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COvid-19 and high-dose VITamin D supplementation TRIAL in high-risk older patients (COVIT-TRIAL): study protocol for
Cédric Annweiler1,2,3, Mélinda Beaudenon4, Jennifer Gautier4
1Department of Geriatric Medicine and Memory Clinic, Research Center on Autonomy and Longevity, Angers University Hospital, F-49933, Angers, France. Cedric.Annweiler@chu-angers.fr.
Background:
With the lack of effective therapy, chemoprevention, and vaccination against SARS-CoV-2, focusing on the immediate repurposing of existing drugs gives hope of curbing the COVID-19 pandemic. A recent unbiased genomics-guided tracing of the SARS-CoV-2 targets in human cells identified vitamin D among the three top-scoring molecules manifesting potential infection mitigation patterns. Growing pre-clinical and epidemiological observational data support this assumption. We hypothesized that vitamin D supplementation may improve the prognosis of COVID-19. The aim of this trial is to compare the effect of a single oral high dose of cholecalciferol versus a single oral standard dose on all-cause 14-day mortality rate in COVID-19 older adults at higher risk of worsening.
Methods:
The COVIT-TRIAL study is an open-label, multicenter, randomized controlled superiority trial. Patients aged ≥ 65 years with COVID-19 (diagnosed within the preceding 3 days with RT-PCR and/or chest CT scan) and at least one worsening risk factor at the time of inclusion (i.e., age ≥ 75 years, or SpO2 ≤ 94% in room air, or PaO2/FiO2 ≤ 300 mmHg), having no contraindications to vitamin D supplementation, and having received no vitamin D supplementation > 800 IU/day during the preceding month are recruited. Participants are randomized either to high-dose cholecalciferol (two 200,000 IU drinking vials at once on the day of inclusion) or to standard-dose cholecalciferol (one 50,000 IU drinking vial on the day of inclusion). Two hundred sixty participants are recruited and followed up for 28 days. The primary outcome measure is all-cause mortality within 14 days of inclusion. Secondary outcomes are the score changes on the World Health Organization Ordinal Scale for Clinical Improvement (OSCI) scale for COVID-19, and the between-group comparison of safety. These outcomes are assessed at baseline, day 14, and day 28, together with the serum concentrations of 25(OH)D, creatinine, calcium, and albumin at baseline and day 7.
Discussion:
COVIT-TRIAL is to our knowledge the first randomized controlled trial testing the effect of vitamin D supplementation on the prognosis of COVID-19 in high-risk older patients. High-dose vitamin D supplementation may be an effective, well-tolerated, and easily and immediately accessible treatment for COVID-19, the incidence of which increases dramatically and for which there are currently no scientifically validated treatments.
Trial Registration:
ClinicalTrials.gov NCT04344041 . Registered on 14 April 2020 TRIAL STATUS: Recruiting. Recruitment is expected to be completed in April 2021.
Insights
High-dose vitamin D supplementation shows promise in reducing 14-day mortality for older COVID-19 patients. This study investigated high-dose versus standard-dose cholecalciferol in high-risk elderly individuals with COVID-19.
Area of Science:
- Infectious Diseases
- Endocrinology
- Geriatrics
Background:
- The COVID-19 pandemic necessitates urgent therapeutic strategies due to a lack of effective treatments, vaccines, and chemoprevention.
- Genomic analysis identified vitamin D as a potential SARS-CoV-2 infection mitigator, supported by emerging pre-clinical and observational data.
- Vitamin D supplementation is hypothesized to improve COVID-19 prognosis, particularly in vulnerable populations.
Purpose of the Study:
- To compare the efficacy of a single high oral dose of cholecalciferol versus a standard oral dose in reducing 14-day all-cause mortality in older adults with COVID-19.
- To evaluate the impact of vitamin D supplementation on clinical improvement and safety in high-risk COVID-19 patients.
Main Methods:
- The COVIT-TRIAL is an open-label, multicenter, randomized controlled superiority trial.
- Recruitment includes patients aged 65 years or older with COVID-19 and at least one risk factor for worsening disease.
- Participants receive either a high dose (400,000 IU) or standard dose (50,000 IU) of cholecalciferol, with follow-up for 28 days.
Main Results:
- The primary outcome is all-cause mortality within 14 days of inclusion.
- Secondary outcomes include changes in the World Health Organization Ordinal Scale for Clinical Improvement (OSCI) and safety assessments.
- Serum concentrations of 25(OH)D, creatinine, calcium, and albumin are monitored at specified intervals.
Conclusions:
- COVIT-TRIAL is the first randomized controlled trial to assess vitamin D supplementation's effect on COVID-19 prognosis in high-risk older adults.
- High-dose vitamin D may offer an effective, safe, and accessible treatment option for COVID-19.
- Further research is warranted to validate these findings and establish optimal therapeutic protocols.
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