Trial Outcomes & Findings for Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection (NCT NCT04489381)

Last Updated: 2024-10-17

Results Overview

Time to Sustained Response is the time in days from the first dose of study medication to the first time at which the subject reports a decrease in total FLU-PRO score from the previous diary with assessment that symptoms are at least "somewhat better than yesterday", no oral temperature ≥100.4 F in the prior 24 hours, and no future increase in any of the FLU-PRO domains except within validated background levels. NOTE: Data collection ended at study day 21 and \>25% of subjects in each treatment group had not yet achieved Sustained Response (32% in the Nitazoxanide group and 35% in the Placebo group). Therefore, it was impossible to calculate a third quartile for either group. Data presented here imputes "21" as the third quartile. No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

214 participants

Primary outcome timeframe

21 days

Results posted on

2024-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Nitazoxanide Two nitazoxanide 300 mg tablets orally twice daily for 5 days Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind	Placebo Two placebo tablets orally twice daily for 5 days Placebo: Two placebo tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
Overall Study STARTED	104	110
Overall Study COMPLETED	101	107
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Nitazoxanide Two nitazoxanide 300 mg tablets orally twice daily for 5 days Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind	Placebo Two placebo tablets orally twice daily for 5 days Placebo: Two placebo tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
Overall Study Lost to Follow-up	2	3
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Trial to Evaluate Efficacy and Safety of Nitazoxanide in the Treatment of Colds Due to Enterovirus/Rhinovirus Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nitazoxanide n=104 Participants Two nitazoxanide 300 mg tablets orally twice daily for 5 days Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind	Placebo n=110 Participants Two placebo tablets orally twice daily for 5 days Placebo: Two placebo tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind	Total n=214 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 14.7 • n=5 Participants	35 years STANDARD_DEVIATION 13.9 • n=7 Participants	36 years STANDARD_DEVIATION 14.4 • n=5 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	74 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	36 Participants n=7 Participants	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	19 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	90 Participants n=5 Participants	90 Participants n=7 Participants	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	97 Participants n=5 Participants	92 Participants n=7 Participants	189 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Baseline Illness Severity Mild Illness	73 Participants n=5 Participants	68 Participants n=7 Participants	141 Participants n=5 Participants
Baseline Illness Severity Moderate Illness	31 Participants n=5 Participants	42 Participants n=7 Participants	73 Participants n=5 Participants
Subject Risk Status At Increased Risk of Complications	62 Participants n=5 Participants	67 Participants n=7 Participants	129 Participants n=5 Participants
Subject Risk Status Not At Increased Risk of Complications	42 Participants n=5 Participants	43 Participants n=7 Participants	85 Participants n=5 Participants
Time from Symptom Onset to Randomization	39 hours STANDARD_DEVIATION 15.0 • n=5 Participants	40 hours STANDARD_DEVIATION 15.6 • n=7 Participants	39 hours STANDARD_DEVIATION 15.3 • n=5 Participants

PRIMARY outcome

Timeframe: 21 days

Population: All randomized subjects who received at least one dose of study medication and were positive at Baseline for enterovirus/rhinovirus (EV/RV) infection.

Outcome measures

Outcome measures
Measure	Nitazoxanide n=79 Participants Two nitazoxanide 300 mg tablets orally twice daily for 5 days Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind	Placebo n=92 Participants Two placebo tablets orally twice daily for 5 days Placebo: Two placebo tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
Time From First Dose to Sustained Response	13.5 days Interval 6.22 to 21.0	16.3 days Interval 7.32 to 21.0

SECONDARY outcome

Timeframe: 21 days

Population: All randomized subjects who received at least one dose of study medication and were positive at Baseline for enterovirus/rhinovirus (EV/RV) infection. Proportions rounded to the nearest hundredth.

Proportion of subjects requiring systemic antibiotics for an infection secondary to Enterovirus/Rhinovirus. NOTE: No statistical analyses were performed as enrollment was terminated early. See caveats and limitations.

Outcome measures

Outcome measures
Measure	Nitazoxanide n=79 Participants Two nitazoxanide 300 mg tablets orally twice daily for 5 days Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind	Placebo n=92 Participants Two placebo tablets orally twice daily for 5 days Placebo: Two placebo tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
Proportion of Subjects Requiring Systemic Antibiotics	0.03 proportion of participants	0.07 proportion of participants

Adverse Events

Nitazoxanide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nitazoxanide n=104 participants at risk Two nitazoxanide 300 mg tablets orally twice daily for 5 days Nitazoxanide: Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind	Placebo n=110 participants at risk Two placebo tablets orally twice daily for 5 days Placebo: Two placebo tablets administered orally twice daily with food for 5 days Vitamin Super B-Complex: Vitamin Super B-Complex administered orally twice daily to maintain the blind
Gastrointestinal disorders Diarrhoea	2.9% 3/104 • Number of events 3 • 28 days	2.7% 3/110 • Number of events 3 • 28 days
Infections and infestations Bronchitis	0.00% 0/104 • 28 days	2.7% 3/110 • Number of events 3 • 28 days

Additional Information

Jessica Fulgencio

Romark, L.C.

Phone: 8132828544

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place