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Trial to Evaluate the Efficacy and Safety of Nitazoxanide (NTZ) for Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04343248
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Brief Summary:
Trial to evaluate the efficacy and safety of NTZ for post-exposure prophylaxis of COVID-19 and other VRIs in elderly LTCF residents.

Condition or disease Intervention/treatment Phase
COVID-19 Viral Respiratory Illnesses Drug: Nitazoxanide Drug: Placebo Dietary Supplement: Vitamin Super B-Complex Phase 3

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 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 Post-Exposure Prophylaxis of COVID-19 and Other Viral Respiratory Illnesses in Elderly Residents of Long-Term Care Facilities (LTCF)
Actual Study Start Date : May 12, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
Drug: Nitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
Other Names:
  • NTZ (nitazoxanide)
  • NT-300

Dietary Supplement: Vitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind

Placebo Comparator: Placebo
Two placebo tablets orally twice daily for 6 weeks
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 :
  1. Symptomatic laboratory-confirmed COVID-19 [ Time Frame: up to 6 weeks ]
    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.

  2. Symptomatic laboratory-confirmed VRI [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 120 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female residents of LTCFs at least 65 years of age.
  • Willing and able to provide written informed consent and comply with the requirements of the protocol.
  • At least one symptomatic laboratory-confirmed COVID-19 illness identified among residents or staff of the LTCF within 10 days prior to randomization.

Exclusion Criteria:

  • Alzheimer's disease, dementia, or other mental incapacity which precludes comprehension of the study requirements or symptom diary.
  • Subjects expected to require hospitalization within the 8-week treatment and follow-up period.
  • Subjects with a history of COVID-19 or known to have developed anti-SARS- CoV-2 antibodies.
  • 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.
  • Receipt of any dose of NTZ within 7 days prior to screening.
  • Treatment with any investigational drug or vaccine within 30 days prior to screening or unwilling 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.
  • 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.

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): NCT04343248


Contacts
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Contact: Matthew Bardin, PharmD, BCPS 813-282-8544 matthew.bardin@romark.com

Locations
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United States, Florida
Clinical Trial Site Recruiting
Kissimmee, Florida, United States, 34744
Contact: Romark    877-925-4642      
United States, Georgia
Clinical Trial Site Recruiting
Acworth, Georgia, United States, 30101
Contact: Romark    877-925-4642      
United States, Louisiana
Clinical Trial Site Recruiting
Lake Charles, Louisiana, United States, 70601
Contact: Romark    877-925-4642      
United States, Texas
Clinical Trial Site Recruiting
Houston, Texas, United States, 77058
Contact: Romark    877-925-4642      
Sponsors and Collaborators
Romark Laboratories L.C.
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Responsible Party: Romark Laboratories L.C.
ClinicalTrials.gov Identifier: NCT04343248    
Other Study ID Numbers: RM08-3006
First Posted: April 13, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020

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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.:
COVID-19
Viral Respiratory Illnesses
Additional relevant MeSH terms:
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Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents