Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
Primary Purpose
covid19
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Nitazoxanide
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for covid19
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
nitazoxanide
Placebo
Arm Description
Subjects will receive nitazonanide 600 mg TID.
Subjects will receive placebo TID.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events
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
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
Treatment adherence
Subject adherence to treatment will be assessed through study diary record
Disease complication
Proportion of patients with severe condition
Incidence of subjects that underwent unscheduled visit
Proportion of patient that needed undergo an unscheduled visit
Full Information
NCT ID
NCT04435314
First Posted
June 8, 2020
Last Updated
October 26, 2022
Sponsor
Azidus Brasil
Collaborators
Farmoquimica S.A.
1. Study Identification
Unique Protocol Identification Number
NCT04435314
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor's strategic decision
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
Collaborators
Farmoquimica S.A.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
covid19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nitazoxanide
Arm Type
Experimental
Arm Description
Subjects will receive nitazonanide 600 mg TID.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo TID.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Viranitta
Intervention Description
Subjects will receive nitazonanide 600 mg TID for 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive placebo TID for 7 days.
Primary Outcome Measure Information:
Title
The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
Description
PCR will be done to evaluate infection
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
Number of participants with treatment-related adverse events
Time Frame
28 days
Title
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
Description
Symptomatic PCR positive subjects
Time Frame
28 days
Title
The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study
Description
Asymptomatic PCR will be done to evaluate infection
Time Frame
28 days
Title
Treatment adherence
Description
Subject adherence to treatment will be assessed through study diary record
Time Frame
7 days
Title
Disease complication
Description
Proportion of patients with severe condition
Time Frame
28 days
Title
Incidence of subjects that underwent unscheduled visit
Description
Proportion of patient that needed undergo an unscheduled visit
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reginaldo Raimundo Fujita
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
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