Does the use of UDCA (ursodeoxycholic acid) at baseline reduce the incidence and/or severity of COVID-19?
Recently published preclinical data (link below) suggest ursodeoxycholic acid (UDCA) may inhibit SARS-CoV-2 infection through downregulation of expression of the ACE2 receptor. Although this agent is used in clinical practice for other indications, it has not been evaluated in clinical trials to assess its impact on SARS-CoV-2 infection. The fundamental question being asked is: Does UDCA use at baseline reduce the incidence and/or severity of COVID-19?
Leveraging data in the N3C enclave, assess the impact of UDCA on (1) the risk of SARS-CoV-2 infection and (2) the severity and outcomes of COVID-19 (e.g., hospitalization, mortality, requirement for MV or ECMO, etc.). Quantitatively characterize these risks, accounting for relevant covariates, using retrospective data in the enclave.
Analysis Plan / Research Method
Be explicit about how your study design, research methodology, and analytical plan will address the overall research question and aims. See the detailed guidance on expectations at the submission portal when completing the relevant fields in your proposal.
Be explicit about how your inclusion strategy will rigorously address the overall question and aims.
Be explicit about how your exclusion strategy will rigorously address the overall question and aims.
See inclusion and exclusion sections.
Written report within the N3C Enclave detailing the findings from analyses that support your conclusions and that address the overall research questions and aims. Provide sufficient methodologic detail for independent replication of the work, and an interpretation of the findings and study limitations. All code generated to complete the work will be made available in a deployable format with sufficient documentation/annotation for independent validation. Figures and/or tables in a format specified by NCATS suitable for uploading to the N3C Public Health web site.