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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.
Full 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.
Enrollment
Sex
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Volunteers
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;
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).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
380 participants in 2 patient groups, including a placebo group
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Central trial contact
Luciana Ferrara; Florentino de Araujo Cardoso Filho, MD, PhD
Data sourced from clinicaltrials.gov
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