Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
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| ClinicalTrials.gov Identifier: NCT04359680 |
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Recruitment Status : Unknown
Verified February 2021 by Romark Laboratories L.C..
Recruitment status was: Active, not recruiting
First Posted : April 24, 2020
Last Update Posted : February 8, 2021
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Sponsor:
Romark Laboratories L.C.
Information provided by (Responsible Party):
Romark Laboratories L.C.
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Brief Summary:
Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 Viral Respiratory Illnesses | Drug: Nitazoxanide Drug: Placebo Dietary Supplement: Vitamin Super B-Complex | Phase 3 |
Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1407 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Pre- and Post Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses (VRI) in Healthcare Workers and Others at Increased Risk of SARS-CoV-2 Infection |
| Actual Study Start Date : | May 13, 2020 |
| Estimated Primary Completion Date : | March 29, 2021 |
| Estimated Study Completion Date : | March 29, 2021 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Nitazoxanide
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Nitazoxanide
Two NTZ 300 mg tablets orally twice daily for 6 weeks.
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Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
Other Names:
Dietary Supplement: Vitamin Super B-Complex Vitamin Super B-Complex administered orally twice daily to maintain the blind |
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Placebo Comparator: Placebo
Two placebo tablets orally twice daily for 6 weeks.
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Drug: Placebo
Placebo administered orally twice daily for six weeks Dietary Supplement: Vitamin Super B-Complex Vitamin Super B-Complex administered orally twice daily to maintain the blind |
Primary Outcome Measures :
- 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. [ Time Frame: Up to 6 weeks ]
- 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. [ Time Frame: Up to 6 weeks ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Males and females at least 18 years of age or of legal consenting age based on local requirements.
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Persons at increased risk of contracting COVID-19, including:
- Healthcare workers with known direct occupational exposure to COVID-19 within 7 days prior to enrollment. A qualifying person (i) provides healthcare to patients and/or (ii) typically positions themselves within 6 feet of patients ("close contact") and (iii) is a full- time employee (average of ≥ 24 hours/week) in a high contact area (Emergency Department, Intensive Care Unit, COVID-specific Care Unit, Walk-in Clinic, Paramedic/First Responder).
- Persons participating in social activities without the practice of generally accepted social distancing practices at least three times per week. Qualifying activities include the presence of at least 10 people in close (<6 feet) proximity to each other without masks or other personal protective equipment (e.g., socializing at bars or community/social centers, in-home social gatherings, classes or trainings, etc.). These subjects must have engaged in such activities at least three times in the past 7 days and plan to continue these activities during the study.
- Must have a smartphone, tablet, computer, or other qualifying internet- enabled device and daily internet access.
- Occupational exposure to a person infected with SAR-CoV-2 within 7 days prior to enrollment or social interaction as defined in criterion 2(b).
- Willing and able to provide written informed consent and comply with the requirements of the protocol, including completion of the subject diary.
Exclusion Criteria:
- Subjects not at increased risk of contracting SARS-CoV-2 from occupational or social behaviors.
- Subjects with known severe heart, lung, neurological or other systemic disease that the Investigator believes could preclude safe participation.
- Subjects with a history of COVID-19 or known to have developed anti- SARS-CoV-2 antibodies or received a SARS-CoV-2 vaccine.
- Subjects who experienced a previous episode of acute upper respiratory tract infection, otitis, bronchitis or sinusitis or received antibiotics for these conditions or antiviral therapy for influenza within two weeks prior to and including study day 1.
- Subjects residing in the same household with another family member currently participating in the study.
- Receipt of any dose of NTZ within 7 days prior to screening.
- Treatment with any investigational drug or vaccine therapy within 30 days prior to screening and willing to avoid them during the course of the study.
- Known sensitivity to NTZ or any of the excipients comprising the study medication.
- Subjects unable to swallow oral tablets or capsules.
- Females of childbearing potential who are either pregnant or sexually active without the use of birth control. Female subjects of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue an acceptable method of birth control for the duration of the study and for 1 month post-treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycle prior to study drug administration, an (intrauterine device) IUD, or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral oophorectomy.
- Females who are breastfeeding.
- Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
- Subjects taking medications considered to be major CYP2C8 substrates.
- Subjects who, in the judgment of the Investigator, will be unlikely to comply with the requirements of this protocol including completion of the subject diary.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359680
Locations
Show 26 study locations
Sponsors and Collaborators
Romark Laboratories L.C.
| Responsible Party: | Romark Laboratories L.C. |
| ClinicalTrials.gov Identifier: | NCT04359680 |
| Other Study ID Numbers: |
RM08-3007 |
| First Posted: | April 24, 2020 Key Record Dates |
| Last Update Posted: | February 8, 2021 |
| Last Verified: | February 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Romark Laboratories L.C.:
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COVID-19 Viral Respiratory Illnesses |
Additional relevant MeSH terms:
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COVID-19 Infections Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases Coronavirus Infections Coronaviridae Infections |
Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Nitazoxanide Antiparasitic Agents Anti-Infective Agents |