Last updated 2 years ago
Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
380 patients around the world
Available in Brazil
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.
Azidus Brasil
1Research sites
380Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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%;Negative result for pregnancy test (if applicable).
- Participating in another RCT in the past 12 months;Known allergy to nitazoxanideSeverely 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
Hospital Vera Cruz
Recruiting
SponsorAzidus Brasil
Study typeInterventional
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04423861
