Covid19Phase 4PENTZNCT04788407
Efficacy and Safety of Nitazoxanide for Post Exposure Prophylaxis of COVID-19 in Household Contacts
A Phase 4 study testing Nitazoxanide in people with Covid19 and SARS-CoV-2 Infection, run by Fundación Huésped at 1 site in Argentina.
Trial summary
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 500 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in household contacts of patients diagnosed with the disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19, SARS-CoV-2 Infection, Households Contacts
- What is being tested?
- Nitazoxanide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Dec 2020to 30 Apr 2022
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over 18 and under 65.
- Household contact with a confirmed case of COVID-19 by PCR for Sars-CoV-2.
- Initiate study medication within 4 days from the last close contact with the index case.
- The patient must not present symptoms suggestive of Covid19 (cough, dyspnea, fever> 37.5 C, fatigue, sore throat, myalgia, diarrhoea) at the time of admission to the study and from previous 14 days.
- Informed consent from the patient or legal representative.
Who cannot join
- History of infection confirmed by SARS-CoV-2.
- Positive IgG antibodies test for SARS-CoV-2 at the time of admission.
- Have received any dose of nitazoxanide within 7 days prior to screening.
- Known hypersensitivity to any of the study medication components.
- Use of any investigational or unregistered drug or vaccine within 30 days prior to screening, or use planned during the study period.
- Inability to comply with study procedures.
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- Current breastfeeding.
- Pregnancy.
- Intolerance or inability to take oral medication.
- History of severe liver disease (Child-Pugh B or C) and/or chronic kidney disease.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Fundación Huésped.
Buenos Aires, Buenos Aires F.D., C1204
Herman K Ludvik, MD
Omar Sued, MD PhMD
About this study
Official title: Pilot Study of Safety and Efficacy of Nitazoxanide in Post-exposure Prophylaxis in Household Contacts of Patients With Confirmed SARS-CoV-2 Infection
The primary objective of this study is to evaluate the efficacy of the drug nitazoxanide 500 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in household contacts of patients diagnosed with the disease.
Read the detailed description
Eligible participants (cohabitants of a recently confirmed COVID19 case) residing in Buenos Aires City will be identified by the Ministry of Health and contacted with the investigators, who will visit them at home and offer to participate. For consenting individuals, a rapid serological test and a nasopharyngeal PCR sample for SARS-CoV-2 will be performed and participants will be then randomized to NTZ or placebo to be taken during 7 days.
SARS-CoV-2 PCR will be repeated on day 14th and the serologic rapid test repeated on day 28th.
Clinical status of participants will be assessed daily by phone. Individuals meeting case definition will be evaluated at home and a PCR will be performed. Those with confirmed COVID19 case will discontinue study medication and followed until symptoms resolution.
- Conditions
- Covid19, SARS-CoV-2 Infection, Households Contacts
- 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 Nixoran
Subjects will receive nitazoxanide 500 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 nitazoxanide 500 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
Proportion of participants with negative baseline PCR for SARS-CoV-2 who test positive for PCR on day 14 and / or seroconversion on day 28 after initiation of study medication.
Measured: 28 days
Secondary outcomes (2)
Proportion of adverse events (AE) and serious AE (SAE) related to research product.
Safety and adverse events (AEs).
Measured: 28 days
Incidence of all causes of study drug withdrawal or discontinuation.
Treatment adherence.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Dec 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Cluster-Randomized, double-blind, placebo-controlled clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Huésped
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Salud de Ciudad Autónoma de Buenos Aires, Laboratorios Roemmers S.A.I.C.F.
- Responsible party
- Principal investigator, Omar Sued, Fundación Huésped
- Investigators
- Omar Sued, MD PhMD, Study director, Fundacion Huesped.Herman K Ludvik, MD, Principal investigator, Fundación Huésped
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788407
- Sponsor's protocol ID
- FH-53
- Acronym
- PENTZ
- Status last verified
- Jul 2021
- First submitted
- 7 Mar 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: to publish study results
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Safety and Efficacy of Nitazoxanide in Post-exposure Prophylaxis in Household Contacts of Patients With Confirmed SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04788407
- Acronym / sponsor ID
- PENTZ / FH-53
- Conditions
- Covid19, SARS-CoV-2 Infection, Households Contacts
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Fundación HuéspedUniversity, hospital or other
- Collaborators
- Ministerio de Salud de Ciudad Autónoma de Buenos Aires, Laboratorios Roemmers S.A.I.C.F.
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 9 Mar 2021 (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 500 mg, administered three times a day, in relation to placebo in preventing the development of COVID-19 in household contacts of patients diagnosed with the disease.
Detailed description
Eligible participants (cohabitants of a recently confirmed COVID19 case) residing in Buenos Aires City will be identified by the Ministry of Health and contacted with the investigators, who will visit them at home and offer to participate. For consenting individuals, a rapid serological test and a nasopharyngeal PCR sample for SARS-CoV-2 will be performed and participants will be then randomized to NTZ or placebo to be taken during 7 days.
SARS-CoV-2 PCR will be repeated on day 14th and the serologic rapid test repeated on day 28th.
Clinical status of participants will be assessed daily by phone. Individuals meeting case definition will be evaluated at home and a PCR will be performed. Those with confirmed COVID19 case will discontinue study medication and followed until symptoms resolution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, Cluster-Randomized, double-blind, placebo-controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide | Experimental | Drug: NitazoxanideSubjects will receive nitazoxanide 500 mg TID. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects will receive placebo TID. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women over 18 and under 65.
- Household contact with a confirmed case of COVID-19 by PCR for Sars-CoV-2.
- Initiate study medication within 4 days from the last close contact with the index case.
- The patient must not present symptoms suggestive of Covid19 (cough, dyspnea, fever> 37.5 C, fatigue, sore throat, myalgia, diarrhoea) at the time of admission to the study and from previous 14 days.
- Informed consent from the patient or legal representative.
Key exclusion criteria (10 listed)
- History of infection confirmed by SARS-CoV-2.
- Positive IgG antibodies test for SARS-CoV-2 at the time of admission.
- Have received any dose of nitazoxanide within 7 days prior to screening.
- Known hypersensitivity to any of the study medication components.
- Use of any investigational or unregistered drug or vaccine within 30 days prior to screening, or use planned during the study period.
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: NixoranSubjects will receive nitazoxanide 500 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
Proportion of participants with negative baseline PCR for SARS-CoV-2 who test positive for PCR on day 14 and / or seroconversion on day 28 after initiation of study medication.
2 secondary outcomes
Proportion of adverse events (AE) and serious AE (SAE) related to research product.
Time frame: 28 days
Incidence of all causes of study drug withdrawal or discontinuation.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: Yes. to publish study results
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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.
Omar Sued, MD PhMD study director
Fundacion Huesped.
Herman K Ludvik, MD principal investigator
Fundación Huésped
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nitazoxanide in people with Covid19 and SARS-CoV-2 Infection, run by Fundación Huésped at 1 site in Argentina.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar Sued, MD PHd (+54 11 4981-1855/7777 ext. 113, omar.sued@huesped.org.ar), or a site near the patient. 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 2 Jul 2021.