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

• Sponsor: Queen Mary University of London (Other)
• Overall Status: Completed
• CT.gov ID: NCT04579640
• Collaborator: Barts & The London NHS Trust (Other), Pharma Nord (Industry), Fischer Family Trust (Other), The AIM Foundation (Other), Synergy Biologics Ltd (Other), Cytoplan Ltd (Other)
• Enrollment: 6,200
• Location: 1
• Arms: 3
• Actual Duration (Months): 16.1
• Patients Per Site Per Month: 385.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Acute Respiratory Tract Infection	Dietary Supplement: Vitamin D	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 6200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Oct 27, 2020
• Actual Primary Completion Date: Jun 17, 2021
• Actual Study Completion Date: Feb 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Standard of care (national recommendation of 400 IU/day vitamin D)
Experimental: Intervention: Lower-dose vitamin D Offer of a daily dose of 800 IU (20 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L	Dietary Supplement: Vitamin D; Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol
Experimental: Intervention: Higher-dose vitamin D Offer of a daily dose of 3200 IU (80 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L	Dietary Supplement: Vitamin D; Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol

Outcome Measures

Primary Outcome Measures

1. Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause. [Over 6 months]

Secondary Outcome Measures

1. Proportion of participants developing PCR- or antigen test-positive COVID-19 [Over 6 months]

   Secondary efficacy outcome

2. Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection [Over 6 months]

   Secondary efficacy outcome

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation [Over 6 months]

   Secondary efficacy outcome

10. Proportion of participants who experience COVID-19 requiring hospitalisation [Over 6 months]

    Secondary efficacy outcome

11. Proportion of participants hospitalised for COVID-19 requiring ventilatory support [Over 6 months]

    Secondary efficacy outcome

12. Proportion of participants dying of any cause during participation in the trial [Over 6 months]

    Secondary efficacy outcome

13. Proportion of participants dying of acute respiratory infection during participation in the trial [Over 6 months]

    Secondary efficacy outcome

14. Proportion of participants dying of COVID-19 during participation in the trial [Over 6 months]

    Secondary efficacy outcome

15. Mean end-study 25(OH)D concentration (sub-set of participants having end-study tests of vitamin D status) [6 months]

    Secondary efficacy outcome

16. Proportion of participants experiencing known hypercalcaemia [Over 6 months]

    Secondary safety outcome

17. Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation [Over 6 months]

    Secondary safety outcome

18. Proportion of participants experiencing a serious adverse event of any cause [Over 6 months]

    Secondary safety outcome

19. Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein [Over 6 months]

    Secondary efficacy outcome

20. Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants [Over 6 months]

    Secondary efficacy outcome

21. 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

22. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary University of London	London	County (optional)	United Kingdom	E1 2AB

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Pre-print

Publications

None provided.

• Responsible Party: Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT04579640
• Other Study ID Numbers: 289515
• First Posted: Oct 8, 2020
• Last Update Posted: Apr 6, 2022
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19; Respiratory Tract Infections; Vitamin D

Study Results

No Results Posted as of Apr 6, 2022