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

Sponsor
Azidus Brasil (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT04423861
Collaborator
Farmoquimica S.A. (Industry), Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil (Other)
380
2
5

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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)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
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

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 Names:
  • Viranitta
  • Placebo Comparator: Placebo

    Patients will receive matching placebo BID for 7 days.

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change in the pulmonary condition [Baseline, Day 7 and Day 14]

      Evaluation of change in oximetry, respiratory rate and need for oxygen therapy

    2. 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

    3. Change in tomographic pulmonary condition [Baseline, Day 7]

      Evaluation of change in chest CT

    4. Rate of mortality within 14-days [14 days]

      Evaluation of change in acute respiratory syndrome

    5. Change in inflammatory markers [Baseine, Day 7, Day 14]

      Evaluation of change in inflammatory markers d-dimer and IL-6

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Azidus Brasil
    • Farmoquimica S.A.
    • Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Azidus Brasil
    ClinicalTrials.gov Identifier:
    NCT04423861
    Other Study ID Numbers:
    • NITFQM0920OR-III
    First Posted:
    Jun 9, 2020
    Last Update Posted:
    Nov 27, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 27, 2020