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)

• ClinicalTrials.gov Identifier: NCT04343248
• Recruitment Status: Active, not recruiting
• First Posted: April 13, 2020
• Last Update Posted: April 1, 2021
• Sponsor: Romark Laboratories L.C.
• Information provided by (Responsible Party): Romark Laboratories L.C.

Tracking Information

• First Submitted Date: April 8, 2020
• First Posted Date: April 13, 2020
• Last Update Posted Date: April 1, 2021
• Actual Study Start Date: May 12, 2020
• Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention

Condition

• COVID-19
• Viral Respiratory Illnesses

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: May 27, 2020): 800
• Original Estimated Enrollment (submitted: April 8, 2020): 300
• Estimated Study Completion Date: June 30, 2021
• Estimated Primary Completion Date: June 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 55 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04343248
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Romark Laboratories L.C.
• Study Sponsor: Romark Laboratories L.C.
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Romark Laboratories L.C.
• Verification Date: March 2021