Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita

Conditions
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covid19

Intervention / Treatment
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* Drug: Nitazoxanide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent from patient or legal representative. Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49; Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and: i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health. Exclusion Criteria: Participating in another RCT in the past 12 months; Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to: HIV or HTLV virus infection; Chronic hepatitis C (HCV) treated with direct antiviral drugs; Liver failure; Severe renal failure, including dialysis; Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds; Concomitant administration of drugs that may interact with the product under study (nitazoxanide); Participants who underwent treatment with other antiviral drugs; Subject in antineoplastic treatment with chemotherapy or radiation therapy; Subject with severe autoimmune diseases in immunosuppression; Transplanted participants; Pregnant or lactating women; Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Subjects will be randomized to receive either nitazoxanide (n=150) or placebo (n=150)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nitazoxanide<br>Subjects will receive nitazonanide 600 mg TID. | Drug: Nitazoxanide<br>* Subjects will receive nitazonanide 600 mg TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.<br>* Other names: Viranitta;|
| Placebo Comparator: Placebo<br>Subjects will receive placebo TID. | Drug: Placebo<br>* Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Number of participants with treatment-related adverse events | 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) | 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) | 21 days | 
| Duration of symptoms | Time required (days) to full symptom recovery | 21 days | 
| Rate of mortality within 21-days | Evaluation of change in acute respiratory syndrome | 21 days |