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)

Purpose

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

Conditions

  • COVID-19
  • Viral Respiratory Illnesses

Eligibility

Eligible Ages
Between 55 Years and 120 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

More Details

NCT ID
NCT04343248
Status
Terminated
Sponsor
Romark Laboratories L.C.

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.