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

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ClinicalTrials.gov Identifier: NCT04348409
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : June 9, 2020
Sponsor:
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
Information provided by (Responsible Party):
Azidus Brasil

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Nitazoxanide Tablets Drug: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either nitazoxanide or placebo (1:1).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Viral load [ Time Frame: day 1, 4, 7, 14 and 21 ]
    PCR will be done to evaluate the change in viral load


Secondary Outcome Measures :
  1. Evolution of acute respiratory syndrome [ Time Frame: 21 days ]
    Time to wean off oxygen supplementation

  2. Change in Clinical Condition [ Time Frame: 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)

  3. Hospital discharge [ Time Frame: 21 days ]
    Time to be discharged from hospital

  4. Rate of mortality within 21-days [ Time Frame: 21 days ]
    Evaluation of change in acute respiratory syndrome

  5. Need of mechanical ventilation [ Time Frame: 21 days ]
    Evaluation of change in acute respiratory syndrome


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348409


Contacts
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Contact: Florentino de Araujo Cardoso Filho, MD, PhD +55 19 991232882 florentino.cardoso@hospitalcare.com.br
Contact: Luciana Ferrara +55 19 981428814 luciana.ferrara@azidusbrasil.com.br

Locations
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Brazil
Hospital Vera Cruz Recruiting
Campinas, São Paulo, Brazil
Contact: Florentino de Araujo Cardoso Filho       florentino.cardoso@hospitalcare.com.br   
Centro de Genomas Recruiting
São Paulo, Brazil
Contact: Ricardo Diaz, MD, PhD    +55 11 991090445    rsdiaz@catg.om.br   
Hospital Emílio Ribas Recruiting
São Paulo, Brazil
Contact: Sérgio Cimerman, MD, PhD    +55 11 98377-7272    scimerman@uol.com.br   
Sponsors and Collaborators
Azidus Brasil
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT04348409    
Other Study ID Numbers: NITFQM0320OR
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents