Trial Outcomes & Findings for 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) (NCT NCT04343248)
NCT ID: NCT04343248
Last Updated: 2024-07-08
Results Overview
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.
TERMINATED
PHASE3
190 participants
up to 6 weeks
2024-07-08
Participant Flow
Participant milestones
| Measure |
Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
93
|
|
Overall Study
COMPLETED
|
81
|
78
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
Reasons for withdrawal
| Measure |
Nitazoxanide
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
9
|
6
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Nitazoxanide
n=97 Participants
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
n=93 Participants
Two placebo tablets orally twice daily for 6 weeks
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75 years
STANDARD_DEVIATION 9.1 • n=93 Participants
|
73 years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
74 years
STANDARD_DEVIATION 9.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
115 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
87 Participants
n=93 Participants
|
86 Participants
n=4 Participants
|
173 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
149 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Presence of anti-SARS-CoV-2 antibodies
Anti-SARS-CoV-2 antibodies present
|
14 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Presence of anti-SARS-CoV-2 antibodies
Anti-SARS-CoV-2 antibodies absent
|
78 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
143 Participants
n=27 Participants
|
|
Presence of anti-SARS-CoV-2 antibodies
Unknown
|
5 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: up to 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Nitazoxanide
n=85 Participants
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
n=81 Participants
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Symptomatic Laboratory-confirmed COVID-19
|
0.01 proportion of subjects
|
0.00 proportion of subjects
|
PRIMARY outcome
Timeframe: up to 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Nitazoxanide
n=85 Participants
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
n=81 Participants
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Symptomatic Laboratory-confirmed VRI
|
0.01 proportion of subjects
|
0.00 proportion of subjects
|
SECONDARY outcome
Timeframe: Up to 6 weeksPopulation: 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.
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
Outcome measures
| Measure |
Nitazoxanide
n=85 Participants
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
n=81 Participants
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Hospitalization Due to COVID-19 or Complications Thereof
|
0.00 proportion of subjects
|
0.00 proportion of subjects
|
SECONDARY outcome
Timeframe: Up to 6 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Nitazoxanide
n=85 Participants
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
n=81 Participants
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Mortality Due to COVID-19 or Complications Thereof
|
0.00 proportion of subjects
|
0.00 proportion of subjects
|
SECONDARY outcome
Timeframe: Up to 8 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Nitazoxanide
n=85 Participants
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
n=81 Participants
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Presence of Anti-SARS-CoV-2 at Weeks 6 or 8
|
0.21 proportion of subjects
|
0.27 proportion of subjects
|
Adverse Events
Nitazoxanide
Placebo
Serious adverse events
| Measure |
Nitazoxanide
n=97 participants at risk
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
n=93 participants at risk
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/97 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Cardiac disorders
Cardiac failure acute
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/97 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/97 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Infections and infestations
Pneumonia
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/97 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/97 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Syncope
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
1/97 • Number of events 1 • 8 weeks
|
0.00%
0/93 • 8 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/97 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/97 • 8 weeks
|
1.1%
1/93 • Number of events 1 • 8 weeks
|
Other adverse events
| Measure |
Nitazoxanide
n=97 participants at risk
Two Nitazoxanide 300 mg tablets orally twice daily for 6 weeks
|
Placebo
n=93 participants at risk
Two placebo tablets orally twice daily for 6 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.1%
4/97 • Number of events 4 • 8 weeks
|
5.4%
5/93 • Number of events 7 • 8 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.1%
4/97 • Number of events 4 • 8 weeks
|
5.4%
5/93 • Number of events 6 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place