Cholecalciferol to Improve the Outcomes of COVID-19 Patients

Last updated on July 2021

Conditions: COVID
Type: Interventional
Phase: Phase 4
Design: Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Two parallel arms randomized controlled trial. A sequential design will be used with the first primary outcome being the primary outcome for the first step. This step will include 200 patients. After reach this point, a review of the primary outcome (change in respiratory SOFA) will be done. According to these results, the Executive committee will decide to proceed the second step of the study and include the remaining 1064 patients to evaluate the second primary outcome (need for high dose of oxygen supplementation or mechanical ventilation).Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: The study will use a placebo identical to the active medication. The members of research team assessing the outcomes will not be aware of the treatment assignment.Primary Purpose: Treatment

See above.

NCT #: NCT04411446
Collaborators: Ag Nac Promoción de la Investigación, el Desarrollo Tecnológico y la Innovación
Investigators: Study Director: Walter Manucha, PhD IMBECU, Univ Nac de Cuyo, Mendoza, Argentina Principal Investigator: Carlos Tajer, MD Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche Principal Investigator: Laura Antonietti, MD Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche Principal Investigator: León Ferder, MD Maimonides University Principal Investigator: Felipe Inserra, MD Universidad Maimónides - Hospital Universitario Austral Principal Investigator: Javier Mariani, MD Hospital de Alta Complejidad El Cruce - Universidad Nacional Arturo Jauretche