Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

Study Overview
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Brief Summary
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This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

Detailed Description
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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.

Official Title
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Proof of Concept, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Safety and Efficacy of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Moderate Condition.

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Nitazoxanide Tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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; Signs of respiratory failure requiring oxygen therapy Hospitalized for up to 36h with non-invasive ventilation Negative result for pregnancy test (if applicable). Exclusion Criteria: Participating in another RCT in the past 12 months; Known allergy to nitazoxanide Severely reduced LV function; Severely reduced renal function; Pregnancy or breast feeding; Use of hydroxychloroquine and/or azithromycin in the past 15 days; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to receive either nitazoxanide or placebo (1:1).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nitazoxanide<br>Patients will receive nitazoxanide 600 mg BID for 7 days. | Drug: Nitazoxanide Tablets<br>* Patients will receive nitazoxanide 600 mg BID for 7 days<br>|
| Placebo Comparator: Placebo<br>Patients will receive placebo BID for 7 days | Drug: Placebo<br>* Patients will receive placebo BID for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load | PCR will be done to evaluate the change in viral load | day 1, 4, 7, 14 and 21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of acute respiratory syndrome | Time to wean off oxygen supplementation | 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) | 21 days | 
| Hospital discharge | Time to be discharged from hospital | 21 days | 
| Rate of mortality within 21-days | Evaluation of change in acute respiratory syndrome | 21 days | 
| Need of mechanical ventilation | Evaluation of change in acute respiratory syndrome | 21 days |