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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
380
Patients will receive nitazoxanide 600 mg BID for 7 days.
Patients will receive matching placebo BID for 7 days.
Hospital Vera Cruz
Campinas, São Paulo, Brazil
RECRUITINGNeed of mechanical ventilation
Evaluation of change in acute respiratory syndrome using 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: 14 days
Change in the pulmonary condition
Evaluation of change in oximetry, respiratory rate and need for oxygen therapy
Time frame: Baseline, Day 7 and Day 14
Change in Clinical Condition
Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction
Time frame: Baseline, Day 7 and Day 14
Change in tomographic pulmonary condition
Evaluation of change in chest CT
Time frame: Baseline, Day 7
Rate of mortality within 14-days
Evaluation of change in acute respiratory syndrome
Time frame: 14 days
Change in inflammatory markers
Evaluation of change in inflammatory markers d-dimer and IL-6
Time frame: Baseine, Day 7, Day 14
Florentino de Araujo Cardoso Filho, MD, PhD
CONTACT
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