covid19Phase 3NCT04423861
Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
A Phase 3 study testing Nitazoxanide in people with covid19, run by Azidus Brasil at 1 site in Brazil.
Trial summary
This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 380 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Jun 2022to Mar 2023
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent from patient or legal representative.
- Male or female, aged ≥ 18 years;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase
- chain reaction (RT-PCR) from any diagnostic sampling source;
- Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation <98%;
- 7. Negative result for pregnancy test (if applicable).
Who cannot join
- Participating in another RCT in the past 12 months;
- Known allergy to nitazoxanide
- Severely reduced LV function;
- Severely reduced renal function;
- Pregnancy or breast feeding;
- Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);
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- History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;
- Ongoing antineoplastic treatment with chemotherapy or radiation therapy;
- Diagnose of severe autoimmune diseases in immunosuppression;
- Transplanted patients;
- Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
Trial locations and contacts
1 site in 1 country.
Florentino de Araujo Cardoso Filho, MD, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital Vera Cruz
Campinas, São Paulo
Florentino de Araujo Cardoso Filho, MD, PhD, +55 19 991232882, florentino.cardoso@hospitalcare.com.br
Luciana Ferrara, +55 19 981428814, luciana.ferrara@azidusbrasil.com.br
About this study
Official title: A Phase III, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Non-critical Condition
This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.
Read the detailed description
This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.
The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care..
Therefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.
- 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 (Nitazoxanide)
Patients will receive nitazoxanide 600 mg BID for 7 days.
PlaceboDrug
Patients will receive matching placebo BID for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| nitazoxanide BID | Experimental | Patients will receive nitazoxanide 600 mg BID for 7 days. Receives: Drug: Nitazoxanide |
| Placebo | Placebo comparator | Patients will receive matching placebo BID for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need of mechanical ventilation
Evaluation of change in acute respiratory syndrome using 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: 14 days
Secondary outcomes (5)
Change in the pulmonary condition
Evaluation of change in oximetry, respiratory rate and need for oxygen therapy
Measured: Baseline, Day 7 and Day 14
Change in Clinical Condition
Evaluation of change in the following symptoms: cough, headache, myalgia and fever, level of consciousness and organ dysfunction
Measured: Baseline, Day 7 and Day 14
Change in tomographic pulmonary condition
Evaluation of change in chest CT
Measured: Baseline, Day 7
Rate of mortality within 14-days
Evaluation of change in acute respiratory syndrome
Measured: 14 days
Change in inflammatory markers
Evaluation of change in inflammatory markers d-dimer and IL-6
Measured: Baseine, Day 7, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start22 Jun 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive either nitazoxanide 600 mg BID or Placebo (1:1)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azidus Brasil
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Farmoquimica S.A.
- Responsible party
- Sponsor
- Investigators
- Florentino de Araujo Cardoso Filho, MD, PhD, Principal investigator, +55 19 991232882
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423861
- Sponsor's protocol ID
- NITFQM0920OR-III
- Status last verified
- Oct 2022
- First submitted
- 8 Jun 2020
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Non-critical Condition
- ClinicalTrials.gov ID
- NCT04423861
- Acronym / sponsor ID
- NITFQM0920OR-III
- Conditions
- covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Azidus BrasilIndustry (pharma, biotech, devices)
- Collaborators
- Farmoquimica S.A.
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 9 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.
This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.
Detailed description
This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.
The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care..
Therefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.
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
- Patients will be randomized to receive either nitazoxanide 600 mg BID or Placebo (1:1)
| Arm | Type | Receives |
|---|---|---|
| nitazoxanide BID | Experimental | Drug: NitazoxanidePatients will receive nitazoxanide 600 mg BID for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive matching placebo BID for 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed consent from patient or legal representative.
- Male or female, aged ≥ 18 years;
- Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase
- chain reaction (RT-PCR) from any diagnostic sampling source;
- Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation <98%;
Key exclusion criteria (11 listed)
- Participating in another RCT in the past 12 months;
- Known allergy to nitazoxanide
- Severely reduced LV function;
- Severely reduced renal function;
- Pregnancy or breast feeding;
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: Viranitta (Nitazoxanide)Patients will receive nitazoxanide 600 mg BID for 7 days. | Drug | nitazoxanide BID |
| PlaceboPatients will receive matching placebo BID for 7 days. | Drug | Placebo |
Primary outcome
Need of mechanical ventilation
Time frame: 14 days
Evaluation of change in acute respiratory syndrome using 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)
5 secondary outcomes
Change in the pulmonary condition
Time frame: Baseline, Day 7 and Day 14
Change in Clinical Condition
Time frame: Baseline, Day 7 and Day 14
Change in tomographic pulmonary condition
Time frame: Baseline, Day 7
Rate of mortality within 14-days
Time frame: 14 days
Change in inflammatory markers
Time frame: Baseine, Day 7, Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: Undecided. 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.
Florentino de Araujo Cardoso Filho, MD, PhD contact
Florentino de Araujo Cardoso Filho, MD, PhD principal investigator
+55 19 991232882
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitazoxanide in people with covid19, run by Azidus Brasil at 1 site in Brazil.
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 6 inclusion and 11 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 31 Oct 2022. 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 Brazil. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florentino de Araujo Cardoso Filho, MD, PhD (+55 19 991232882, florentino.cardoso@hospitalcare.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need of mechanical ventilation (time frame: 14 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 31 Oct 2022.