Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Drug: Nitazoxanide Tablets; Drug: Placebo

• Registration Number: NCT04348409
• Lead Sponsor: Azidus Brasil

Brief Summary

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

Detailed Description

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide for 7 days on top of standard care compared to patients who receive standard care and placebo.

Patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide or placebo.

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-16
• Study Start: 2020-05-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-26
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Informed consent from patient or legal representative.
2. Male or female, aged ≥ 18 years;
3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
4. Signs of respiratory failure requiring oxygen therapy
5. Hospitalized for up to 36h with non-invasive ventilation
6. Negative result for pregnancy test (if applicable).

Exclusion Criteria

1. Participating in another RCT in the past 12 months;
2. Known allergy to nitazoxanide
3. Severely reduced LV function;
4. Severely reduced renal function;
5. Pregnancy or breast feeding;
6. Use of hydroxychloroquine and/or azithromycin in the past 15 days;
7. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nitazoxanide	Nitazoxanide Tablets	Patients will receive nitazoxanide 600 mg BID for 7 days.
Placebo	Placebo	Patients will receive placebo BID for 7 days

Primary Outcome Measures

Name	Time	Method
Viral load	day 1, 4, 7, 14 and 21	PCR will be done to evaluate the change in viral load

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Condition	21 days	WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
Need of mechanical ventilation	21 days	Evaluation of change in acute respiratory syndrome
Evolution of acute respiratory syndrome	21 days	Time to wean off oxygen supplementation
Rate of mortality within 21-days	21 days	Evaluation of change in acute respiratory syndrome
Hospital discharge	21 days	Time to be discharged from hospital

Trial Locations

Locations (3)

Hospital Vera Cruz; 🇧🇷 Campinas, São Paulo, Brazil

Centro de Genomas; 🇧🇷 São Paulo, Brazil

Hospital Emílio Ribas; 🇧🇷 São Paulo, Brazil