Covid19Phase 2FANTAZENCT04918927
Favipiravir +/- Nitazoxanide: Early Antivirals Combination Therapy in COVID-19
A Phase 2 study testing Favipiravir and Nitazoxanide in people with Covid19, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The 2020 pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Covid19
- What is being tested?
- Favipiravir and Nitazoxanide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- 12 Oct 2021to 21 Mar 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Health workers, their household members and, IMSS beneficiaries with the following:
- Symptoms compatible with COVID-19 disease (Fever >37.8oC on at least one occasion AND either cough and/ or anosmia) within the first 5 days of symptom onset (date/time of enrolment must be within the first 5 days of symptom onset)
- OR ANY symptoms compatible with COVID-19 disease (may include, but are not limited to fever, cough, shortness of breath, malaise, myalgia, headache, coryza) and tested positive for SARS-CoV-2 within the first 7 days of symptom onset (date/time of enrolment must be within the first 7 days of symptom onset)
- OR no symptoms but tested positive for SARS-CoV-2 within the last 48 hours (date/time of test must be within 48 hours of enrolment)
- Male or female aged 18 years to 70 years old inclusive at screening
- Willing and able to take daily saliva samples
- Able to provide full informed consent and willing to comply with trial-related procedures
Who cannot join
- Known hypersensitivity to any of the active ingredients or excipients in favipiravir, and in nitazoxanide and matched placebo
- Chronic liver disease at screening (known cirrhosis of any aetiology, chronic hepatitis (e.g. autoimmune, viral, steatohepatitis), cholangitis or any known elevation of liver aminotransferases with AST or ALT > 3 X ULN)*
- Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m2*
- HIV infection, if untreated, detectable viral load or on protease inhibitor therapy
- Any clinical condition which the investigator considers would make the participant unsuitable for the trial
- Concomitant medications known to interact with favipiravir, and with nitazoxanide and matched placebo, and carry risk of toxicity for the participant (See Appendix 4)
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- Current severe illness requiring hospitalisation
- Pregnancy and/ or breastfeeding
- Eligible female participants of childbearing potential and male participants with a partner of childbearing potential not willing to use highly effective contraceptive measures during the trial and within the time point specified following last trial treatment dose.
- Participants enrolled in any other interventional drug or vaccine trial (co-enrolment in observational studies is acceptable).
- Considering the importance of early treatment of COVID-19 to impact viral load, the absence of chronic liver/ kidney disease will be confirmed verbally by the participant during pre- screening and Screening/Baseline visit. Safety blood samples will be collected at Screening/Baseline visit (Day 1) and test results will be examined as soon as they become available within 24 hours.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital de Infectología "Daniel Méndez Hernández" del Centro Médico Nacional La Raza
Mexico City, Azcapotzalco, 02290
About this study
Official title: Favipiravir and/or Nitazoxanide: a Randomized, Double-blind, Placebo-controlled Trial of Early Antiviral Therapy in COVID-19 (FANTAZE)
The 2020 pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with better outcome. The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease.
The plan is to conduct a proof-of-principle placebo-controlled clinical trial of favipiravir plus or minus nitazoxanide in health workers, their household members and IMSS beneficiaries. Participants with or without symptomatic COVID-19 or tested positive will be assigned to receive favipiravir plus nitazoxanide or favipiravir plus nitazoxanide placebo. The primary outcome will be the difference in the amount of virus ('viral load') in the upper respiratory tract after 5 days of therapy. Secondary outcomes will include hospitalization, major morbidity and mortality, pharmacokinetics, and impact of antiviral therapy on viral genetic mutation rate.
If favipiravir with nitazoxanide demonstrates important antiviral effects without significant toxicity, there will be a strong case for a larger trial in people at high risk of hospitalization or intensive care admission, for example older patients and/or those with comorbidities and with early disease.
Read the detailed description
FANTAZE is a Phase IIA randomised, double-blind, placebo-controlled, interventional trial.Participants will be adults who have developed the early symptoms of COVID-19 within the first 5 days, or tested positive for SARS-CoV-2 within the first 7 days of symptom onset, or not presenting symptoms but tested positive within the last 48 hours (date/time of test must be within 48 hours of enrolment).
Eligible participants will be randomised 1:1 to receive one of the following combinations:
Favipiravir + Nitazoxanide (both active); Favipiravir active + Nitazoxanide placebo;
All participants will be enrolled and followed up for 28 days. A saliva sample for virological analysis and safety blood samples will be collected at baseline, as well as a diagnostic nose and throat swab, if the participant hasn't been tested for COVID-19 yet. Following randomisation, participants will take trial medication for 7 days and during this period will take a daily saliva sample and complete a symptoms diary including four daily temperature measurements.
Participants will have two follow-up visits at Day 7 and Day 14 where they will be assessed and undergo blood tests for toxicity and pharmacokinetic assessment (on Day 7 only) and provide stool samples. Participants will have a telephone follow up three (3) weeks after their last day of treatment (Day 7) and further information will be collected through a questionnaire.
- Conditions
- Covid19
- Being tested
- Favipiravir, Nitazoxanide, 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.
FavipiravirDrug
Oral Favipiravir 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7
NitazoxanideDrug
Also called Daxon
Nitazoxanide at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7
Nitazoxanide PlaceboOther
Also called Daxon Placebo
Nitazoxanide matched placebo at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Favipiravir + Nitazoxanide | Experimental | Oral Favipiravir 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Nitazoxanide at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7 Receives: Drug: Favipiravir; Drug: Nitazoxanide |
| Arm 2: Favipiravir + Nitazoxanide placebo | Experimental | Oral favipiravir, 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Nitazoxanide matched placebo at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7. Receives: Drug: Favipiravir; Other: Nitazoxanide Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper respiratory tract viral load at Day 5.
Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy
Measured: Day 5 from randomisation
Secondary outcomes (20)
Percentage of participants with undetectable upper respiratory tract viral load after 5 days of therapy
Method of measurement: quantitative polymerase chain reaction (PCR) performed on saliva samples.
Measured: Day 5 from randomisation
Proportion of participants with undetectable stool viral load after 7 days of therapy and 14 days post-randomisation.
Method of measurement: PCR performed on stool samples
Measured: Day 7 and Day 14 from randomization
Rate of decrease in upper respiratory tract viral load during 7 days of therapy.
Method of measurement: PCR performed on daily saliva samples
Measured: From day of randomisation to day 7
Duration of fever following commencement of medication
Methods of measurement: daily body temperature records between Day 1 and Day 7 post-randomisation
Measured: From day of randomisation to day 7
Proportion of participants with hepatotoxicity after 7day of therapy and 14 days post-randomisation.
Method of measurement: standard diagnostic laboratory assays for liver transaminases, alkaline phosphatase and bilirubin.
Measured: Day 7 and day 14 from randomisation.
Proportion of participants with other medication-related toxicity after 7 days of therapy and 14 days post-randomisation.
Methods of measurement: determination of medication-related adverse events by investigators.
Measured: Day 7 and Day 14 from randomisation.
Proportion of participants admitted to hospital with COVID-19 related illness.
Methods of measurement: participant self-report, review of hospital records and discharge summaries
Measured: 28 days from randomisation.
Proportion of participants admitted to ICU with COVID-19 related illness.
Methods of measurement: participant self-report, review of hospital records and discharge summaries.
Measured: 28 days from randomisation.
Proportion of participants who have died with COVID-19 related illness
Methods of measurement: next of kin report, review of hospital records and discharge summaries.
Measured: 28 days from randomisation.
Pharmacokinetic analysis of favipiravir and tizoxanide: Clearance (CL)
Methods of measurement: assay of favipiravir and tizoxanide levels in plasma at Day 7 of therapy. All participants from each arm will provide a pre-dose sample and two post-dose (30 to 60 min) samples on Day 7 of therapy. A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic data.
The model will estimate the following primary PK parameter: Clearance (CL).
Measured: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Volume of distribution (V)
Methods of measurement: assay of favipiravir and tizoxanide levels in plasma at Day 7 of therapy. All participants from each arm will provide a pre-dose sample and two post-dose (30 to 60 min) samples on Day 7 of therapy. A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic data.
The model will estimate the following primary PK parameter: Volume of distribution (V),
Measured: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Absorption rate constant (Ka)
Methods of measurement: assay of favipiravir and tizoxanide levels in plasma at Day 7 of therapy. All participants from each arm will provide a pre-dose sample and two post-dose (30 to 60 min) samples on Day 7 of therapy. A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic data.
The model will estimate the following primary PK parameter: Absorption rate constant (Ka).
Measured: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Maximum concentration (Cmax)
Methods of measurement: assay of favipiravir and tizoxanide levels in plasma at Day 7 of therapy. All participants from each arm will provide a pre-dose sample and two post-dose (30 to 60 min) samples on Day 7 of therapy. A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic data.
The model will estimate the previous described primary PK parameters from which the following secondary parameter will be derived: Maximum concentration (Cmax),
Measured: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Time to maximum concentration (Tmax)
Methods of measurement: assay of favipiravir and tizoxanide levels in plasma at Day 7 of therapy. All participants from each arm will provide a pre-dose sample and two post-dose (30 to 60 min) samples on Day 7 of therapy. A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic data.
The model will estimate the previous described primary PK parameters from which the following secondary parameter will be derived: Time to maximum concentration (Tmax),
Measured: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Elimination rate constant (Ke)
Methods of measurement: assay of favipiravir and tizoxanide levels in plasma at Day 7 of therapy. All participants from each arm will provide a pre-dose sample and two post-dose (30 to 60 min) samples on Day 7 of therapy. A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic data.
The model will estimate the previous described primary PK parameters from which the following secondary parameter will be derived: Elimination rate constant (Ke),
Measured: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Area Under the Curve extrapolated to infinity (AUC 80-inf).
Methods of measurement: assay of favipiravir and tizoxanide levels in plasma at Day 7 of therapy. All participants from each arm will provide a pre-dose sample and two post-dose (30 to 60 min) samples on Day 7 of therapy. A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic data.
The model will estimate the previous described primary PK parameters from which the following secondary parameter will be derived:
Area Under the Curve extrapolated to infinity (AUC 80-inf)),
Measured: Day 7 from randomization
Pharmacodynamic analysis of favipiravir and tizoxanide: Rate of viral load decline (delta)
A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic and viral load (pharmacodynamic) data.
The model will estimate the following pharmacodynamic parameter: Rate of viral decline (delta) Maximum increase in viral load under drug treatment (Emax), Concentration to achieve half the maximum possible effects (EC50)
Measured: Day 7 from randomization
Pharmacodynamic analysis of favipiravir and tizoxanide: Maximum increase in viral load under drug treatment (Emax).
A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic and viral load (pharmacodynamic) data.
The model will estimate the following pharmacodynamic parameter: Maximum increase in viral load under drug treatment (Emax).
Measured: Day 7 from randomization
Pharmacodynamic analysis of favipiravir and tizoxanide: Concentration to achieve half the maximum possible effects (EC50)
A nonlinear mixed effects model will be fitted jointly to favipiravir and tizoxanide pharmacokinetic and viral load (pharmacodynamic) data.
The model will estimate the following pharmacodynamic parameter: Concentration to achieve half the maximum possible effects (EC50)
Measured: Day 7 from randomization
Exploratory: proportion of participants with deleterious or resistance-conferring mutations in SARS-CoV-2.
Method of measurement: deep sequencing of virus and bioinformatic analysis.
Measured: Day 7 from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start12 Oct 2021
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IIA randomised, double-blind, placebo-controlled, interventional trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Collaborators
- University College, London, Centro de Investigacion y Estudios Avanzados del Instituto Politecnico Nacional (CINVESTAV), Univeridad Autonoma de Guadalajara, Siegfried Rhein S.A. de C.V., Strides Pharma Science Limited, Hakken Enterprise
- Responsible party
- Principal investigator, Jorge Escobedo de la Pena, Coordinación de Investigación en Salud, Mexico
- Investigators
- Jorge Escobedo, Dr., Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918927
- Sponsor's protocol ID
- 2021-785-018
- Acronym
- FANTAZE
- Status last verified
- Mar 2023
- First submitted
- 4 Jun 2021
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No plan to share IPD has been made at this time
Publications
Smith T, Hoyo-Vadillo C, Adom AA, Favari-Perozzi L, Gastine S, Dehbi HM, Villegas-Lara B, Mateos E, Gonzalez YSP, Navarro-Gualito MD, Cruz-Carbajal AS, Cortes-Vazquez MA, Bekker-Mendez C, Aguirre-Alvarado C, Aguirre-Gil G, Delgado-Pastelin L, Owen A, Lowe D, Standing J, Escobedo J. Favipiravir and/or nitazoxanide: a randomized, double-blind, 2x2 design, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE). Trials. 2022 Jul 22;23(1):583. doi: 10.1186/s13063-022-06533-0.
PubMed 35869526
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Favipiravir and/or Nitazoxanide: a Randomized, Double-blind, Placebo-controlled Trial of Early Antiviral Therapy in COVID-19 (FANTAZE)
- ClinicalTrials.gov ID
- NCT04918927
- Acronym / sponsor ID
- FANTAZE / 2021-785-018
- Conditions
- Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Collaborators
- University College, London, Centro de Investigacion y Estudios Avanzados del Instituto Politecnico Nacional (CINVESTAV), Univeridad Autonoma de Guadalajara, Siegfried Rhein S.A. de C.V., Strides Pharma Science Limited, Hakken Enterprise
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 9 Jun 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 2020 pandemic of SARS-CoV-2 causing COVID-19 disease is an unprecedented global emergency. COVID-19 appears to be a disease with an early phase where the virus replicates, coinciding with first presentation of symptoms, followed by a later 'inflammatory' phase which results in severe disease in some individuals. It is known from other rapidly progressive infections such as sepsis and influenza that early treatment with antimicrobials is associated with better outcome. The hypothesis is that this holds for COVID-19 and that early antiviral treatment may prevent progression to the later phase of the disease.
The plan is to conduct a proof-of-principle placebo-controlled clinical trial of favipiravir plus or minus nitazoxanide in health workers, their household members and IMSS beneficiaries. Participants with or without symptomatic COVID-19 or tested positive will be assigned to receive favipiravir plus nitazoxanide or favipiravir plus nitazoxanide placebo. The primary outcome will be the difference in the amount of virus ('viral load') in the upper respiratory tract after 5 days of therapy. Secondary outcomes will include hospitalization, major morbidity and mortality, pharmacokinetics, and impact of antiviral therapy on viral genetic mutation rate.
If favipiravir with nitazoxanide demonstrates important antiviral effects without significant toxicity, there will be a strong case for a larger trial in people at high risk of hospitalization or intensive care admission, for example older patients and/or those with comorbidities and with early disease.
Detailed description
FANTAZE is a Phase IIA randomised, double-blind, placebo-controlled, interventional trial.Participants will be adults who have developed the early symptoms of COVID-19 within the first 5 days, or tested positive for SARS-CoV-2 within the first 7 days of symptom onset, or not presenting symptoms but tested positive within the last 48 hours (date/time of test must be within 48 hours of enrolment).
Eligible participants will be randomised 1:1 to receive one of the following combinations:
Favipiravir + Nitazoxanide (both active); Favipiravir active + Nitazoxanide placebo;
All participants will be enrolled and followed up for 28 days. A saliva sample for virological analysis and safety blood samples will be collected at baseline, as well as a diagnostic nose and throat swab, if the participant hasn't been tested for COVID-19 yet. Following randomisation, participants will take trial medication for 7 days and during this period will take a daily saliva sample and complete a symptoms diary including four daily temperature measurements.
Participants will have two follow-up visits at Day 7 and Day 14 where they will be assessed and undergo blood tests for toxicity and pharmacokinetic assessment (on Day 7 only) and provide stool samples. Participants will have a telephone follow up three (3) weeks after their last day of treatment (Day 7) and further information will be collected through a questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase IIA randomised, double-blind, placebo-controlled, interventional trial.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Favipiravir + Nitazoxanide | Experimental | Drug: Favipiravir, Drug: NitazoxanideOral Favipiravir 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Nitazoxanide at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7 |
| Arm 2: Favipiravir + Nitazoxanide placebo | Experimental | Drug: Favipiravir, Other: Nitazoxanide PlaceboOral favipiravir, 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 PLUS Nitazoxanide matched placebo at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Health workers, their household members and, IMSS beneficiaries with the following:
- Male or female aged 18 years to 70 years old inclusive at screening
- Willing and able to take daily saliva samples
- Able to provide full informed consent and willing to comply with trial-related procedures
Key exclusion criteria (11 listed)
- Known hypersensitivity to any of the active ingredients or excipients in favipiravir, and in nitazoxanide and matched placebo
- Chronic liver disease at screening (known cirrhosis of any aetiology, chronic hepatitis (e.g. autoimmune, viral, steatohepatitis), cholangitis or any known elevation of liver aminotransferases with AST or ALT > 3 X ULN)*
- Chronic kidney disease (stage 3 or beyond) at screening: eGFR < 60 ml/min/1.73m2*
- HIV infection, if untreated, detectable viral load or on protease inhibitor therapy
- Any clinical condition which the investigator considers would make the participant unsuitable for the trial
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 |
|---|---|---|
| FavipiravirOral Favipiravir 1800 mg twice daily on Day 1, followed by 400 mg four (4) times daily from Day 2 to Day 7 | Drug | Arm 1: Favipiravir + Nitazoxanide, Arm 2: Favipiravir + Nitazoxanide placebo |
| NitazoxanideAlso: DaxonNitazoxanide at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7 | Drug | Arm 1: Favipiravir + Nitazoxanide |
| Nitazoxanide PlaceboAlso: Daxon PlaceboNitazoxanide matched placebo at 1000 mg twice daily on Day 1 followed by 500 mg four (4) times daily from Day 2 to Day 7. | Other | Arm 2: Favipiravir + Nitazoxanide placebo |
Primary outcome
Upper respiratory tract viral load at Day 5.
Time frame: Day 5 from randomisation
Quantitative polymerase chain reaction (PCR) performed on saliva samples at Day 5 of therapy
20 secondary outcomes
Percentage of participants with undetectable upper respiratory tract viral load after 5 days of therapy
Time frame: Day 5 from randomisation
Proportion of participants with undetectable stool viral load after 7 days of therapy and 14 days post-randomisation.
Time frame: Day 7 and Day 14 from randomization
Rate of decrease in upper respiratory tract viral load during 7 days of therapy.
Time frame: From day of randomisation to day 7
Duration of fever following commencement of medication
Time frame: From day of randomisation to day 7
Proportion of participants with hepatotoxicity after 7day of therapy and 14 days post-randomisation.
Time frame: Day 7 and day 14 from randomisation.
Proportion of participants with other medication-related toxicity after 7 days of therapy and 14 days post-randomisation.
Time frame: Day 7 and Day 14 from randomisation.
Proportion of participants admitted to hospital with COVID-19 related illness.
Time frame: 28 days from randomisation.
Proportion of participants admitted to ICU with COVID-19 related illness.
Time frame: 28 days from randomisation.
Proportion of participants who have died with COVID-19 related illness
Time frame: 28 days from randomisation.
Pharmacokinetic analysis of favipiravir and tizoxanide: Clearance (CL)
Time frame: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Volume of distribution (V)
Time frame: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Absorption rate constant (Ka)
Time frame: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Maximum concentration (Cmax)
Time frame: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Time to maximum concentration (Tmax)
Time frame: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Elimination rate constant (Ke)
Time frame: Day 7 from randomization
Pharmacokinetic analysis of favipiravir and tizoxanide: Area Under the Curve extrapolated to infinity (AUC 80-inf).
Time frame: Day 7 from randomization
Pharmacodynamic analysis of favipiravir and tizoxanide: Rate of viral load decline (delta)
Time frame: Day 7 from randomization
Pharmacodynamic analysis of favipiravir and tizoxanide: Maximum increase in viral load under drug treatment (Emax).
Time frame: Day 7 from randomization
Pharmacodynamic analysis of favipiravir and tizoxanide: Concentration to achieve half the maximum possible effects (EC50)
Time frame: Day 7 from randomization
Exploratory: proportion of participants with deleterious or resistance-conferring mutations in SARS-CoV-2.
Time frame: Day 7 from randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 35869526Smith T, Hoyo-Vadillo C, Adom AA, Favari-Perozzi L, Gastine S, Dehbi HM, Villegas-Lara B, Mateos E, Gonzalez YSP, Navarro-Gualito MD, Cruz-Carbajal AS, Cortes-Vazquez MA, Bekker-Mendez C, Aguirre-Alvarado C, Aguirre-Gil G, Delgado-Pastelin L, Owen A, Lowe D, Standing J, Escobedo J. Favipiravir and/or nitazoxanide: a randomized, double-blind, 2x2 design, placebo-controlled trial of early therapy in COVID-19 in health workers, their household members, and patients treated at IMSS (FANTAZE). Trials. 2022 Jul 22;23(1):583. doi: 10.1186/s13063-022-06533-0.
- Individual participant dataSharing planned: Undecided. No plan to share IPD has been made at this time
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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.
Jorge Escobedo, Dr. principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Favipiravir and Nitazoxanide in people with Covid19, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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 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: finished, as of the sponsor's last update on 24 Mar 2023. 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 Mexico. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Upper respiratory tract viral load at Day 5. (time frame: Day 5 from randomisation). 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 NCT04918927, which also lists 1 linked publication.
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 24 Mar 2023.