Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19

covid19 Clinical Trial

Official title:

A Phase III, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Non-critical Condition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04423861
• Other study ID #: NITFQM0920OR-III
• Status: Recruiting
• Phase: Phase 3
• Start date: June 22, 2022
• Est. completion date: March 2023

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: Florentino de Araujo Cardoso Filho, MD, PhD
• Phone: +55 19 991232882
• Email: florentino.cardoso[@]hospitalcare.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.

Description:

This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical 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 BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care..

Therefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• 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

4. chain reaction (RT-PCR) from any diagnostic sampling source;

5. Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation <98%;

7. 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. Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);

7. History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;

8. Ongoing antineoplastic treatment with chemotherapy or radiation therapy;

9. Diagnose of severe autoimmune diseases in immunosuppression;

10. Transplanted patients;

11. 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
• covid19

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital Vera Cruz	Campinas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Azidus Brasil	Farmoquimica S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need of mechanical ventilation	Evaluation of change in acute respiratory syndrome using 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)	14 days
Secondary	Change in the pulmonary condition	Evaluation of change in oximetry, respiratory rate and need for oxygen therapy	Baseline, Day 7 and Day 14
Secondary	Change in Clinical Condition	Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction	Baseline, Day 7 and Day 14
Secondary	Change in tomographic pulmonary condition	Evaluation of change in chest CT	Baseline, Day 7
Secondary	Rate of mortality within 14-days	Evaluation of change in acute respiratory syndrome	14 days
Secondary	Change in inflammatory markers	Evaluation of change in inflammatory markers d-dimer and IL-6	Baseine, Day 7, Day 14