Back to resultsEfficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nitazoxanide Tablets
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
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;
- Signs of respiratory failure requiring oxygen therapy
- Hospitalized for up to 36h with non-invasive ventilation
- 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;
- Use of hydroxychloroquine and/or azithromycin in the past 15 days;
- 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 Cruz
- Centro de Genomas
- Hospital Emílio Ribas
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
nitazoxanide
Placebo
Arm Description
Patients will receive nitazoxanide 600 mg BID for 7 days.
Patients will receive placebo BID for 7 days
Outcomes
Primary Outcome Measures
Viral load
PCR will be done to evaluate the change in viral load
Secondary Outcome Measures
Evolution of acute respiratory syndrome
Time to wean off oxygen supplementation
Change in Clinical Condition
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 to be discharged from hospital
Rate of mortality within 21-days
Evaluation of change in acute respiratory syndrome
Need of mechanical ventilation
Evaluation of change in acute respiratory syndrome
Full Information
NCT ID
NCT04348409
First Posted
April 3, 2020
Last Updated
October 26, 2022
Sponsor
Azidus Brasil
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
1. Study Identification
Unique Protocol Identification Number
NCT04348409
Brief Title
Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
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
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to receive either nitazoxanide or placebo (1:1).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nitazoxanide
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 placebo BID for 7 days
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide Tablets
Intervention Description
Patients will receive nitazoxanide 600 mg BID for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo BID for 7 days
Primary Outcome Measure Information:
Title
Viral load
Description
PCR will be done to evaluate the change in viral load
Time Frame
day 1, 4, 7, 14 and 21
Secondary Outcome Measure Information:
Title
Evolution of acute respiratory syndrome
Description
Time to wean off oxygen supplementation
Time Frame
21 days
Title
Change in Clinical Condition
Description
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
21 days
Title
Hospital discharge
Description
Time to be discharged from hospital
Time Frame
21 days
Title
Rate of mortality within 21-days
Description
Evaluation of change in acute respiratory syndrome
Time Frame
21 days
Title
Need of mechanical ventilation
Description
Evaluation of change in acute respiratory syndrome
Time Frame
21 days
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;
Signs of respiratory failure requiring oxygen therapy
Hospitalized for up to 36h with non-invasive ventilation
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;
Use of hydroxychloroquine and/or azithromycin in the past 15 days;
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
Facility Information:
Facility Name
Hospital Vera Cruz
City
Campinas
State/Province
São Paulo
Country
Brazil
Facility Name
Centro de Genomas
City
São Paulo
Country
Brazil
Facility Name
Hospital Emílio Ribas
City
São Paulo
Country
Brazil
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.
Citations:
PubMed Identifier
34222847
Citation
Blum VF, Cimerman S, Hunter JR, Tierno P, Lacerda A, Soeiro A, Cardoso F, Bellei NC, Maricato J, Mantovani N, Vassao M, Dias D, Galinskas J, Janini LMR, Santos-Oliveira JR, Da-Cruz AM, Diaz RS. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial. EClinicalMedicine. 2021 Jul;37:100981. doi: 10.1016/j.eclinm.2021.100981. Epub 2021 Jun 27. Erratum In: EClinicalMedicine. 2021 Nov;41:101203.
Results Reference
derived
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Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19
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