Trial Outcomes & Findings for Niclosamide for Mild to Moderate COVID-19 (NCT NCT04399356)
NCT ID: NCT04399356
Last Updated: 2022-04-12
Results Overview
Respiratory viral clearance is defined as the first day a participant's oropharyngeal (oral) sample result is negative, provided that none of the subsequent oral sample results are positive. We will calculate the time to clearance since Day 1.
COMPLETED
PHASE2
73 participants
Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.
2022-04-12
Participant Flow
Enrollment was among individuals reporting at Tufts Medical Center and Wellforce Network in Massachusetts for outpatient COVID-19 testing. The trial opened to accrual on October 1, 2020; the last participant enrolled on April 20, 2021.
Of 139 participants were assessed for eligibility, 73 met inclusion criteria and were randomized to treatment (66 participants were excluded: 23 did not meet inclusion criteria, 42 declined participation, 1 co-habited with a previously enrolled participant).
Participant milestones
| Measure |
Niclosamide- Experimental Group
Participants received Niclosamide 2 grams by mouth daily for 7 days.
|
Control Group
Participants received placebo using the same dosing schedule as Experimental Group
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
|
Overall Study
COMPLETED
|
33
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Niclosamide- Experimental Group
Participants received Niclosamide 2 grams by mouth daily for 7 days.
|
Control Group
Participants received placebo using the same dosing schedule as Experimental Group
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Discontinued Niclosamide/ Placebo
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Niclosamide for Mild to Moderate COVID-19
Baseline characteristics by cohort
| Measure |
Niclosamide
n=33 Participants
Participants in the treatment arm will receive Niclosamide 2 grams orally on day 1 and daily for 6 more days (total 7 days of treatment)
Niclosamide: Participants in the treatment arm will receive Niclosamide 2 grams orally once daily for 7 days in addition to current standard of care treatment. Oropharyngeal swab samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14. Fecal samples will be collected for viral shedding as measured by PCR on days 3, 7, 10, 14, 21. A baseline fecal and oropharyngeal sample will be obtained on Day 1 prior to starting dosing of Niclosamide/ placebo.
Telehealth monitoring: In addition to Niclosamide or placebo treatments, all enrolled patients will be provided a home thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. The collection of oropharyngeal samples will be directly observed by a Study Team member via the telehealth platform.
|
Control
n=34 Participants
Participants in the control group will receive identical-appearing placebo by mouth in the same numbers of pills on day 1 and daily for 6 more days (total 7 days of treatment)
Placebo: The collection of oropharyngeal samples will be observed by a Study Team member via the telehealth platform.
Telehealth monitoring: In addition to Niclosamide or placebo treatments, all enrolled patients will be provided a home thermometer as well as a fingertip probe pulse oximeter, with the specific instructions to monitor both temperature at oxygen saturation at the time of daily oral administration of drug. The collection of oropharyngeal samples will be directly observed by a Study Team member via the telehealth platform.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.82 years
STANDARD_DEVIATION 12.92 • n=5 Participants
|
35.97 years
STANDARD_DEVIATION 13.27 • n=7 Participants
|
36.39 years
STANDARD_DEVIATION 13.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 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
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Reduction in viral shedding as measured by oropharyngeal swab on days, 3, 7, 10, 14.Population: We evaluated efficacy of niclosamide in shortening contagious period as determined by time to oropharyngeal viral clearance. Primary analysis was based on ITT population (all randomized participants). The cumulative probability of being in clearance in each randomization group was calculated using the Kaplan-Meier estimator. The cumulative probability of clearance at day 3 between the groups was calculated using a chi-square test based on a log(- log(·)) transformation for the survival function.
Respiratory viral clearance is defined as the first day a participant's oropharyngeal (oral) sample result is negative, provided that none of the subsequent oral sample results are positive. We will calculate the time to clearance since Day 1.
Outcome measures
| Measure |
Niclosamide- Experimental Group
n=33 Participants
Participants received Niclosamide 2 grams by mouth daily for 7 days.
|
Control Group
n=34 Participants
Participants received placebo using the same dosing schedule as Experimental Group
|
|---|---|---|
|
Time to Respiratory Viral Clearance
|
3.39 Days
Interval 1.88 to 4.91
|
3.44 Days
Interval 2.23 to 4.65
|
SECONDARY outcome
Timeframe: Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21.Population: We evaluated efficacy of niclosamide in shortening contagious period as determined by time to fecal viral clearance. Primary analysis was based on ITT population (all randomized participants). The cumulative probability of being in clearance in each randomization group was calculated using the Kaplan-Meier estimator. The cumulative probability of clearance at day 14 between the groups was calculated using a chi-square test based on a log(- log(·)) transformation for the survival function.
Reduction in fecal viral shedding as measured by fecal PCR on days, 3, 7, 10, 14 and 21. Fecal viral clearance is defined as the first day a participant's fecal sample result is negative, provided that none of the subsequent fecal sample results are positive; calculated as the time to clearance since Day 1.
Outcome measures
| Measure |
Niclosamide- Experimental Group
n=33 Participants
Participants received Niclosamide 2 grams by mouth daily for 7 days.
|
Control Group
n=34 Participants
Participants received placebo using the same dosing schedule as Experimental Group
|
|---|---|---|
|
Time to Fecal Viral Clearance
|
6.12 Days
Interval 3.51 to 8.73
|
5.77 Days
Interval 3.3 to 8.23
|
SECONDARY outcome
Timeframe: Day 1- 30Population: Progression to Severe COVID
Defined as 1) O2 saturation \<92% on room air (in two consecutive measurements at least 2 hours apart) OR 2) requirement of hospitalization OR 3) need for artificial ventilation OR 4) death. 1) We will compare the proportion of participants who progressed to severe COVID disease between groups.
Outcome measures
| Measure |
Niclosamide- Experimental Group
n=33 Participants
Participants received Niclosamide 2 grams by mouth daily for 7 days.
|
Control Group
n=34 Participants
Participants received placebo using the same dosing schedule as Experimental Group
|
|---|---|---|
|
Number of Participants With Progression to Severe COVID-19 Disease
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1-30Population: The mean time to resolution of fever \*symptom no longer reported)
Mean time to fever resolution (symptom no longer reported).
Outcome measures
| Measure |
Niclosamide- Experimental Group
n=33 Participants
Participants received Niclosamide 2 grams by mouth daily for 7 days.
|
Control Group
n=34 Participants
Participants received placebo using the same dosing schedule as Experimental Group
|
|---|---|---|
|
Number of Days to Resolution of a Fever
|
10.2 Days
Interval 1.86 to 18.54
|
3.6 Days
Interval 2.07 to 5.13
|
Adverse Events
Niclosamide- Experimental Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Niclosamide- Experimental Group
n=33 participants at risk
Participants received Niclosamide 2 grams by mouth daily for 7 days.
|
Control Group
n=34 participants at risk
Participants received placebo using the same dosing schedule as Experimental Group
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin rash
|
9.1%
3/33 • 30 days
CTCAE V5.0
|
8.8%
3/34 • 30 days
CTCAE V5.0
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/33 • 30 days
CTCAE V5.0
|
5.9%
2/34 • 30 days
CTCAE V5.0
|
|
Gastrointestinal disorders
Nausea
|
6.1%
2/33 • 30 days
CTCAE V5.0
|
20.6%
7/34 • 30 days
CTCAE V5.0
|
Additional Information
Dorothy Dulko, PhD - Research Project Director
Tufts Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place