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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: covid19
• Intervention / Treatment: Drug: Nitazoxanide; Drug: Placebo

Detailed Description

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
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: nitazoxanide; Subjects will receive nitazonanide 600 mg TID.	Drug: Nitazoxanide; Subjects will receive nitazonanide 600 mg TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.; Other Names: Viranitta
PLACEBO_COMPARATOR: Placebo; Subjects will receive placebo TID.	Drug: Placebo; Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.

What is the study measuring?

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
Rate of mortality within 21-days	Evaluation of change in acute respiratory syndrome	21 days
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

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Collaborators: Farmoquimica S.A.
• Investigators: Principal Investigator: Edimilson Migowski, MD, NEPS SEMUS Mesquita

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2020
• Study Completion (ANTICIPATED): September 1, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 19, 2020
• First Posted (ACTUAL): June 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Nitazoxanide
• Other Study ID Numbers: NITFQM0720OR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It is believed that after the data analysis and presentation to the National Commission on Research Ethics, all data of the study will become public.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No