A Phase 2 interventional study of Nitazoxanide and Placebo Nitazoxanide in SARS-CoV Infection and Covid19, sponsored by Rutgers, The State University of New Jersey. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Rutgers, The State University of New Jersey · Phase 2, Interventional, and Treatment
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.
Participants will be randomized into one of two treatment plans
Triple combination:
No active Medication:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 7 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Rutgers, The State University of New Jersey is the lead sponsor of 496 studies on the registry; 130 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 30 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Current use of:
5 day dosing of Nitazoxanide, Ribavirin \& Hydroxychloroquine sulfate
Drug: Nitazoxanide · Drug: Ribavirin · Drug: Hydroxychloroquine
5 day dosing of placebo
Drug: Placebo Nitazoxanide · Drug: Placebo Ribavirin · Drug: Placebo Hydroxychloroquine
Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
Placebo 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)
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 Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
Rate of Decline in Viral Load Over the 10 Days After Randomization
qPCR measured via nasal swab
Time frame: 10 days after randomization
| Milestone | Active Study Drug | Placebo |
|---|---|---|
| Started | 2 | 5 |
| Completed | 1 | 5 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
qPCR measured via nasal swab
No measurements were reported for this outcome.
Collected over 28 Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Study Drug | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Placebo | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Age, Continuous(years) | Active Study Drug | Placebo | Total |
|---|---|---|---|
| Mean | 38 ± 2.8 | 44 ± 15.0 | 42 ± 12.6 |
| Sex: Female, Male(Participants) | Active Study Drug | Placebo | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 0 | 2 | 2 |
| Race (NIH/OMB)(Participants) | Active Study Drug | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 4 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Rutgers, The State University of New Jersey