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drugset / Trial / NCT04342689

The Role of Resistant Starch in COVID-19 Infection

NCT04342689 ↗

Phase 2/3 Terminated 226 enrolled Yale University University of Michigan · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a multicenter randomized trial to evaluate the efficacy of administering a dietary supplement containing resistant starch to non-hospitalized COVID-19 positive subjects, The intervention will begin as soon as possible after subjects test positive for COVID-19 and continue for 14 days. Investigators hypothesize that short-term administration of a dietary supplement containing resistant starch has the potential to reduce rates of hospitalization and improve time to clinical recovery and symptoms in non-hospitalized COVID-19 positive patients.

Timeline

Start
2020-06-03
Primary completion
2021-04-15
Completion
2021-04-15

Outcome

Missed primary endpoint

Stopped (Enrollment): “Study was terminated due to low enrollment.”

registry analysis (superiority test); Control vs Intervention; p = 0.99; Chi-squared NCT04342689 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject resistant starch Unknown 20 g —

Indications

COVID-19