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

NCT04435314 | Withdrawn Phase 2

• 1 other identifier: NITFQM0620OR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Incidence of Treatment-Emergent 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

  28 days

• The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study

  28 days

• Treatment adherence

  7 days

• Disease complication

  28 days

Study Arms (2)

nitazoxanide

EXPERIMENTAL

Subjects will receive nitazonanide 600 mg TID.

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo TID.

Drug: Placebo

Interventions

Nitazoxanide DRUG

Subjects will receive nitazonanide 600 mg TID for 7 days

Also known as: Viranitta

nitazoxanide

Placebo DRUG

Subjects will receive placebo TID for 7 days.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Azidus Brasil: lead
• Farmoquimica S.A.: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Reginaldo Raimundo Fujita

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 17, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share