HIGH-DOSE VITAMIN D VERSUS PLACEBO TO PREVENT COMPLICATIONS IN COVID-19 PATIENTS: A STRUCTURED SUMMARY OF A STUDY PROTOCOL FOR A RANDOMISED CONTROLLED TRIAL (CARED-TRIAL)

JAVIER MARIANI; CARLOS DANIEL TAJER; LAURA ANTONIETTI; FELIPE INSERRA; LEÓN FERDER; WALTER MANUCHA

TRIALS

BIOMED CENTRAL LTD

Lugar: Londres; Año: 2021 vol. 22 p. 1 - 3

1745-6215

Introduction: Less than a year since the start of the outbreak, the SARS-CoV-2 pandemic has resulted in millions of infected people and over 1.2 deaths worldwide. Current therapeutic options for hospitalized COVID-19 patients are just supportive, and specific treatments showed just a modest benefit. Given the nature of the disease and its consequences, affordable and safe treatments are urgently needed. Vitamin D supplementation has shown to reduce the risk of respiratory tract infections, and it is involved in the pathophysiological pathway of SARS-CoV-2 infection and the severity of the disease. Therefore, we designed the CARED trial to evaluate the effects of a high dose of cholecalciferol on outcomes in COVID-19 patients.Methods and analysis: phase 4, multicentre, randomized, parallel, two-arm, sequential, double-blind and placebo-controlled clinical trial was designed. The study plans to recruit 200 subjects for the first stage and add 1064 for the second stage. Participants are adult with SARS-CoV-2 infection, and high-risk conditions for COVID-19 admitted to general wards. The primary outcome for the first stage is the change in the respiratory SOFA score between baseline and worst value recorded during the first week. For the second stage, the primary outcome is the combined occurrence of requirement >40% FiO2, need for invasive or non-invasive ventilation. Secondary outcomes include components of the primary outcome, length of stay, ICU admission, myocardial infarction, acute kidney injury, venous thromboembolic events, stroke and death. Since recruitment began on August 14, 120 subjects have been randomized.Ethics and dissemination: The study is being conducted according to the Declaration of Helsinki and local regulatory standards for clinical research. Local Institutional Review Boards of participating sites approved the study protocol.The dissemination plan includes the communication of the study results in scientific conferences, the publication in peer-reviewed journals and social media dissemination through websites and social networks of the authors? institutions.Registration number: NCT04411446