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The termination of the study was a decision based on topline data analysis (no efficacy as per Day 43) of the study data.
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This is a 2-part, 2-arm, Phase 2 , multicentre, randomized, double-blind, placebo-controlled study in adults with COVID-19 with gastrointestinal infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niclosamide | Experimental | Niclosamide tablets 400 mg 3 times daily for 14 days |
|
| Placebo | Placebo Comparator | Matching placebo tablets 3 times daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niclosamide | Drug | Niclosamide tablets 400 mg 3 times daily for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| SAEs | Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA). | Day 1 to 6 weeks |
| TEAE | Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation. | Day 1 to 6 weeks |
| Fecal RNA Virus Clearance | Time to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm. | Day 1 to 6 weeks |
| Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Leukocytes and Platelets) | Change 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. | Day 1 to Day 43 |
| Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Erythrocytes) | Change 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 | Day 1 to Day 43 |
| Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemocrit) | Change 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Alabama Research | Birmingham | Alabama | 35209 | United States | ||
| Midland Florida Clinical Research Center, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Niclosamide | Niclosamide tablets 400 mg 3 times daily for 14 days Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days |
| FG001 | Placebo | Matching placebo tablets 3 times daily for 14 days Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2021 | Mar 21, 2024 |
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| Placebo |
| Drug |
Matched placebo tablets 400 mg 3 times daily for 14 days |
|
| Day 1 to Day 43 |
| Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemoglobin) | Change 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) | Day 1 to Day 43 |
| Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Corpuscular Volume) | Change 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) | Day 1 to Day 43 |
| Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium) | Change 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. | Day 1 to Day 43 |
| Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH) | Change 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. | Day 1 to Day 43 |
| Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Bilirubin and Serum Creatinine) | Change 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. | Day 1 to Day 43 |
| DeLand |
| Florida |
| 32720-0920 |
| United States |
| New Generation Medical Research | Hialeah | Florida | 33016-1895 | United States |
| LCC Medical Reserach Institute, LLC | Miami | Florida | 33126 | United States |
| Westchester General Hospital | Miami | Florida | 33155-2805 | United States |
| Miami Clinical Research | Miami | Florida | 33155 | United States |
| P & S Research, LLC | Miami | Florida | 33175-2912 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| IACT Health - Roswell | Columbus | Georgia | 30076 | United States |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | United States |
| Homestead Associates in Research | Homestead Meadows | Texas | 33032-8225 | United States |
| SMS Clinical Research LLC | Mesquite | Texas | 75149 | United States |
| Tranquil Research | Webster | Texas | 77598 | United States |
| Yashoda Hospital | Secunderabad | Andhra Pradesh | 50003 | India |
| SSG Hospital and Medical Institute | Vadodara | Gujarat | 390001 | India |
| GMERS Medical College and Hospital | Vadodara | Gujarat | 390021 | India |
| Noble Hospital Private Limited | Pune | Maharashtra | 411013 | India |
| Sir Ganga Ram Hospital | Nagar | New Delhi | 110060 | India |
| Maharaja Agrasen Superspeciality Hospital, Jaipur | Jaipur | Rajasthan | 302039 | India |
| Malla Reddy Narayana Multispecialty Hospital | Hyderabad | Telangana | 500055 | India |
| Communal Non-Commercial Medical Enterprise "Likarnya Prydniprovska" | Kremenchuk | Poltava Oblast | 39600 | Ukraine |
| Municipal Non-profit Enterprise "City Clinical Hospital # 4" of Dnipro City Council | Dnipro | 41102 | Ukraine |
| Municipal Non-profit Enterprise Central City Clinical Hospital of Ivano-Frankivsk City Council | Ivano-Frankivsk | 76025 | Ukraine |
| Municipal Non-Profit Enterprise City Clinical Hospital 13 of Kharkiv Regional Council | Kharkiv | 61124 | Ukraine |
| Private Enterprise Private Manufacturing Company Acinus | Kropyvnytskyi | 25006 | Ukraine |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Niclosamide | Niclosamide tablets 400 mg 3 times daily for 14 days Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days |
| BG001 | Placebo | Matching placebo tablets 3 times daily for 14 days Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | SAEs | Serious adverse event (SAE) coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA). | Posted | Number | participants | Day 1 to 6 weeks |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | TEAE | Proportion of patients with Treatment Emergent Adverse Events (TEAE) leading to study drug discontinuation. | Posted | Number | participants | Day 1 to 6 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Fecal RNA Virus Clearance | Time to fecal viral RNA clearance (stool sample) assessed by RT-qPCR in the niclosamide arm compared to the placebo arm. | Posted | Number | participants | Day 1 to 6 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Primary | Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Leukocytes and Platelets) | Change 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. | Posted | Median | Full Range | cells (10^9/L) | Day 1 to Day 43 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Erythrocytes) | Change 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 | Posted | Median | Full Range | cells 10^12/L | Day 1 to Day 43 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemocrit) | Change 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) | Posted | Median | Full Range | L/L | Day 1 to Day 43 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Hemoglobin) | Change 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) | Posted | Median | Full Range | g/L | Day 1 to Day 43 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Corpuscular Volume) | Change 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) | Posted | Median | Full Range | fL | Day 1 to Day 43 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically BUN, Glucose, Chloride, Potassium, and Sodium) | Change 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. | Posted | Median | Full Range | mmol/L | Day 1 to Day 43 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Alkaline Phosphatase, AST, ALT, and LDH) | Change 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. | Posted | Median | Full Range | U/L | Day 1 to Day 43 |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Safety Laboratory Tests Including CBC, BUN, Blood Sugar, Electrolytes (Specifically Bilirubin and Serum Creatinine) | Change 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. | Posted | Median | Full Range | mcmol/L | Day 1 to Day 43 |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Niclosamide | Niclosamide tablets 400 mg 3 times daily for 14 days Niclosamide: Niclosamide tablets 400 mg 3 times daily for 14 days | 0 | 84 | 0 | 84 | 1 | 84 |
| EG001 | Placebo | Matching placebo tablets 3 times daily for 14 days Placebo: Matched placebo tablets 400 mg 3 times daily for 14 days | 0 | 82 | 2 | 82 | 1 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | Non-systematic Assessment |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Endocrine disorders | Endocrine disorders | Non-systematic Assessment |
| ||
| Infections and infestations | Infections and infestations | Non-systematic Assessment |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Investigations | Investigations | Non-systematic Assessment |
| ||
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Regulatory, QA & Compliance | First Wave BioPharma | 19194491484 | AChandler@FirstWaveBio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 14, 2022 | Mar 21, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009534 | Niclosamide |
| ID | Term |
|---|---|
| D012458 | Salicylanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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