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

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.

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Nitazoxanide Tablets; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Centro de Genomas
  • São Paulo, Brazil
    • Hospital Emílio Ribas
  • São Paulo
    • Campinas, São Paulo, Brazil
      • Hospital Vera Cruz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nitazoxanide; Patients will receive nitazoxanide 600 mg BID for 7 days.	Drug: Nitazoxanide Tablets; Patients will receive nitazoxanide 600 mg BID for 7 days
Placebo Comparator: Placebo; Patients will receive placebo BID for 7 days	Drug: Placebo; Patients will receive placebo BID for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Viral load	PCR will be done to evaluate the change in viral load	day 1, 4, 7, 14 and 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of acute respiratory syndrome	Time to wean off oxygen supplementation	21 days
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
Hospital discharge	Time to be discharged from hospital	21 days
Rate of mortality within 21-days	Evaluation of change in acute respiratory syndrome	21 days
Need of mechanical ventilation	Evaluation of change in acute respiratory syndrome	21 days

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Collaborators: Farmoquimica S.A.; Hospital Vera Cruz; Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil; Centro de Genomas - UNIFESP; Emilio Ribas Institute of Infectious Diseases

Publications and helpful links

General Publications

• Blum VF, Cimerman S, Hunter JR, Tierno P, Lacerda A, Soeiro A, Cardoso F, Bellei NC, Maricato J, Mantovani N, Vassao M, Dias D, Galinskas J, Janini LMR, Santos-Oliveira JR, Da-Cruz AM, Diaz RS. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial. EClinicalMedicine. 2021 Jul;37:100981. doi: 10.1016/j.eclinm.2021.100981. Epub 2021 Jun 27. Erratum in: EClinicalMedicine. 2021 Nov;41:101203.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Nitazoxanide
• Other Study ID Numbers: NITFQM0320OR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No