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

Covid19 Clinical Trial

— CORONAVIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04579640
• Other study ID #: 289515
• Status: Completed
• Phase: Phase 3
• Start date: October 27, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2021
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6200
• Est. completion date: February 28, 2022
• Est. primary completion date: June 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Tract Infection
• Communicable Diseases
• COVID-19
• Covid19
• Infections
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Vitamin D
Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol

Locations

Country	Name	City	State
United Kingdom	Queen Mary University of London	London	County (optional)

Sponsors (7)

Lead Sponsor	Collaborator
Queen Mary University of London	Barts & The London NHS Trust, Cytoplan Ltd, Fischer Family Trust, Pharma Nord, Synergy Biologics Ltd, The AIM Foundation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause.		Over 6 months
Secondary	Proportion of participants developing PCR- or antigen test-positive COVID-19	Secondary efficacy outcome	Over 6 months
Secondary	Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection	Secondary efficacy outcome	Over 6 months
Secondary	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	Over 6 months
Secondary	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	Over 6 months
Secondary	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	Over 6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	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	6 months
Secondary	Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation	Secondary efficacy outcome	Over 6 months
Secondary	Proportion of participants who experience COVID-19 requiring hospitalisation	Secondary efficacy outcome	Over 6 months
Secondary	Proportion of participants hospitalised for COVID-19 requiring ventilatory support	Secondary efficacy outcome	Over 6 months
Secondary	Proportion of participants dying of any cause during participation in the trial	Secondary efficacy outcome	Over 6 months
Secondary	Proportion of participants dying of acute respiratory infection during participation in the trial	Secondary efficacy outcome	Over 6 months
Secondary	Proportion of participants dying of COVID-19 during participation in the trial	Secondary efficacy outcome	Over 6 months
Secondary	Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status)	Secondary efficacy outcome	6 months
Secondary	Proportion of participants experiencing known hypercalcaemia	Secondary safety outcome	Over 6 months
Secondary	Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation	Secondary safety outcome	Over 6 months
Secondary	Proportion of participants experiencing a serious adverse event of any cause	Secondary safety outcome	Over 6 months
Secondary	Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein	Secondary efficacy outcome	Over 6 months
Secondary	Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants	Secondary efficacy outcome	Over 6 months
Secondary	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	Over 6 months
Secondary	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	Over 6 months

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