Clinical trial NCT04435314: Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: covid19
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Farmoquimica S.A.
First posted: 2020-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
timeFrame: 28 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 28 days
measure: The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
timeFrame: 28 days
measure: The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study
timeFrame: 28 days
measure: Treatment adherence
timeFrame: 7 days
measure: Disease complication
timeFrame: 28 days
measure: Incidence of subjects that underwent unscheduled visit
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Reginaldo Raimundo Fujita
role: PRINCIPAL_INVESTIGATOR
References: