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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04423861
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : November 27, 2020
Sponsor:
Collaborators:
Farmoquimica S.A.
Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
covid19 Drug: Nitazoxanide Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either nitazoxanide 600 mg BID or Placebo (1:1)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: nitazoxanide BID
Patients will receive nitazoxanide 600 mg BID for 7 days.
Drug: Nitazoxanide
Patients will receive nitazoxanide 600 mg BID for 7 days.
Other Name: Viranitta

Placebo Comparator: Placebo
Patients will receive matching placebo BID for 7 days.
Drug: Placebo
Patients will receive matching placebo BID for 7 days.




Primary Outcome Measures :
  1. Need of mechanical ventilation [ Time Frame: 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 :
  1. Change in the pulmonary condition [ Time Frame: Baseline, Day 7 and Day 14 ]
    Evaluation of change in oximetry, respiratory rate and need for oxygen therapy

  2. Change in Clinical Condition [ Time Frame: Baseline, Day 7 and Day 14 ]
    Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction

  3. Change in tomographic pulmonary condition [ Time Frame: Baseline, Day 7 ]
    Evaluation of change in chest CT

  4. Rate of mortality within 14-days [ Time Frame: 14 days ]
    Evaluation of change in acute respiratory syndrome

  5. Change in inflammatory markers [ Time Frame: Baseine, Day 7, Day 14 ]
    Evaluation of change in inflammatory markers d-dimer and IL-6



Information from the National Library of Medicine

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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
  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

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): NCT04423861


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

Sponsors and Collaborators
Azidus Brasil
Farmoquimica S.A.
Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil
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Responsible Party: Azidus Brasil
ClinicalTrials.gov Identifier: NCT04423861    
Other Study ID Numbers: NITFQM0920OR-III
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: October 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