covid19Phase 2/3NCT04441398

Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients

A Phase 2/3 study testing Nitazoxanide in people with covid19, run by Azidus Brasil.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only. Read more about this study

Who is it for?: Ages 50 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: Jul 2020to Sep 2020
Phase: Phase 2/3
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 50 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 over 49;
Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and:
Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.

Who cannot join

Participating in another RCT in the past 12 months;
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;

Show all 14Show fewer

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 other antiviral drugs;
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 to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita

Read the detailed description

After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.

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. Treatment can be extended for another 7 days at Investigators discretion.
PlaceboDrug
Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.

Study groups in NCT04441398
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.

Change in signs and symptoms scale
Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).
Measured: 21 days

Secondary outcomes (5)

Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events
Measured: 21 days
The proportion of subjects hospitalized after start of treatment and before the end of the study
Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
Measured: 21 days
The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study
Change in clinical condition - WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)
Measured: 21 days
Duration of symptoms
Time required (days) to full symptom recovery
Measured: 21 days
Rate of mortality within 21-days
Evaluation of change in acute respiratory syndrome
Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2020Sep 2020

First posted22 Jun 2020
Study startJul 2020 (estimated)
Primary completionSep 2020 (estimated)
Study completionSep 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Subjects will be randomized to receive either nitazoxanide (n=150) or placebo (n=150)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04441398
Sponsor's protocol ID: NITFQM0720OR
Status last verified: Oct 2022
First submitted: 18 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All covid19 trials

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 to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita
ClinicalTrials.gov ID: NCT04441398
Acronym / sponsor ID: NITFQM0720OR
Conditions: covid19
Phase: Phase 2/3
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: Jul 2020 (estimated)
Primary completion: Sep 2020 (estimated)
Study completion: Sep 2020 (estimated)
First posted: 22 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.

Detailed description

After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.

Study design

Primary purpose: Treatment
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=150) or placebo (n=150)

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: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Informed consent from patient or legal representative.
Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49;
Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and:

Key exclusion criteria (14 listed)

Participating in another RCT in the past 12 months;
Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:
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 other antiviral drugs;

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. Treatment can be extended for another 7 days at Investigators discretion.	Drug	nitazoxanide
PlaceboSubjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.	Drug	Placebo

Primary outcome

Change in signs and symptoms scale
Time frame: 21 days
Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).

5 secondary outcomes

Incidence of Treatment-Emergent Adverse Events
Time frame: 21 days
The proportion of subjects hospitalized after start of treatment and before the end of the study
Time frame: 21 days
The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study
Time frame: 21 days
Duration of symptoms
Time frame: 21 days
Rate of mortality within 21-days
Time frame: 21 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.

Related trials for covid19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
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Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
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Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
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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.

Edimilson Migowski, MD principal investigator

NEPS SEMUS Mesquita

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 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 5 inclusion and 14 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Change in signs and symptoms scale (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04441398.

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.