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Trial record 1 of 1 for:    NCT04348409
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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

Tracking Information
First Submitted Date  ICMJE April 3, 2020
First Posted Date  ICMJE April 16, 2020
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE May 25, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
Viral load [ Time Frame: day 1, 4, 7, 14 and 21 ]
PCR will be done to evaluate the change in viral load
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2020)
  • Evolution of acute respiratory syndrome [ Time Frame: 21 days ]
    Time to wean off oxygen supplementation
  • 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)
  • Hospital discharge [ Time Frame: 21 days ]
    Time to be discharged from hospital
  • Rate of mortality within 21-days [ Time Frame: 21 days ]
    Evaluation of change in acute respiratory syndrome
  • Need of mechanical ventilation [ Time Frame: 21 days ]
    Evaluation of change in acute respiratory syndrome
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2020)
  • Evolution of acute respiratory syndrome [ Time Frame: 21 days ]
    Time to wean off oxygen supplementation
  • Change in Clinical Condition [ Time Frame: 21 days ]
    WHO ordinal scale that measures illness severity over time
  • Hospital discharge [ Time Frame: 21 days ]
    Time to be discharged from hospital
  • Rate of mortality within 21-days [ Time Frame: 21 days ]
    Evaluation of change in acute respiratory syndrome
  • Need of mechanical ventilation [ Time Frame: 21 days ]
    Evaluation of change in acute respiratory syndrome
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19
Official Title  ICMJE 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.
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Nitazoxanide Tablets
    Patients will receive nitazoxanide 600 mg BID for 7 days
  • Drug: Placebo
    Patients will receive placebo BID for 7 days
Study Arms  ICMJE
  • Experimental: nitazoxanide
    Patients will receive nitazoxanide 600 mg BID for 7 days.
    Intervention: Drug: Nitazoxanide Tablets
  • Placebo Comparator: Placebo
    Patients will receive placebo BID for 7 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04348409
Other Study ID Numbers  ICMJE NITFQM0320OR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Azidus Brasil
Study Sponsor  ICMJE Azidus Brasil
Collaborators  ICMJE
  • 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
Investigators  ICMJE Not Provided
PRS Account Azidus Brasil
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP