covid19Phase 2NCT04435314
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19
A Phase 2 study testing Nitazoxanide in people with covid19, run by Azidus Brasil.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- covid19
- What is being tested?
- Nitazoxanide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Aug 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- covid19
- Being tested
- Nitazoxanide, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called Viranitta
Subjects will receive nitazonanide 600 mg TID for 7 days
PlaceboDrug
Subjects will receive placebo TID for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| nitazoxanide | Experimental | Subjects will receive nitazonanide 600 mg TID. Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | Subjects will receive placebo TID. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (6)
Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events
Measured: 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
Measured: 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
Measured: 28 days
Treatment adherence
Subject adherence to treatment will be assessed through study diary record
Measured: 7 days
Disease complication
Proportion of patients with severe condition
Measured: 28 days
Incidence of subjects that underwent unscheduled visit
Proportion of patient that needed undergo an unscheduled visit
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: Sponsor's strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Farmoquimica S.A.
- Responsible party
- Sponsor
- Investigators
- Reginaldo Raimundo Fujita, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435314
- Sponsor's protocol ID
- NITFQM0620OR
- Status last verified
- Oct 2022
- First submitted
- 8 Jun 2020
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04435314
- Acronym / sponsor ID
- NITFQM0620OR
- Conditions
- covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor's strategic decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Collaborators
- Farmoquimica S.A.
- Study start
- Jun 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized to receive either nitazoxanide (n=100) or placebo (n=100)
| Arm | Type | Receives |
|---|---|---|
| nitazoxanide | Experimental | Drug: NitazoxanideSubjects will receive nitazonanide 600 mg TID. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo TID. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideAlso: ViranittaSubjects will receive nitazonanide 600 mg TID for 7 days | Drug | nitazoxanide |
| PlaceboSubjects will receive placebo TID for 7 days. | Drug | Placebo |
Primary outcome
The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
Time frame: 28 days
PCR will be done to evaluate infection
6 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 28 days
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study
Time frame: 28 days
The proportion of subjects with asymptomatic laboratory-confirmed COVID identified after the start of treatment and before the end of the study
Time frame: 28 days
Treatment adherence
Time frame: 7 days
Disease complication
Time frame: 28 days
Incidence of subjects that underwent unscheduled visit
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reginaldo Raimundo Fujita principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide in people with covid19, run by Azidus Brasil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with laboratory-confirmed COVID-19 identified after start of treatment and before the end of the study (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.