Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19

Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg Three Times a Day for Post Exposure Prophylaxis of COVID-19 in Subjects From Vulnerable Communities

The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.

Study Overview

• Status: Withdrawn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

Detailed Description

The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 600 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in subjects from vulnerable communities that had direct contact with patients diagnosed with the disease.

Subjects that PCR is negative after having direct contact with symptomatic subjects and diagnosed with COVID-19 (PCR positive) will be randomized to receive Nitazoxanide TID or placebo TID for 7 days.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 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 18 years or over;
• Subject that lives in a vulnerable community;
• Subject that were in direct contact with confirmed cases of SARS-CoV-2 infection, as they live or work directly with index patients;
• Not showing symptoms compatible with COVID-19 and and that do not have a positive RT-PCR test in a nasopharyngeal swab sample before randomization;
• Participant capable of understanding and fulfilling all activities planned for the study;
• In use of an acceptable method of contraception throughout the study.

Exclusion Criteria:

• Participating in another RCT in the past 12 months;
• Positive PCR result for COVID-19 during screening;
• History of infection confirmed by SARS-CoV-2;
• Present symptoms suggestive of SARS-CoV-2 infection;

• 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 antivirals and / or antiparasitic drugs in the last 30 days;
• 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: PREVENTION
• 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; Other Names: Viranitta
PLACEBO_COMPARATOR: Placebo; Subjects will receive placebo TID.	Drug: Placebo; Subjects will receive placebo TID for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study	PCR will be done to evaluate infection	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Number of participants with treatment-related adverse events	28 days
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study	Symptomatic PCR positive subjects	28 days
The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study	Asymptomatic PCR will be done to evaluate infection	28 days
Treatment adherence	Subject adherence to treatment will be assessed through study diary record	7 days
Disease complication	Proportion of patients with severe condition	28 days
Incidence of subjects that underwent unscheduled visit	Proportion of patient that needed undergo an unscheduled visit	28 days

Collaborators and Investigators

• Sponsor: Azidus Brasil
• Collaborators: Farmoquimica S.A.
• Investigators: Principal Investigator: Reginaldo Raimundo Fujita, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (ACTUAL): June 17, 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: NITFQM0620OR

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