Covid-19Phase 2NACOVIDNCT04459286
The Nitazoxanide Plus Atazanavir for COVID-19 Study
A Phase 2 study testing Nitazoxanide and atazanavir/ritonavir in people with Covid-19, run by Obafemi Awolowo University at 2 sites in Nigeria.
Trial summary
Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid-19
- What is being tested?
- Nitazoxanide and atazanavir/ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesNigeria
- Study dates
- 9 Oct 2020to 2 May 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness and ability to provide written informed consent
- At least 18 and not more than 75 years of age at study entry
- SARS-CoV-2 infection confirmed by PCR test within 4 days before randomization
- Currently symptomatic (fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia) and at COVID-19 isolation and treatment centre
Who cannot join
- Inability to take orally administered medication or food
- Known hypersensitivity to study medication
- Pregnant or lactating (unless practicing exclusive replacement feeding for the entire study duration)
- Participation in any other interventional trial for COVID-19 (observational study co-enrollment allowed)
- Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 less than 24 hours prior to study drug dosing
- Concurrent use of agents with known or uncertain interaction with study drugs, including ritonavir
Show all 9Show fewer
- Requiring mechanical ventilation at screening
- Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times upper limit of normal (ULN)
- Creatinine clearance below 50 mL/min using the Cockcroft-Gault formula for participants above 18 years of age
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Infectious Disease Hospital, Olodo
Ibadan, Oyo State
Olabisi Onabanjo University Teaching Hospital
Sagamu, Ogun State
About this study
Official title: A Randomized, Open Label Trial to Investigate the Efficacy and Safety of Nitazoxanide Plus Atazanavir/Ritonavir for the Treatment of COVID-19: a Pilot Study
Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans.
In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients in group 2 will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days.
The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.
Read the detailed description
COVID-19 caused by a novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) is an unprecedented global public health challenge which as at July 1, 2020 has spread to over 210 countries with over 10.6 million cases resulting in 514,808 deaths. More than 1500 clinical trials are currently ongoing in an unprecedented global search for potential therapeutics and vaccines. With increasing number of cases reported in low- and middle-income countries and and the possibility of a second wave of infections in countries where the pandemic appears to have slowed, studies to investigate promising therapies are urgently needed, especially those that can significantly reduce time to viral clearance and mortality. Shortening SARS-CoV-2 clearance time will lower treatment cost and reduce the economic impact of the pandemic.
The purpose of this phase 2 trial is to investigate the efficacy and safety of repurposed antiprotozoal and antiretroviral drugs, nitazoxanide and atazanavir/ritonavir, in achievement of SARS-CoV-2 PCR negativity and shorten the time to clinical improvement in patients diagnosed with moderate to severe COVID-19. The selection of candidates for this COVID-19 drug repurposing trial was guided by three pharmacological considerations: (1) demonstration of in-vitro anti-SARS-CoV-2 activity at doses shown or predicted to be tolerated by humans, (2) the feasibility of achieving effective concentration in relevant compartments, and (3) established human safety record.
This is a pilot phase 2, open label randomized controlled trial. A total of 98 patients with confirmed COVID-19 diagnosis (defined as SARS-CoV-2 polymerase chain reaction (PCR) positive nasopharyngeal swab) will be recruited from participating treatment centres. Participants will be randomised to receive either the standard of care (SOC) plus nitazoxanide for 14 days, starting from day 1 or the SOC alone for 14 days.
Participants will be recruited within 2 days of admission into COVID-19 treatment centre. Before enrollment, they will be given adequate information about the trial, opportunity to ask questions, and sufficient time to consider participation. Before any screening procedures, a written consent will be obtained from each eligible subject who agrees to participate in the trial. Participants will then be randomly allocated 1:1 to receive either the SOC alone (control group) or SOC plus study drug (intervention group). Parallel assignment will be used to prevent sample size imbalance between groups and control for important covariates (e.g. age, comorbidities, gender) that may affect trial results. Participants in the intervention group will receive 1000 mg nitazoxanide (two tablets of 500 mg each) with meal two times daily (8 am and 8 pm) and one tablet of 300/100 mg atazanavir/ritonavir with meal once daily (8 pm) in addition SOC. Participants in the control arm will receive the SOC alone. SOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19.
The treatment duration for participants in the intervention group will be 14 days. However, follow up will continue until day 28 after study entry at the end of which all participants will exit the study. Evaluations at follow up visits will include daily symptoms monitoring using inFLUenza Patient-Reported Outcome (FLU-PRO) questionnaire, daily vitals, daily clinical improvement assessment, and swab and/or sputum collection for SARS-CoV-2 on days 2, 4, 6, 7, 14, and 28.
Sample size estimation is based on the assumption that an improvement of at least 60-80% in time to SARS-CoV-2 PCR negativity and symptoms resolution can be achieved in the intervention group compared with the control group. Hence, a total sample size of 89 will provide at least 80% power to show or exclude 60% improvement in time to SARS-CoV-2 PCR negativity. This assumes a two-sided and 5% type 1 error rate. Therefore, providing for a 10% loss to follow up rate, a total of 98 patients will be recruited.
- Conditions
- Covid-19
- Being tested
- Nitazoxanide and atazanavir/ritonavir, Standard of Care
- Keywords
- SARS-CoV infection, COVID-19, coronavirus
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitazoxanide and atazanavir/ritonavirDrug
1000 mg nitazoxanide tablets twice daily and 300/100 mg atazanavir/ritonavir tablets once daily with meal
Standard of CareOther
SOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Participants in this arm will receive SOC alone, which will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19 Receives: Other: Standard of Care |
| SOC plus Intervention | Experimental | Participants in this arm will receive SOC plus study intervention composed of orally administered nitazoxanide and atazanavir/ritonavir tablets Receives: Drug: Nitazoxanide and atazanavir/ritonavir; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
Proportion of patients with clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a 7-point ordinal scale, or both.
Measured: 28 days
Time to SARS-CoV-2 negativity
Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at Days 7, 10, 14 and 28
Measured: 28 days
Difference in SARS-CoV-2 AUC
Temporal patterns of SARS-CoV-2 viral load quantified by RT-PCR from nasal swabs or sputum of patients receiving SOC alone versus SOC plus study drug
Measured: 28 days
Secondary outcomes (6)
Time to symptoms resolution
Time to symptoms resolution as monitored by the Performance of the inFLUenza Patient-Reported Outcome (FLU-PRO) questionnaire with some modifications for COVID-19
Measured: 28 days
Clinical status as assessed with the seven-category ordinal scale on days 7 and 14
Measured: 14 days
Duration of hospitalization in survivors
Measured: 28 days
Day 28 mortality
Measured: 28 days
Time from treatment initiation to death
Measured: 28 days
Proportion with viral RNA detection over time
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 posted7 Jul 2020
- Study start9 Oct 2020
- Primary completion2 May 2021
- Study completion2 May 2021
Why it stopped: IDSMB recommendation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obafemi Awolowo University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liverpool, African Centre of Excellence for Genomics of Infectious Diseases, Infectious Disease Hospital Olodo, Obafemi Awolowo University Teaching Hospital, Osun State Ministry of Health, Olabisi Onabanjo University Teaching Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459286
- Sponsor's protocol ID
- NACOVID
- Acronym
- NACOVID
- Status last verified
- Feb 2022
- First submitted
- 3 Jul 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.
PubMed 27095301Cao J, Forrest JC, Zhang X. A screen of the NIH Clinical Collection small molecule library identifies potential anti-coronavirus drugs. Antiviral Res. 2015 Feb;114:1-10. doi: 10.1016/j.antiviral.2014.11.010. Epub 2014 Nov 28.
PubMed 25451075Haffizulla J, Hartman A, Hoppers M, Resnick H, Samudrala S, Ginocchio C, Bardin M, Rossignol JF; US Nitazoxanide Influenza Clinical Study Group. Effect of nitazoxanide in adults and adolescents with acute uncomplicated influenza: a double-blind, randomised, placebo-controlled, phase 2b/3 trial. Lancet Infect Dis. 2014 Jul;14(7):609-18. doi: 10.1016/S1473-3099(14)70717-0. Epub 2014 May 19.
PubMed 24852376Arshad U, Pertinez H, Box H, Tatham L, Rajoli RKR, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, O'Neill PM, Aljayyoussi G, Pennington SH, Ward SA, Hill A, Back DJ, Khoo SH, Bray PG, Biagini GA, Owen A. Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics. Clin Pharmacol Ther. 2020 Oct;108(4):775-790. doi: 10.1002/cpt.1909. Epub 2020 Jun 14.
PubMed 32438446Rajoli RK, Pertinez H, Arshad U, Box H, Tatham L, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, Aljayyoussi G, Pennington SH, Hill A, Boffito M, Ward SA, Khoo SH, Bray PG, O'Neill PM, Hong WD, Biagini G, Owen A. Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis. medRxiv [Preprint]. 2020 May 6:2020.05.01.20087130. doi: 10.1101/2020.05.01.20087130.
PubMed 32511548Fowotade A, Bamidele F, Egbetola B, Fagbamigbe AF, Adeagbo BA, Adefuye BO, Olagunoye A, Ojo TO, Adebiyi AO, Olagunju OI, Ladipo OT, Akinloye A, Onayade A, Bolaji OO, Rannard S, Happi C, Owen A, Olagunju A. A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19. Front Med (Lausanne). 2022 Sep 8;9:956123. doi: 10.3389/fmed.2022.956123. eCollection 2022.
PubMed 36160134Olagunju A, Fowotade A, Olagunoye A, Ojo TO, Adefuye BO, Fagbamigbe AF, Adebiyi AO, Olagunju OI, Ladipo OT, Akinloye A, Adeagbo BA, Onayade A, Bolaji OO, Happi C, Rannard S, Owen A. Efficacy and safety of nitazoxanide plus atazanavir/ritonavir for the treatment of moderate to severe COVID-19 (NACOVID): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 4;22(1):3. doi: 10.1186/s13063-020-04987-8.
PubMed 33397457
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label Trial to Investigate the Efficacy and Safety of Nitazoxanide Plus Atazanavir/Ritonavir for the Treatment of COVID-19: a Pilot Study
- ClinicalTrials.gov ID
- NCT04459286
- Acronym / sponsor ID
- NACOVID / NACOVID
- Conditions
- Covid-19
- Keywords
- SARS-CoV infection, COVID-19, coronavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IDSMB recommendation
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Obafemi Awolowo UniversityUniversity, hospital or other
- Collaborators
- University of Liverpool, African Centre of Excellence for Genomics of Infectious Diseases, Infectious Disease Hospital Olodo, Obafemi Awolowo University Teaching Hospital, Osun State Ministry of Health, Olabisi Onabanjo University Teaching Hospital
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 2 May 2021 (actual)
- Study completion
- 2 May 2021 (actual)
- First posted
- 7 Jul 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.
Since the outbreak of the novel coronavirus disease in 2019 (COVID-19), an unprecedented global search for potential therapeutics and vaccines is ongoing. In this study, a combination of two drugs that have been shown to be effective against the germ that causes COVID-19 in the laboratory will be tested in patients diagnosed with moderate to severe COVID-19. One of the drugs is called nitazoxanide and the second is atazanavir/ritonavir. Nitazoxanide has been used for the treatment of diarrhea since 2004 while atazanavir/ritonavir was approved for HIV treatment in 2003. They are known to be safe in humans.
In this pilot study, 98 COVID-19 patients will be recruited into two groups. The 49 patients in group 1 will receive the standard of care determined by their primary care providers while the 49 patients in group 2 will receive both the standard of care combined with the two study drugs. Patients in group 2 will receive the study drugs for 14 days and all patients will be monitored for a total of 28 days.
The time it takes for the germ that causes COVID-19 to be completely removed from the body (in nasal secretions) and the time to clinical improvement will be monitored in all patients and compared between the two groups.
Detailed description
COVID-19 caused by a novel severe acute respiratory syndrome coronavirus (SARS-CoV-2) is an unprecedented global public health challenge which as at July 1, 2020 has spread to over 210 countries with over 10.6 million cases resulting in 514,808 deaths. More than 1500 clinical trials are currently ongoing in an unprecedented global search for potential therapeutics and vaccines. With increasing number of cases reported in low- and middle-income countries and and the possibility of a second wave of infections in countries where the pandemic appears to have slowed, studies to investigate promising therapies are urgently needed, especially those that can significantly reduce time to viral clearance and mortality. Shortening SARS-CoV-2 clearance time will lower treatment cost and reduce the economic impact of the pandemic.
The purpose of this phase 2 trial is to investigate the efficacy and safety of repurposed antiprotozoal and antiretroviral drugs, nitazoxanide and atazanavir/ritonavir, in achievement of SARS-CoV-2 PCR negativity and shorten the time to clinical improvement in patients diagnosed with moderate to severe COVID-19. The selection of candidates for this COVID-19 drug repurposing trial was guided by three pharmacological considerations: (1) demonstration of in-vitro anti-SARS-CoV-2 activity at doses shown or predicted to be tolerated by humans, (2) the feasibility of achieving effective concentration in relevant compartments, and (3) established human safety record.
This is a pilot phase 2, open label randomized controlled trial. A total of 98 patients with confirmed COVID-19 diagnosis (defined as SARS-CoV-2 polymerase chain reaction (PCR) positive nasopharyngeal swab) will be recruited from participating treatment centres. Participants will be randomised to receive either the standard of care (SOC) plus nitazoxanide for 14 days, starting from day 1 or the SOC alone for 14 days.
Participants will be recruited within 2 days of admission into COVID-19 treatment centre. Before enrollment, they will be given adequate information about the trial, opportunity to ask questions, and sufficient time to consider participation. Before any screening procedures, a written consent will be obtained from each eligible subject who agrees to participate in the trial. Participants will then be randomly allocated 1:1 to receive either the SOC alone (control group) or SOC plus study drug (intervention group). Parallel assignment will be used to prevent sample size imbalance between groups and control for important covariates (e.g. age, comorbidities, gender) that may affect trial results. Participants in the intervention group will receive 1000 mg nitazoxanide (two tablets of 500 mg each) with meal two times daily (8 am and 8 pm) and one tablet of 300/100 mg atazanavir/ritonavir with meal once daily (8 pm) in addition SOC. Participants in the control arm will receive the SOC alone. SOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19.
The treatment duration for participants in the intervention group will be 14 days. However, follow up will continue until day 28 after study entry at the end of which all participants will exit the study. Evaluations at follow up visits will include daily symptoms monitoring using inFLUenza Patient-Reported Outcome (FLU-PRO) questionnaire, daily vitals, daily clinical improvement assessment, and swab and/or sputum collection for SARS-CoV-2 on days 2, 4, 6, 7, 14, and 28.
Sample size estimation is based on the assumption that an improvement of at least 60-80% in time to SARS-CoV-2 PCR negativity and symptoms resolution can be achieved in the intervention group compared with the control group. Hence, a total sample size of 89 will provide at least 80% power to show or exclude 60% improvement in time to SARS-CoV-2 PCR negativity. This assumes a two-sided and 5% type 1 error rate. Therefore, providing for a 10% loss to follow up rate, a total of 98 patients will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Other: Standard of CareParticipants in this arm will receive SOC alone, which will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19 |
| SOC plus Intervention | Experimental | Drug: Nitazoxanide and atazanavir/ritonavir, Other: Standard of CareParticipants in this arm will receive SOC plus study intervention composed of orally administered nitazoxanide and atazanavir/ritonavir tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willingness and ability to provide written informed consent
- At least 18 and not more than 75 years of age at study entry
- SARS-CoV-2 infection confirmed by PCR test within 4 days before randomization
- Currently symptomatic (fever or chills, cough, myalgia, sore throat, shortness of breath, or new onset of anosmia or ageusia) and at COVID-19 isolation and treatment centre
Key exclusion criteria (9 listed)
- Inability to take orally administered medication or food
- Known hypersensitivity to study medication
- Pregnant or lactating (unless practicing exclusive replacement feeding for the entire study duration)
- Participation in any other interventional trial for COVID-19 (observational study co-enrollment allowed)
- Concurrent treatment with other agents with actual or possible direct-acting antiviral activity against SARS-CoV-2 less than 24 hours prior to study drug dosing
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 |
|---|---|---|
| Nitazoxanide and atazanavir/ritonavir1000 mg nitazoxanide tablets twice daily and 300/100 mg atazanavir/ritonavir tablets once daily with meal | Drug | SOC plus Intervention |
| Standard of CareSOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19 | Other | SOC plus Intervention, Standard of Care (SOC) |
Primary outcome
Time to clinical improvement
Time frame: 28 days
Proportion of patients with clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a 7-point ordinal scale, or both.
Time to SARS-CoV-2 negativity
Time frame: 28 days
Proportion of participants with SARS-CoV-2 polymerase chain reaction (PCR) negative result at Days 7, 10, 14 and 28
Difference in SARS-CoV-2 AUC
Time frame: 28 days
Temporal patterns of SARS-CoV-2 viral load quantified by RT-PCR from nasal swabs or sputum of patients receiving SOC alone versus SOC plus study drug
6 secondary outcomes
Time to symptoms resolution
Time frame: 28 days
Clinical status as assessed with the seven-category ordinal scale on days 7 and 14
Time frame: 14 days
Duration of hospitalization in survivors
Time frame: 28 days
Day 28 mortality
Time frame: 28 days
Time from treatment initiation to death
Time frame: 28 days
Proportion with viral RNA detection over time
Time frame: 28 days
Results and safety
The study was stopped early (reason given: IDSMB recommendation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Background: PubMed 27095301Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.
- Background: PubMed 25451075Cao J, Forrest JC, Zhang X. A screen of the NIH Clinical Collection small molecule library identifies potential anti-coronavirus drugs. Antiviral Res. 2015 Feb;114:1-10. doi: 10.1016/j.antiviral.2014.11.010. Epub 2014 Nov 28.
- Background: PubMed 24852376Haffizulla J, Hartman A, Hoppers M, Resnick H, Samudrala S, Ginocchio C, Bardin M, Rossignol JF; US Nitazoxanide Influenza Clinical Study Group. Effect of nitazoxanide in adults and adolescents with acute uncomplicated influenza: a double-blind, randomised, placebo-controlled, phase 2b/3 trial. Lancet Infect Dis. 2014 Jul;14(7):609-18. doi: 10.1016/S1473-3099(14)70717-0. Epub 2014 May 19.
- Background: PubMed 32438446Arshad U, Pertinez H, Box H, Tatham L, Rajoli RKR, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, O'Neill PM, Aljayyoussi G, Pennington SH, Ward SA, Hill A, Back DJ, Khoo SH, Bray PG, Biagini GA, Owen A. Prioritization of Anti-SARS-Cov-2 Drug Repurposing Opportunities Based on Plasma and Target Site Concentrations Derived from their Established Human Pharmacokinetics. Clin Pharmacol Ther. 2020 Oct;108(4):775-790. doi: 10.1002/cpt.1909. Epub 2020 Jun 14.
- Background: PubMed 32511548Rajoli RK, Pertinez H, Arshad U, Box H, Tatham L, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, Aljayyoussi G, Pennington SH, Hill A, Boffito M, Ward SA, Khoo SH, Bray PG, O'Neill PM, Hong WD, Biagini G, Owen A. Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis. medRxiv [Preprint]. 2020 May 6:2020.05.01.20087130. doi: 10.1101/2020.05.01.20087130.
- Derived from this study: PubMed 36160134Fowotade A, Bamidele F, Egbetola B, Fagbamigbe AF, Adeagbo BA, Adefuye BO, Olagunoye A, Ojo TO, Adebiyi AO, Olagunju OI, Ladipo OT, Akinloye A, Onayade A, Bolaji OO, Rannard S, Happi C, Owen A, Olagunju A. A randomized, open-label trial of combined nitazoxanide and atazanavir/ritonavir for mild to moderate COVID-19. Front Med (Lausanne). 2022 Sep 8;9:956123. doi: 10.3389/fmed.2022.956123. eCollection 2022.
- Derived from this study: PubMed 33397457Olagunju A, Fowotade A, Olagunoye A, Ojo TO, Adefuye BO, Fagbamigbe AF, Adebiyi AO, Olagunju OI, Ladipo OT, Akinloye A, Adeagbo BA, Onayade A, Bolaji OO, Happi C, Rannard S, Owen A. Efficacy and safety of nitazoxanide plus atazanavir/ritonavir for the treatment of moderate to severe COVID-19 (NACOVID): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Jan 4;22(1):3. doi: 10.1186/s13063-020-04987-8.
- Nitaxoxanide Prescribing InformationLink provided by the sponsor.
- Atazanavir inhibits SARS-CoV-2 replication and pro-inflammatory cytokine productionLink provided by the sponsor.
- Atazanavir/ritonavir Prescribing InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide and atazanavir/ritonavir in people with Covid-19, run by Obafemi Awolowo University at 2 sites in Nigeria.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. 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 was stopped early (reason given: IDSMB recommendation). Results are not available in the source record.
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?
Time to clinical improvement (time frame: 28 days). The study lists 3 primary outcomes in all. 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 NCT04459286, which also lists 7 linked publications.
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 Mar 2022.