Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita

Azidus Brasil0 sitesJuly 2020

Conditionscovid19

InterventionsNitazoxanide Placebo

DrugsNitazoxanide Placebo

Overview

Phase: Phase 2
Intervention: Nitazoxanide
Conditions: covid19
Sponsor: Azidus Brasil
Primary Endpoint: Change in signs and symptoms scale
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Detailed Description

The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only. After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.

Registry

clinicaltrials.gov

Start Date

July 2020

End Date

September 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Azidus Brasil

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Informed consent from patient or legal representative.
•Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49;
•Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
•Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and:
•i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.

Exclusion Criteria

•Participating in another RCT in the past 12 months;
•Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:
•HIV or HTLV virus infection;
•Chronic hepatitis C (HCV) treated with direct antiviral drugs;
•Liver failure;
•Severe renal failure, including dialysis;
•Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
•Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
•Participants who underwent treatment with other antiviral drugs;
•Subject in antineoplastic treatment with chemotherapy or radiation therapy;

Arms & Interventions

nitazoxanide

Subjects will receive nitazonanide 600 mg TID.

Intervention: Nitazoxanide

Placebo

Subjects will receive placebo TID.

Intervention: Placebo

Outcomes

Primary Outcomes

Change in signs and symptoms scale

Time Frame: 21 days

Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).

Secondary Outcomes

Incidence of Treatment-Emergent Adverse Events(21 days)
The proportion of subjects hospitalized after start of treatment and before the end of the study(21 days)
The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study(21 days)
Rate of mortality within 21-days(21 days)
Duration of symptoms(21 days)