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

covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04435314
• Other study ID #: NITFQM0620OR
• Status: Withdrawn
• Phase: Phase 2
• Start date: June 2020
• Est. completion date: August 2020

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• covid19

Intervention

Drug:
• Nitazoxanide
Subjects will receive nitazonanide 600 mg TID for 7 days
• Placebo
Subjects will receive placebo TID for 7 days.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Azidus Brasil	Farmoquimica S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Treatment-Emergent Adverse Events	Number of participants with treatment-related adverse events	28 days
Secondary	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
Secondary	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
Secondary	Treatment adherence	Subject adherence to treatment will be assessed through study diary record	7 days
Secondary	Disease complication	Proportion of patients with severe condition	28 days
Secondary	Incidence of subjects that underwent unscheduled visit	Proportion of patient that needed undergo an unscheduled visit	28 days