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Study recruitment was halted prematurely as widespread vaccination of the study population made completion infeasible.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitazoxanide | Active Comparator | Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks |
|
| Placebo | Placebo Comparator | Two placebo tablets orally twice daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | Nitazoxanide 600 mg administered orally twice daily for six weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 weeks |
| Mortality Due to COVID-19 or Complications Thereof |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chappel Group Research | Kissimmee | Florida | 34744 | United States | ||
| Clinical Trial Specialists, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitazoxanide | Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks |
| FG001 | Placebo | Two placebo tablets orally twice daily for 6 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 28, 2020 | Jun 6, 2024 |
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| Placebo | Drug | Placebo administered orally twice daily for six weeks |
|
| Vitamin Super B-Complex | Dietary Supplement | Vitamin Super B-Complex administered orally twice daily to maintain the blind |
|
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. |
| 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. | Up to 8 weeks |
| Acworth |
| Georgia |
| 30101 |
| United States |
| Centex Studies, Inc. | Lake Charles | Louisiana | 70601 | United States |
| Centex Studies, Inc. | Houston | Texas | 77058 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population includes all subjects who received at least one dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nitazoxanide | Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks |
| BG001 | Placebo | Two placebo tablets orally twice daily for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Presence of anti-SARS-CoV-2 antibodies | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. Proportions rounded to the nearest hundredth. | Posted | Number | proportion of subjects | up to 6 weeks |
|
|
| |||||||||||||||||||||||||||||
| Primary | 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. | The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. Proportions rounded to the nearest hundredth. | Posted | Number | proportion of subjects | up to 6 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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 | The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. | Posted | Number | proportion of subjects | Up to 6 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. | Posted | Number | proportion of subjects | Up to 6 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. Proportions rounded to the nearest hundredth. | Posted | Number | proportion of subjects | Up to 8 weeks |
|
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nitazoxanide | Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks | 1 | 97 | 10 | 97 | 8 | 97 |
| EG001 | Placebo | Two placebo tablets orally twice daily for 6 weeks | 2 | 93 | 8 | 93 | 9 | 93 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
It was no longer possible to enroll eligible participants in the trial after vaccines were distributed to residents of long-term care facilities. Therefore, enrollment was terminated before the planned enrollment was completed. Study results are summarized descriptively, but no statistical analyses were performed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Research Operations | Romark, L.C. | 8132828544 | jessica.fulgencio@romark.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2024 | Jun 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Anti-SARS-CoV-2 antibodies absent |
|
| Unknown |
|
|
|
|
|