Back to resultsEfficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
Primary Purpose
covid19
Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for covid19
Eligibility Criteria
Inclusion Criteria:
- Informed consent from patient or legal representative.
- Male or female, aged ≥ 18 years;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase
- chain reaction (RT-PCR) from any diagnostic sampling source;
- 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:
- Participating in another RCT in the past 12 months;
- Known allergy to nitazoxanide
- Severely reduced LV function;
- Severely reduced renal function;
- Pregnancy or breast feeding;
- Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);
- History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;
- Ongoing antineoplastic treatment with chemotherapy or radiation therapy;
- Diagnose of severe autoimmune diseases in immunosuppression;
- Transplanted patients;
- 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
Sites / Locations
- Hospital Vera CruzRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
nitazoxanide BID
Placebo
Arm Description
Patients will receive nitazoxanide 600 mg BID for 7 days.
Patients will receive matching placebo BID for 7 days.
Outcomes
Primary Outcome Measures
Need of mechanical ventilation
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
Change in the pulmonary condition
Evaluation of change in oximetry, respiratory rate and need for oxygen therapy
Change in Clinical Condition
Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction
Change in tomographic pulmonary condition
Evaluation of change in chest CT
Rate of mortality within 14-days
Evaluation of change in acute respiratory syndrome
Change in inflammatory markers
Evaluation of change in inflammatory markers d-dimer and IL-6
Full Information
NCT ID
NCT04423861
First Posted
June 8, 2020
Last Updated
October 27, 2022
Sponsor
Azidus Brasil
Collaborators
Farmoquimica S.A.
1. Study Identification
Unique Protocol Identification Number
NCT04423861
Brief Title
Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
Collaborators
Farmoquimica S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to receive either nitazoxanide 600 mg BID or Placebo (1:1)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nitazoxanide BID
Arm Type
Experimental
Arm Description
Patients will receive nitazoxanide 600 mg BID for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive matching placebo BID for 7 days.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Viranitta (Nitazoxanide)
Intervention Description
Patients will receive nitazoxanide 600 mg BID for 7 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive matching placebo BID for 7 days.
Primary Outcome Measure Information:
Title
Need of mechanical ventilation
Description
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)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change in the pulmonary condition
Description
Evaluation of change in oximetry, respiratory rate and need for oxygen therapy
Time Frame
Baseline, Day 7 and Day 14
Title
Change in Clinical Condition
Description
Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction
Time Frame
Baseline, Day 7 and Day 14
Title
Change in tomographic pulmonary condition
Description
Evaluation of change in chest CT
Time Frame
Baseline, Day 7
Title
Rate of mortality within 14-days
Description
Evaluation of change in acute respiratory syndrome
Time Frame
14 days
Title
Change in inflammatory markers
Description
Evaluation of change in inflammatory markers d-dimer and IL-6
Time Frame
Baseine, Day 7, Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed consent from patient or legal representative.
Male or female, aged ≥ 18 years;
Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase
chain reaction (RT-PCR) from any diagnostic sampling source;
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:
Participating in another RCT in the past 12 months;
Known allergy to nitazoxanide
Severely reduced LV function;
Severely reduced renal function;
Pregnancy or breast feeding;
Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);
History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;
Ongoing antineoplastic treatment with chemotherapy or radiation therapy;
Diagnose of severe autoimmune diseases in immunosuppression;
Transplanted patients;
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Florentino de Araujo Cardoso Filho, MD, PhD
Phone
+55 19 991232882
Email
florentino.cardoso@hospitalcare.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana Ferrara
Phone
+55 19 981428814
Email
luciana.ferrara@azidusbrasil.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florentino de Araujo Cardoso Filho, MD, PhD
Organizational Affiliation
+55 19 991232882
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Vera Cruz
City
Campinas
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florentino de Araujo Cardoso Filho, MD, PhD
Phone
+55 19 991232882
Email
florentino.cardoso@hospitalcare.com.br
First Name & Middle Initial & Last Name & Degree
Luciana Ferrara
Phone
+55 19 981428814
Email
luciana.ferrara@azidusbrasil.com.br
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
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