COVID-19, Viral Respiratory Illnesses
Conditions
Keywords
COVID-19, Viral Respiratory Illnesses
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.
Interventions
DRUGNitazoxanide
Nitazoxanide 600 mg administered orally twice daily for six weeks
DRUGPlacebo
Placebo administered orally twice daily for six weeks
DIETARY_SUPPLEMENTVitamin Super B-Complex
Vitamin Super B-Complex administered orally twice daily to maintain the blind
Sponsors
Romark Laboratories L.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 120 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic Laboratory-confirmed COVID-19 | 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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations. |
| Symptomatic Laboratory-confirmed VRI | 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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization Due to COVID-19 or Complications Thereof | Up to 6 weeks | Proportion of subjects hospitalized due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations |
| Mortality Due to COVID-19 or Complications Thereof | Up to 6 weeks | Proportion of subjects experiencing mortality due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations. |
| Presence of Anti-SARS-CoV-2 at Weeks 6 or 8 | Up to 8 weeks | Proportion of subjects with anti-SARS-CoV-2 antibodies at Week 6 or 8 visits. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nitazoxanide Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks | 97 |
| Placebo Two placebo tablets orally twice daily for 6 weeks | 93 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 1 | 2 |
| Overall Study | Lost to Follow-up | 9 | 6 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 6 |
Baseline characteristics
| Characteristic | Nitazoxanide | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 75 years STANDARD_DEVIATION 9.1 | 73 years STANDARD_DEVIATION 10 | 74 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 6 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 87 Participants | 86 Participants | 173 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Presence of anti-SARS-CoV-2 antibodies Anti-SARS-CoV-2 antibodies absent | 78 Participants | 65 Participants | 143 Participants |
| Presence of anti-SARS-CoV-2 antibodies Anti-SARS-CoV-2 antibodies present | 14 Participants | 20 Participants | 34 Participants |
| Presence of anti-SARS-CoV-2 antibodies Unknown | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 17 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 76 Participants | 73 Participants | 149 Participants |
| Sex: Female, Male Female | 39 Participants | 36 Participants | 75 Participants |
| Sex: Female, Male Male | 58 Participants | 57 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 97 | 2 / 93 |
| other Total, other adverse events | 8 / 97 | 9 / 93 |
| serious Total, serious adverse events | 10 / 97 | 8 / 93 |
Outcome results
Primary
Symptomatic Laboratory-confirmed COVID-19
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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: up to 6 weeks
Population: The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. Proportions rounded to the nearest hundredth.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nitazoxanide | Symptomatic Laboratory-confirmed COVID-19 | 0.01 proportion of subjects |
| Placebo | Symptomatic Laboratory-confirmed COVID-19 | 0.00 proportion of subjects |
Primary
Symptomatic Laboratory-confirmed VRI
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. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: up to 6 weeks
Population: The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. Proportions rounded to the nearest hundredth.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nitazoxanide | Symptomatic Laboratory-confirmed VRI | 0.01 proportion of subjects |
| Placebo | Symptomatic Laboratory-confirmed VRI | 0.00 proportion of subjects |
Secondary
Hospitalization Due to COVID-19 or Complications Thereof
Proportion of subjects hospitalized due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations
Time frame: Up to 6 weeks
Population: The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nitazoxanide | Hospitalization Due to COVID-19 or Complications Thereof | 0.00 proportion of subjects |
| Placebo | Hospitalization Due to COVID-19 or Complications Thereof | 0.00 proportion of subjects |
Secondary
Mortality Due to COVID-19 or Complications Thereof
Proportion of subjects experiencing mortality due to COVID-19 or complications thereof. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: Up to 6 weeks
Population: The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nitazoxanide | Mortality Due to COVID-19 or Complications Thereof | 0.00 proportion of subjects |
| Placebo | Mortality Due to COVID-19 or Complications Thereof | 0.00 proportion of subjects |
Secondary
Presence of Anti-SARS-CoV-2 at Weeks 6 or 8
Proportion of subjects with anti-SARS-CoV-2 antibodies at Week 6 or 8 visits. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.
Time frame: Up to 8 weeks
Population: The primary efficacy population consists of all subjects who received at least one dose of study medication and were negative for all respiratory viruses at Baseline. Proportions rounded to the nearest hundredth.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nitazoxanide | Presence of Anti-SARS-CoV-2 at Weeks 6 or 8 | 0.21 proportion of subjects |
| Placebo | Presence of Anti-SARS-CoV-2 at Weeks 6 or 8 | 0.27 proportion of subjects |