Nitazoxanide Versus Placebo for the Treatment of Hospitalized Subjects With Severe Acute Respiratory Illness

NCT02057757 ↗

Phase 2 Completed 260 enrolled National Institute of Allergy and Infectious Diseases (NIAID) Mexican Emerging Infectious Diseases Clinical Research Network · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Respiratory viruses are a significant cause of hospitalization for respiratory tract infections. This study will evaluate the safety, effectiveness, and tolerability of nitazoxanide (NTZ) in treating severe acute respiratory illness (SARI) in people who are hospitalized.

Timeline

Start: 2014-02
Primary completion: 2017-05
Completion: 2018-01

Outcome

Missed primary endpoint

paper Treatment with NTZ did not reduce the duration of hospital stay in severe influenza-like illness. PMID 30753384 ↗

registry analysis (equivalence test); Nitazoxanide (NTZ) vs Placebo; p = 0.5634; Fay - Shaw NCT02057757 ↗

Publications

Gamino-Arroyo AE, Guerrero ML, McCarthy S, Ramirez-Venegas A, Llamosas-Gallardo B, Galindo-Fraga A, Moreno-Espinosa S, Roldan-Aragon Y, Araujo-Melendez J, Hunsberger S, Ibarra-Gonzalez V, Martinez-Lopez J, Garcia-Andrade LA, Kapushoc H, Holley HP, Smolskis MC, Ruiz-Palacios GM, Beigel JH; Mexico Emerging Infectious Diseases Clinical Research Network (LaRed). Efficacy and Safety of Nitazoxanide in Addition to Standard of Care for the Treatment of Severe Acute Respiratory Illness. Clin Infect Dis. 2019 Nov 13;69(11):1903-1911. doi: 10.1093/cid/ciz100.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nitazoxanide	Other / unclassified	100 mg	Oral
Subject	Nitazoxanide	Other / unclassified	200 mg	Oral
Subject	Nitazoxanide	Other / unclassified	600 mg	Oral