Lead Investigator: Gus Slotman, Inspira Health Network
Title of Proposal Research: USING PRE-RANDOMIZATION DATA TO IDENTIFY PATIENTS WITH COVID-19 AMONG WHOM FLUVOXAMINE OR IVERMECTIN IMPROVED OUTCOMES
Vivli Data Request: 8569
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
LAY SUMMARY: Discovering effective treatments of COVID-19 infection is vital. Randomized clinical trials (RCT) of established drugs attempt to repurpose generic medications with potential efficacy against COVID-19. Dexamethasone was the first successful repurposed drug for COVID-19 in the RECOVERY RCT. Among others, in the TOGETHER group RCT COVID-19 patients receiving fluvoxamine had a statistically significant 5% lower risk than placebo of hospitalization, defined as either retention in a COVID-19 emergency setting > 6 hours or transfer to a tertiary hospital due to COVID-19. Conversely, in the TOGETHER RCT testing the anti-parasite medication ivermectin in COVID-19, with the same end-points as the fluvoxamine RCT, adverse outcomes were reduced by only a non-significant 1.6%.
Hypothesis: The clinical definitions used as entry criteria for TOGETHER RCTs of fluvoxamine and ivermectin may have enrolled so many patients whose pathophysiology could not benefit from the study drugs that their true treatment effects were diluted to suboptimal efficacy for fluvoxamine and to invisibility for ivermectin. The present study proposes to determine whether or not it is possible to predict from pre-randomization TOGETHER RCT data which COVID-19 patients were able to benefit most from fluvoxamine and/or ivermectin. If this investigation identifies such patients within the TOGETHER RCTs of fluvoxamine and/or ivermectin in COVID-19, then the predictive models generated can be used to match COVID-19 patients predicted to respond most effectively with one of these repurposed drugs.
A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine, Ivermectin, Doxasozin and Interferon Lambda 1A in Mild COVID-19 and High Risk of Complications
Data Contributor: Platform Life Sciences
Study ID: NCT04727424
Sponsor ID: TOGETHER_2