SARS-CoV InfectionPhase 2TriACTNCT04605588
A Triple Combination Antiviral Coronavirus Therapy (TriACT) for COVID-19
A Phase 2 study testing Nitazoxanide, Ribavirin and Hydroxychloroquine in people with SARS-CoV Infection and Covid19, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
New outpatient treatments for COVID-19 are urgently needed. There is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- SARS-CoV Infection, Covid19
- What is being tested?
- Nitazoxanide, Ribavirin and Hydroxychloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2020to 4 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented SARS-CoV-2 infection by qPCR assay performed within the past 7 days
Who cannot join
- COVID-19 symptoms requiring hospitalization
- PO2 < 92%
- Short of breath at time of enrollment
- Retinal eye disease
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- Known chronic kidney disease, stage - 5 or receiving dialysis
Show all 29Show fewer
- Current use of:
- Class 3 AAD (amiodarone, dronaderone, dofetilide, sotalol)
- Class 1A AAD (procainamide, quinidine, disopyramide)
- Flecainide
- SSRI: citalopram (Celexa), Escitalopram (Lexapro)
- chlorpromazine
- Cilostazol (Pletal)
- Donepezil (Aricept)
- Droperidol
- Fluoconazole
- Methadone
- Ondansetron (Zofran)
- Thioridazine
- Macrolides (clarithromycin, erythromycin)
- Fluroquinolones (ciprofloxacin, levofloxacin, moxifloxacin)
- Tamoxifen
- Pregnancy or women who are breast feeding
- Inability to tolerate oral medications
- Allergy or prior adverse reaction to either hydroxychloroquine sulfate, ribavirin, or nitazoxanide
- Allergy to adhesives
- QTc interval > 450 mSEC for men and women
- History of Torsade de Pointes VT or prior cardiac arrest or congenital long QT interval
- Non-English-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
About this study
Official title: A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo
New outpatient treatments for COVID-19 are urgently needed. There is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. The purpose of this trial is to evaluate the efficacy of Nitazoxanide (NTZ), Ribavirin (RBV) and Hydroxychloroquine (HCQ) versus placebo in participants with proven SARS-CoV-2 infection
The study will enroll 70 participants within the 7 days after having been diagnosed with coronavirus infection. The purpose is to determine if those randomized to 5-day dosing with the three medication combination have decreased viral load and severity of illness in the 10 days following treatment as compared to those taking placebo. Participants will be actively followed for 28 days.
Read the detailed description
Participants will be randomized into one of two treatment plans
- Triple combination:
- Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
- Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
- Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
- No active Medication:
- Placebo administered according to the above schedule
Viral load (qPCR via nasal swab) will be assessed at baseline (day 0) as well as at days 3, 6, and 10 to monitor response to antiviral treatment. Immune status will be determined by antibody testing of blood collected at baseline and day 28. Symptom questionnaires will be completed daily for 10 days and day 28.
- Conditions
- SARS-CoV Infection, Covid19
- Being tested
- Nitazoxanide, Placebo Nitazoxanide, Ribavirin, Placebo Ribavirin, Hydroxychloroquine
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Placebo NitazoxanideDrug
Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
RibavirinDrug
Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Placebo RibavirinDrug
Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
Placebo HydroxychloroquineDrug
Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
| Study group | Role | What they receive |
|---|---|---|
| Active Study Drug | Active comparator | 5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate Receives: Drug: Nitazoxanide; Drug: Ribavirin; Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | 5 day dosing of placebo Receives: Drug: Placebo Nitazoxanide; Drug: Placebo Ribavirin; Drug: Placebo Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Decline in Viral Load Over the 10 Days After Randomization
qPCR measured via nasal swab
Measured: 10 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start2 Dec 2020
- Primary completion17 Jan 2021
- Study completion4 Feb 2021
Why it stopped: Lack of participants willing to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SARS-CoV InfectionStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- SynaVir
- Responsible party
- Principal investigator, Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
- Investigators
- Jeffrey L Carson, MD, Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605588
- Sponsor's protocol ID
- Pro2020001862
- Acronym
- TriACT
- Status last verified
- May 2022
- First submitted
- 26 Oct 2020
- Last updated
- 5 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple Combination Antiviral Coronavirus Therapy (TriACT) RCT Comparing Nitazoxanide, Ribavirin and Hydroxychloroquine vs. Placebo
- ClinicalTrials.gov ID
- NCT04605588
- Acronym / sponsor ID
- TriACT / Pro2020001862
- Conditions
- SARS-CoV Infection, Covid19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of participants willing to enroll
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- SynaVir
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 17 Jan 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 28 Oct 2020 (actual)
- Results
- Posted 5 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
New outpatient treatments for COVID-19 are urgently needed. There is some evidence that a combination of three medications currently used to treat other viral infections could be effective in fighting this new virus. The purpose of this trial is to evaluate the efficacy of Nitazoxanide (NTZ), Ribavirin (RBV) and Hydroxychloroquine (HCQ) versus placebo in participants with proven SARS-CoV-2 infection
The study will enroll 70 participants within the 7 days after having been diagnosed with coronavirus infection. The purpose is to determine if those randomized to 5-day dosing with the three medication combination have decreased viral load and severity of illness in the 10 days following treatment as compared to those taking placebo. Participants will be actively followed for 28 days.
Detailed description
Participants will be randomized into one of two treatment plans
- Triple combination:
- Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
- Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
- Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
- No active Medication:
- Placebo administered according to the above schedule
Viral load (qPCR via nasal swab) will be assessed at baseline (day 0) as well as at days 3, 6, and 10 to monitor response to antiviral treatment. Immune status will be determined by antibody testing of blood collected at baseline and day 28. Symptom questionnaires will be completed daily for 10 days and day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Study Drug | Active comparator | Drug: Nitazoxanide, Drug: Ribavirin, Drug: Hydroxychloroquine5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate |
| Placebo | Placebo comparator | Drug: Placebo Nitazoxanide, Drug: Placebo Ribavirin, Drug: Placebo Hydroxychloroquine5 day dosing of placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Documented SARS-CoV-2 infection by qPCR assay performed within the past 7 days
Key exclusion criteria (29 listed)
- COVID-19 symptoms requiring hospitalization
- PO2 < 92%
- Short of breath at time of enrollment
- Retinal eye disease
- Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
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 |
|---|---|---|
| NitazoxanideNitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) | Drug | Active Study Drug |
| Placebo NitazoxanidePlacebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) | Drug | Placebo |
| RibavirinRibavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) | Drug | Active Study Drug |
| Placebo RibavirinPlacebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) | Drug | Placebo |
| HydroxychloroquineHydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) | Drug | Active Study Drug |
| Placebo HydroxychloroquinePlacebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) | Drug | Placebo |
Primary outcome
Rate of Decline in Viral Load Over the 10 Days After Randomization
Time frame: 10 days after randomization
qPCR measured via nasal swab
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey L Carson, MD principal investigator
Rutgers, The State University of New Jersey
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 Nitazoxanide, Ribavirin and Hydroxychloroquine in people with SARS-CoV Infection and Covid19, run by Rutgers, The State University of New Jersey at 1 site in United States.
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 1 inclusion and 29 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 5 May 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 United States. 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 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?
Yes. Results are posted in the registry (first posted 5 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Decline in Viral Load Over the 10 Days After Randomization (time frame: 10 days after randomization). 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 5 May 2022.