Status:
UNKNOWN
Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
Farmoquimica S.A.
Conditions:
covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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;
- 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
- 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
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT04423861
Start Date
June 22 2022
End Date
March 1 2023
Last Update
October 31 2022
Active Locations (1)
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1
Hospital Vera Cruz
Campinas, São Paulo, Brazil