Status:
COMPLETED
Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
Farmoquimica S.A.
Hospital Vera Cruz
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04348409
Start Date
May 25 2020
End Date
December 31 2020
Last Update
October 28 2022
Active Locations (3)
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1
Hospital Vera Cruz
Campinas, São Paulo, Brazil
2
Centro de Genomas
São Paulo, Brazil
3
Hospital Emílio Ribas
São Paulo, Brazil