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
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.

Recruiting
COVID19

Drug: Nitazoxanide

Patients will receive nitazoxanide 600 mg BID for 7 days.
Other Name: Viranitta (Nitazoxanide)

Drug: Placebo

Patients will receive matching placebo BID for 7 days.

Eligibility Criteria

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%;

7. 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Brazil
Locations

Hospital Vera Cruz
Campinas, São Paulo, Brazil

Investigator: Florentino de Araujo Cardoso Filho, MD, PhD
Contact: +55 19 991232882
florentino.cardoso@hospitalcare.com.br

Contacts

Florentino de Araujo Cardoso Filho, MD, PhD
+55 19 991232882
florentino.cardoso@hospitalcare.com.br

Luciana Ferrara
+55 19 981428814
luciana.ferrara@azidusbrasil.com.br

Florentino de Araujo Cardoso Filho, MD, PhD, Principal Investigator
+55 19 991232882

Farmoquimica S.A.
NCT Number
MeSH Terms
COVID-19
Nitazoxanide