meta|Evidence - COVID-19

Living meta-analysis and evidence synthesis of therapies for COVID-19

RM08-3008 (Rossignol), 2021 NCT04486313

nitazoxanide (n=472) vs. placebo (n=463)

randomized controlled trial risk of bias NA

Studied treatment

Nitazoxanide
nitazoxanide 300 mgextended release tablets (600 mg per dose) orally with food twice dailyfor five days.

Control treatment

Placebo
matching placebo tablets orally with food twice dailyfor five days.

In addition to study medication, all subjects received a vitamin B complexsupplement twice daily

Patients

COVID 19 outpatients

Subjects at least 12 years of age presenting within 72 hours of onset of symptoms of mild or moderate COVID-19 were eligible to participate in the trial. Minimum symptom requirements were: at least two respiratory symptom domains (head, throat, nose, chest, cough) with a score of≥2 as determined by scoring the InFLUenza Patient-Reported Outcomes (FLU-PRO©) questionnaire administered at screening (only one domain score required to be ≥2 if pulse rate ≥90 beats per minute or respiratory rate ≥16 breaths per minute), with no improvement in overall symptom severity from the prior day.

Method

Double-blind.

Multicenter, 36 centers in the U.S. and Puerto Rico.

Subjects were considered to have reachedsustained response when they experienced (i) a decrease in total FLU-PRO score from the previousdiary entry, (ii) with a corresponding patient assessment that symptoms were at least “somewhatbetter than yesterday,” (iii) no oral temperature ≥100.4°F during the past 24 hours, and (iv) nofuture increase in any of the FLU-PRO domain or subdomain scores through study day 21 exceptto the below pre-defined background levels that were considered not meaningful to patients.

Remark