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

Phase 3

Recruiting

• Conditions: covid19
• Interventions: Drug: Placebo; Drug: Nitazoxanide

• Registration Number: NCT04423861
• Lead Sponsor: Azidus Brasil

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-09
• Study Start: 2022-06-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 380

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%;

6. Negative result for pregnancy test (if applicable).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Need of mechanical ventilation	14 days	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)

Secondary Outcome Measures

Name	Time	Method
Change in the pulmonary condition	Baseline, Day 7 and Day 14	Evaluation of change in oximetry, respiratory rate and need for oxygen therapy
Change in Clinical Condition	Baseline, Day 7 and Day 14	Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction
Change in tomographic pulmonary condition	Baseline, Day 7	Evaluation of change in chest CT
Rate of mortality within 14-days	14 days	Evaluation of change in acute respiratory syndrome
Change in inflammatory markers	Baseine, Day 7, Day 14	Evaluation of change in inflammatory markers d-dimer and IL-6

Trial Locations

Locations (1)

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