Trial Outcomes & Findings for Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection (NCT NCT04858425)
NCT ID: NCT04858425
Last Updated: 2024-10-08
Results Overview
Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
166 participants
Primary outcome timeframe
Day 1 to 6 weeks
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Niclosamide
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
82
|
|
Overall Study
COMPLETED
|
74
|
77
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Niclosamide
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Niclosamide in Patients With COVID-19 With Gastrointestinal Infection
Baseline characteristics by cohort
| Measure |
Niclosamide
n=84 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=82 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
145 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
77 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
151 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 to 6 weeksSerious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA).
Outcome measures
| Measure |
Niclosamide
n=84 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=82 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
SAEs
Infections and infestations
|
0 participants
|
1 participants
|
|
SAEs
Injury, poisoning and procedural complications
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Day 1 to 6 weeksProportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation.
Outcome measures
| Measure |
Niclosamide
n=84 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=82 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
TEAE
Gastrointetinal disorders
|
1 participants
|
1 participants
|
|
TEAE
Blood and lymphatic system disorders
|
0 participants
|
1 participants
|
|
TEAE
Endocrine disorders
|
0 participants
|
1 participants
|
|
TEAE
Infections and infestations
|
0 participants
|
1 participants
|
|
TEAE
Injury, poisoning and procedural complications
|
0 participants
|
1 participants
|
|
TEAE
Investigations
|
1 participants
|
1 participants
|
|
TEAE
Musculoskeletal and connective tissue disorders
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: Day 1 to 6 weeksTime to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm.
Outcome measures
| Measure |
Niclosamide
n=60 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=58 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Fecal RNA Virus Clearance
Day 4
|
8 participants
|
9 participants
|
|
Fecal RNA Virus Clearance
Day 8
|
21 participants
|
20 participants
|
|
Fecal RNA Virus Clearance
Day 15
|
40 participants
|
33 participants
|
|
Fecal RNA Virus Clearance
Day 22
|
48 participants
|
42 participants
|
|
Fecal RNA Virus Clearance
Day 29
|
51 participants
|
43 participants
|
|
Fecal RNA Virus Clearance
Day 36
|
51 participants
|
45 participants
|
|
Fecal RNA Virus Clearance
Day 43
|
52 participants
|
48 participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
Outcome measures
| Measure |
Niclosamide
n=78 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=79 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Leukocytes and Platelets)
Leukocytes
|
0.340 cells (10^9/L)
Interval -12.71 to 4.38
|
0.495 cells (10^9/L)
Interval -11.13 to 5.7
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Leukocytes and Platelets)
Platelets
|
11.5 cells (10^9/L)
Interval -196.0 to 116.0
|
3.0 cells (10^9/L)
Interval -337.0 to 148.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided. Erythrocytes
Outcome measures
| Measure |
Niclosamide
n=78 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=79 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Erythrocytes)
|
-0.250 cells 10^12/L
Interval -0.87 to 0.85
|
-0.125 cells 10^12/L
Interval -0.96 to 0.84
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided. Hemocrit (L/L)
Outcome measures
| Measure |
Niclosamide
n=78 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=79 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemocrit)
|
-0.0195 L/L
Interval -0.1 to 0.077
|
-0.0130 L/L
Interval -0.141 to 0.072
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided. Hemoglobin (g/L)
Outcome measures
| Measure |
Niclosamide
n=78 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=79 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemoglobin)
|
-4.0 g/L
Interval -30.0 to 13.0
|
-2.5 g/L
Interval -39.0 to 14.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided. Corpuscular volume (fL)
Outcome measures
| Measure |
Niclosamide
n=78 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=79 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Corpuscular Volume)
|
-0.35 fL
Interval -10.5 to 9.3
|
-0.75 fL
Interval -16.1 to 15.8
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
Outcome measures
| Measure |
Niclosamide
n=78 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=79 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium)
BUN
|
0.000 mmol/L
Interval -6.07 to 4.65
|
0.000 mmol/L
Interval -8.21 to 3.21
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium)
Glucose
|
-0.360 mmol/L
Interval -5.22 to 3.28
|
0.110 mmol/L
Interval -9.15 to 3.28
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium)
Chloride
|
2.0 mmol/L
Interval -7.0 to 9.0
|
1.0 mmol/L
Interval -9.0 to 13.0
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium)
Potassium
|
0.00 mmol/L
Interval -1.0 to 1.1
|
0.10 mmol/L
Interval -1.9 to 2.1
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium)
Sodium
|
1.0 mmol/L
Interval -6.0 to 7.0
|
0.0 mmol/L
Interval -13.0 to 7.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
Outcome measures
| Measure |
Niclosamide
n=78 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=79 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH)
Alkaline Phosphatase
|
2.0 U/L
Interval -173.0 to 26.0
|
2.0 U/L
Interval -76.0 to 49.0
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH)
AST
|
-2.5 U/L
Interval -117.0 to 98.0
|
-1.0 U/L
Interval -151.0 to 26.0
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH)
ALT
|
-3.0 U/L
Interval -70.0 to 73.0
|
-4.0 U/L
Interval -77.0 to 32.0
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH)
LDH
|
-2.0 U/L
Interval -209.0 to 157.0
|
6.0 U/L
Interval -86.0 to 102.0
|
PRIMARY outcome
Timeframe: Day 1 to Day 43Change in safety laboratory tests, including CBC, BUN, blood sugar, electrolytes, alkaline phosphatase, AST, ALT, LDH, total bilirubin, serum creatinine, from baseline to 6 weeks, the number of subjects with values low, normal, and high compared to the normal ranges pretreatment versus post-treatment will be provided.
Outcome measures
| Measure |
Niclosamide
n=78 Participants
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=79 Participants
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Bilirubin and Serum Creatinine)
Bilirubin
|
0.60 mcmol/L
Interval -10.7 to 10.1
|
1.20 mcmol/L
Interval -4.3 to 22.0
|
|
Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Bilirubin and Serum Creatinine)
Creatinine
|
0.0 mcmol/L
Interval -53.0 to 44.0
|
0.0 mcmol/L
Interval -44.0 to 27.0
|
Adverse Events
Niclosamide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Niclosamide
n=84 participants at risk
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=82 participants at risk
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Infections and infestations
Infections and infestations
|
0.00%
0/84 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/84 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Niclosamide
n=84 participants at risk
Niclosamide tablets 400 mg 3 times daily for 14 days
Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days
|
Placebo
n=82 participants at risk
Matching placebo tablets 3 times daily for 14 days
Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
1.2%
1/84 • Number of events 1 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.00%
0/84 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Endocrine disorders
Endocrine disorders
|
0.00%
0/84 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Infections and infestations
Infections and infestations
|
0.00%
0/84 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/84 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Investigations
Investigations
|
1.2%
1/84 • Number of events 1 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.00%
0/84 • 6 months
|
1.2%
1/82 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place