A Phase 3 interventional study of Nitazoxanide and Placebo in COVID-19 and Viral Respiratory Illnesses, sponsored by Romark Laboratories L.C.. Terminated at 4 sites in United States. Open to participants aged 55 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Romark Laboratories L.C. · Phase 3, Interventional, and Prevention
Among 24 studies testing nitazoxanide in COVID-19 — 2 open to participants now, 2 under way, none of them phase 3. nitazoxanide · COVID-19.
Among the 24 studies testing nitazoxanide in COVID-19, this one is the 12th largest by enrollment, is one of 18 that started in 2020, is one of 6 in phase 3, and was the 2nd registered.
7,992 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →2 of the 24 studies testing nitazoxanide in COVID-19 are open now, in 7 countries. Recruiting first, the newest first:
University of Oxford · Sites in Brazil, Laos, Nepal and 2 more countries
Ages 18–60
University of Liverpool · Sites in South Africa, United Kingdom
Ages 18+
By country, each count listing its studies:
nitazoxanide: first FDA approval 2002 (ALINIA). What it is approved for, and how studies give it, is on its page →
Of the 356 COVID-19 studies recruiting now, 206 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 135 take healthy volunteers.
This study: 55 Years to 120 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
24 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 16 · Phase 3 12 · Phase 4 1
First in 2020; this study’s year is marked. 18 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 190 is above the median of 102 across 4,365 interventional studies indexed under COVID-19.
Median enrollment 163 across the 24 interventional studies. Of the 12 that completed or were terminated, 5 (42%) have results posted.
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11 of 24 have an industry lead sponsor. The 10 most frequent:
Romark Laboratories L.C. is the lead sponsor of 29 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.
Romark Laboratories L.C. has 5 studies filed under COVID-19 — fewer than ten, so there is no comparison to draw.
2 of the studies testing nitazoxanide in COVID-19 that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05041907University of OxfordFinding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) | 2027-01 |
| NCT04746183University of LiverpoolAGILE (Early Phase Platform Trial for COVID-19) | 2027-03-31 |
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Among the 24 studies testing nitazoxanide in COVID-19, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.
Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
Drug: Nitazoxanide · Dietary Supplement: Vitamin Super B-Complex
Two placebo tablets orally twice daily for 6 weeks
Drug: Placebo · Dietary Supplement: Vitamin Super B-Complex
Nitazoxanide 600 mg administered orally twice daily for six weeks
Also known as: NTZ (nitazoxanide), NT-300
Placebo administered orally twice daily for six weeks
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Symptomatic Laboratory-confirmed COVID-19
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: up to 6 weeks
Symptomatic Laboratory-confirmed VRI
The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: up to 6 weeks
Hospitalization Due to COVID-19 or Complications Thereof
Proportion of subjects hospitalized due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations
Time frame: Up to 6 weeks
Mortality Due to COVID-19 or Complications Thereof
Proportion of subjects experiencing mortality due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: Up to 6 weeks
Presence of Anti-SARS-CoV-2 at Weeks 6 or 8
Proportion of subjects with anti-SARS-CoV-2 antibodies at Week 6 or 8 visits. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: Up to 8 weeks
| Milestone | Nitazoxanide | Placebo |
|---|---|---|
| Started | 97 | 93 |
| Completed | 81 | 78 |
| Not completed | 16 | 15 |
| Withdrew: Withdrawal by subject | 5 | 6 |
| Withdrew: Death | 1 | 2 |
| Withdrew: Lost to follow-up | 9 | 6 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Adverse event | 1 | 0 |
The proportion of subjects with symptomatic laboratory-confirmed COVID-19 identified after start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
| proportion of subjects | Nitazoxanide | Placebo |
|---|---|---|
| Symptomatic Laboratory-confirmed COVID-19 | 0.01 | 0.00 |
The proportion of subjects with symptomatic laboratory-confirmed VRI identified after the start of treatment and before the end of the 6-week treatment period. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
| proportion of subjects | Nitazoxanide | Placebo |
|---|---|---|
| Symptomatic Laboratory-confirmed VRI | 0.01 | 0.00 |
Proportion of subjects hospitalized due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations
| proportion of subjects | Nitazoxanide | Placebo |
|---|---|---|
| Hospitalization Due to COVID-19 or Complications Thereof | 0.00 | 0.00 |
Proportion of subjects experiencing mortality due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
| proportion of subjects | Nitazoxanide | Placebo |
|---|---|---|
| Mortality Due to COVID-19 or Complications Thereof | 0.00 | 0.00 |
Proportion of subjects with anti-SARS-CoV-2 antibodies at Week 6 or 8 visits. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
| proportion of subjects | Nitazoxanide | Placebo |
|---|---|---|
| Presence of Anti-SARS-CoV-2 at Weeks 6 or 8 | 0.21 | 0.27 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nitazoxanide | 1/97 (1%) | 10/97 (10.3%) | 8/97 (8.2%) |
| Placebo | 2/93 (2.2%) | 8/93 (8.6%) | 9/93 (9.7%) |
| Event | Nitazoxanide | Placebo |
|---|---|---|
| Cardiac arrestCardiac disorders | 0/97 | 1/93 |
| Cardiovascular disorderCardiac disorders | 0/97 | 1/93 |
| DiarrhoeaGastrointestinal disorders | 0/97 | 1/93 |
| Urinary tract infectionInfections and infestations | 1/97 | 1/93 |
| Musculoskeletal chest painMusculoskeletal and connective tissue disorders | 0/97 | 1/93 |
| Cerebrovascular accidentNervous system disorders | 0/97 | 1/93 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/97 | 1/93 |
| Peripheral ischaemiaVascular disorders | 0/97 | 1/93 |
| Cardiac failure acuteCardiac disorders | 1/97 | 0/93 |
| Cardiac failure congestiveCardiac disorders | 1/97 | 0/93 |
| Event | Nitazoxanide | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 4/97 | 5/93 |
| Urinary tract infectionInfections and infestations | 4/97 | 5/93 |
The safety population includes all subjects who received at least one dose of study medication.
| Age, Continuous(years) | Nitazoxanide | Placebo | Total |
|---|---|---|---|
| Mean | 75 ± 9.1 | 73 ± 10.0 | 74 ± 9.6 |
| Sex: Female, Male(Participants) | Nitazoxanide | Placebo | Total |
|---|---|---|---|
| Female | 39 | 36 | 75 |
| Male | 58 | 57 | 115 |
| Ethnicity (NIH/OMB)(Participants) | Nitazoxanide | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 6 | 15 |
| Not Hispanic or Latino | 87 | 86 | 173 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Nitazoxanide | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 2 | 3 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 19 | 17 | 36 |
| White | 76 | 73 | 149 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Presence of anti-SARS-CoV-2 antibodies(Participants) | Nitazoxanide | Placebo | Total |
|---|---|---|---|
| Anti-SARS-CoV-2 antibodies present | 14 | 20 | 34 |
| Anti-SARS-CoV-2 antibodies absent | 78 | 65 | 143 |
| Unknown | 5 | 8 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2020 to primary completion in Feb 2021, 8 months.
Results were first posted in Jul 2024, 3 years 5 months after primary completion. A results delay was requested in Jun 2022.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nitazoxanide