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

COVID-19 Clinical Trial

Official title:

Proof of Concept, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Safety and Efficacy of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Moderate Condition.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348409
• Other study ID #: NITFQM0320OR
• Status: Completed
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Nitazoxanide Tablets
Patients will receive nitazoxanide 600 mg BID for 7 days
• Placebo
Patients will receive placebo BID for 7 days

Locations

Country	Name	City	State
Brazil	Hospital Vera Cruz	Campinas	São Paulo
Brazil	Centro de Genomas	São Paulo
Brazil	Hospital Emílio Ribas	São Paulo

Sponsors (6)

Lead Sponsor	Collaborator
Azidus Brasil	Centro de Genomas - UNIFESP, Emilio Ribas Institute of Infectious Diseases, Farmoquimica S.A., Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil, Hospital Vera Cruz

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load	PCR will be done to evaluate the change in viral load	day 1, 4, 7, 14 and 21
Secondary	Evolution of acute respiratory syndrome	Time to wean off oxygen supplementation	21 days
Secondary	Change in Clinical Condition	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)	21 days
Secondary	Hospital discharge	Time to be discharged from hospital	21 days
Secondary	Rate of mortality within 21-days	Evaluation of change in acute respiratory syndrome	21 days
Secondary	Need of mechanical ventilation	Evaluation of change in acute respiratory syndrome	21 days