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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)

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ClinicalTrials.gov Identifier: NCT04343248
Recruitment Status : Recruiting
First Posted : April 13, 2020
Last Update Posted : September 18, 2020
Sponsor:
Information provided by (Responsible Party):
Romark Laboratories L.C.

Tracking Information
First Submitted Date  ICMJE April 8, 2020
First Posted Date  ICMJE April 13, 2020
Last Update Posted Date September 18, 2020
Actual Study Start Date  ICMJE May 12, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • COVID-19
  • Viral Respiratory Illnesses
Intervention  ICMJE
  • Drug: Nitazoxanide
    Nitazoxanide 600 mg administered orally twice daily for six weeks
    Other Names:
    • NTZ (nitazoxanide)
    • NT-300
  • 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
Study Arms  ICMJE
  • Active Comparator: Nitazoxanide
    Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
    Interventions:
    • Drug: Nitazoxanide
    • Dietary Supplement: Vitamin Super B-Complex
  • Placebo Comparator: Placebo
    Two placebo tablets orally twice daily for 6 weeks
    Interventions:
    • Drug: Placebo
    • Dietary Supplement: Vitamin Super B-Complex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2020)
800
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2020)
300
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and female residents of LTCFs at least 55 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthew Bardin, PharmD, BCPS 813-282-8544 matthew.bardin@romark.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04343248
Other Study ID Numbers  ICMJE RM08-3006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Romark Laboratories L.C.
Study Sponsor  ICMJE Romark Laboratories L.C.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Romark Laboratories L.C.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP