This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.
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 complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide for 7 days on top of standard care compared to patients who receive standard care and placebo. Patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Patients will receive nitazoxanide 600 mg BID for 7 days
Patients will receive placebo BID for 7 days
Hospital Vera Cruz
Campinas, São Paulo, Brazil
Centro de Genomas
São Paulo, Brazil
Hospital Emílio Ribas
São Paulo, Brazil
Viral load
PCR will be done to evaluate the change in viral load
Time frame: day 1, 4, 7, 14 and 21
Evolution of acute respiratory syndrome
Time to wean off oxygen supplementation
Time frame: 21 days
Change in Clinical Condition
WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
Time frame: 21 days
Hospital discharge
Time to be discharged from hospital
Time frame: 21 days
Rate of mortality within 21-days
Evaluation of change in acute respiratory syndrome
Time frame: 21 days
Need of mechanical ventilation
Evaluation of change in acute respiratory syndrome
Time frame: 21 days
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