The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.
The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only. After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Subjects will receive nitazonanide 600 mg TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
Change in signs and symptoms scale
Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).
Time frame: 21 days
Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events
Time frame: 21 days
The proportion of subjects hospitalized after start of treatment and before the end of the study
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
The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study
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
Duration of symptoms
Time required (days) to full symptom recovery
Time frame: 21 days
Rate of mortality within 21-days
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Evaluation of change in acute respiratory syndrome
Time frame: 21 days