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Lack of participants willing to enroll
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| Name | Class |
|---|---|
| SynaVir | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Study Drug | Active Comparator | 5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate |
|
| Placebo | Placebo Comparator | 5 day dosing of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitazoxanide | Drug | Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Decline in Viral Load Over the 10 Days After Randomization | qPCR measured via nasal swab | 10 days after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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
Current use of:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey L Carson, MD | Rutgers, The State University of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Study Drug | 5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) |
| FG001 | Placebo | 5 day dosing of placebo Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Study Drug | 5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Decline in Viral Load Over the 10 Days After Randomization | qPCR measured via nasal swab | This trial was terminated due to lack of enrollment. A total of 7 participants were randomized. Study outcome was to be response to antiviral treatment (rate of decline in viral load over the 10 days after randomization) as measured via nasal swab qPCR analysis. Based on the lack of enrollment, the swab analysis was not performed. | Posted | 10 days after randomization |
|
28 Days
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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 | Active Study Drug | 5 day dosing of Nitazoxanide, Ribavirin & Hydroxychloroquine sulfate Nitazoxanide: Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) Ribavirin: Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) Hydroxychloroquine: Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey L Carson, MD | Rutgers, The State University of New Jersey | 732-235-7122 | Jeffrey.Carson@Rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2020 | Apr 5, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2020 | Jul 2, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D045169 | Severe Acute Respiratory Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
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| ID | Term |
|---|---|
| C041747 | nitazoxanide |
| D012254 | Ribavirin |
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D002738 | Chloroquine |
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Study medication will be tablets/capsules containing either active drug or placebo
| Placebo Nitazoxanide | Drug | Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) |
|
| Ribavirin | Drug | Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) |
|
| Placebo Ribavirin | Drug | Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) |
|
| Hydroxychloroquine | Drug | Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) |
|
| Placebo Hydroxychloroquine | Drug | Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) |
|
| BG001 |
| Placebo |
5 day dosing of placebo Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Placebo |
5 day dosing of placebo Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) |
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo | 5 day dosing of placebo Placebo Nitazoxanide: Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days) Placebo Ribavirin: Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days) Placebo Hydroxychloroquine: Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days) | 0 | 5 | 0 | 5 | 0 | 5 |
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| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D000634 |
| Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |