Does molnupiravir show a reduction of severe outcomes of COVID-19 in the N3C Data Enclave

Contract Description

Molnupiravir has demonstrated variable effects on the risk of hospitalization or mortality among outpatients with COVID-19.  Prior results from the randomized, placebo-controlled MOVe-OUT trial demonstrated a statistically significant reduction in the risk of all-cause hospitalization or death in unvaccinated patients at increased risk, while a more recent randomized open-label study (PANORAMIC) in a high-risk vaccinated population disclosed no impact on all-cause hospitalization or death (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)02597-1/fulltext).  The question to be addressed is: Does molnupiravir reduce the risk of hospitalization or death within one month of COVID-19 in at-risk patients with COVID-19 in the N3C population, controlling for confounding variables such as vaccination, risk factors for severe outcomes, concomitant therapy, and variant epoch.

Contract Aims

Does molnupiravir reduce the risk of hospitalization or death within one month of COVID-19 in at-risk patients with COVID-19 in the N3C population, controlling for confounding variables such as vaccination, risk factors for severe outcomes, concomitant therapy, and variant epoch.

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.

Expected Results

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Inclusion Criteria

Be explicit about how your inclusion strategy will rigorously address the overall question and aims.

Exclusion Criteria

Be explicit about how your exclusion strategy will rigorously address the overall question and aims.

Phenotype

Be explicit about how you will define the key phenotype(s) in the Aims and how you will address any confounders to the phenotype definition(s).

Deliverables

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.