secondary efficacy outcome

Time frame: Over 6 months

Proportion of SARS-CoV-2 vaccinated participants with antigen-specific T cell responses to SARS-CoV-2 spike protein (sub-set of participants)

Secondary efficacy outcome

Time frame: Over 6 months

Frequency of antigen-specific T cells reacting to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants (sub-set of participants)

Secondary efficacy outcome

Time frame: Over 6 months