Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Barts & The London NHS Trust | OTHER |
| Pharma Nord | INDUSTRY |
| Fischer Family Trust | UNKNOWN |
| The AIM Foundation |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Standard of care (national recommendation of 400 IU/day vitamin D) | |
| Intervention: Lower-dose vitamin D | Experimental | 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 | Experimental | Offer of a daily dose of 3200 IU (80 micrograms) cholecalciferol to individuals with 25-hydroxyvitamin D level <75 nmol/L |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants experiencing at least one doctor-diagnosed or laboratory-confirmed acute respiratory infection of any cause. | Over 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants developing PCR- or antigen test-positive COVID-19 | Secondary efficacy outcome | Over 6 months |
| Proportion of participants who are prescribed one or more courses of antibiotic treatment for acute respiratory infection |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary University of London | London | County (optional) | E1 2AB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36215226 | Derived | Jolliffe DA, Holt H, Greenig M, Talaei M, Perdek N, Pfeffer P, Vivaldi G, Maltby S, Symons J, Barlow NL, Normandale A, Garcha R, Richter AG, Faustini SE, Orton C, Ford D, Lyons RA, Davies GA, Kee F, Griffiths CJ, Norrie J, Sheikh A, Shaheen SO, Relton C, Martineau AR. Effect of a test-and-treat approach to vitamin D supplementation on risk of all cause acute respiratory tract infection and covid-19: phase 3 randomised controlled trial (CORONAVIT). BMJ. 2022 Sep 7;378:e071230. doi: 10.1136/bmj-2022-071230. |
Not provided
Not provided
De-identified IPD will be shared with other researchers subject to terms of Data Transfer Agreement and IRB approval
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| UNKNOWN |
| Synergy Biologics Ltd | UNKNOWN |
| Cytoplan Ltd | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Secondary efficacy outcome
| 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 | 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 | 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 | 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 | 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 | 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 | 6 months |
| Proportion of participants who experience one or more acute respiratory infections requiring hospitalisation | Secondary efficacy outcome | Over 6 months |
| Proportion of participants who experience COVID-19 requiring hospitalisation | Secondary efficacy outcome | Over 6 months |
| Proportion of participants hospitalised for COVID-19 requiring ventilatory support | Secondary efficacy outcome | Over 6 months |
| Proportion of participants dying of any cause during participation in the trial | Secondary efficacy outcome | Over 6 months |
| Proportion of participants dying of acute respiratory infection during participation in the trial | Secondary efficacy outcome | Over 6 months |
| Proportion of participants dying of COVID-19 during participation in the trial | Secondary efficacy outcome | 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 | 6 months |
| Proportion of participants experiencing known hypercalcaemia | Secondary safety outcome | Over 6 months |
| Proportion of participants experiencing a probable or definite adverse reaction to vitamin D supplementation | Secondary safety outcome | Over 6 months |
| Proportion of participants experiencing a serious adverse event of any cause | Secondary safety outcome | Over 6 months |
| Proportion of SARS-CoV-2 vaccinated participants with antibodies to SARS-CoV-2 spike protein | Secondary efficacy outcome | Over 6 months |
| Median titre of antibodies to SARS-CoV-2 spike protein in SARS-CoV-2 vaccinated participants | Secondary efficacy outcome | 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 | 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 | Over 6 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |