Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Study of ANA001 in Moderate and Severe COVID-19 Patients
This is a 2 part, Phase 2/3 multi-center, double blinded, placebo-controlled study to assess the safety, tolerability, and efficacy of oral niclosamide (ANA001) in moderate and severe hospitalized COVID-19 patients compared to placebo.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANA001 | Experimental | Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding. |
|
| Matching Placebo | Placebo Comparator | Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niclosamide | Drug | Niclosamide is an antihelmintic with in-vitro antiviral activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Experiencing TEAEs | Incidence of Treatment Emergent Adverse Events (TEAEs) | Randomization to Day 60 |
| Number of Subjects Experiencing TESAEs | Incidence of Treatment Emergent Serious Adverse Events (TESAEs) | Randomization to Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Time to Hospital Discharge | Median time until patient is discharged from hospital. Discharge is defined as a score of 1 or 2 in the WHO Ordinal Scale for Clinical Improvement. This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death". | Randomization to Day 60 |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Hospitalized but no longer requires ongoing inpatient care (i.e., discharge is anticipated in ≤24 hours)
Patient is not anticipated to survive >48 hours OR is under palliative care
Evidence of critical illness, defined by at least 1 of the following:
Respiratory failure requiring at least 1 of the following:
Shock (defined by systolic blood pressure (BP) <90 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), OR
Multi-organ dysfunction/failure
Severe central nervous system (CNS) conditions
Chronic kidney disease requiring dialysis
Known allergy to the study drug or salicylate containing medications.
Suspected and/or confirmed pregnancy or breastfeeding
Current or planned participation in any other clinical trial of a treatment being developed under a US investigational new drug (IND) or emergency use authorization (EUA).
Patients receiving chemotherapeutic agents and/or immunomodulators (including monoclonal antibodies (Mabs) or plasma transfusions) for chronic disease conditions.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doug Rank, MD | NeuroBo Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helen Keller Hospital | Sheffield | Alabama | 35660 | United States | ||
| University of California, Irvine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ANA001 | Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding. Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity |
| FG001 | Matching Placebo | Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration. Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ANA001 | Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding. Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Number of Subjects Experiencing TEAEs | Incidence of Treatment Emergent Adverse Events (TEAEs) | Safety Analysis Set: Includes all randomized participants, classified according to the actual treatment received regardless of randomization assignment, who received any amount of study drug and have at least one post-baseline safety evaluation. This is the analysis population for all planned safety analyses. | Posted | Count of Participants | Participants | Randomization to Day 60 |
|
TEAEs are any adverse events that emerge on or after first dosing and up to 28 days after last dose during follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ANA001 | Subjects in the ANA001 treatment arm will receive 1,000 mg (4 capsules; 250 mg each) by mouth twice per day for 7 consecutive days with a meal. If the participant requires mechanical ventilation over the course of the study, ANA001 may be administered via nasogastric (NG), percutaneous endoscopic gastrostomy (PEG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding. Niclosamide: Niclosamide is an antihelmintic with in-vitro antiviral activity |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Septic shock | Infections and infestations | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Vice President Clinical Operations | Robert Homolka | 8572991035 | bob.homolka@neurobopharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2022 | Aug 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 30, 2022 | Aug 6, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007239 | Infections |
| D012128 | Respiratory Distress Syndrome |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D018352 | Coronavirus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D009534 | Niclosamide |
| ID | Term |
|---|---|
| D012458 | Salicylanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients |
|
|
| Median Time to 2-point Improvement WHO Clinical Improvement Scale |
Median Time to 2-point Improvement in WHO Ordinal Scale for Clinical Improvement. This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death" |
| Randomization to Day 60 |
| Median Time to Resolution of COVID-19 Symptoms | Median time (in days) to resolution of subjective symptoms assessed by the Investigator to be potentially due to COVID-19 including: fever, cough (productive or non-productive), sore throat, malaise, headache, muscle pain, gastrointestinal symptoms (i.e., nausea, vomiting, or diarrhea), shortness of breath (with or without exertion), and respiratory distress | Randomization to Day 60 |
| Median Time to Time-to-Viral Load Undetectable | Median number of days to viral load undetectable by nasopharyngeal (NP) swab | Randomization to Day 60 |
| AUC 0-t (h*ng/mL) | Area under the drug concentration (h*ng/mL) (AUC) vs time curve on Days 1 and 2 | Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose. |
| Cmax (ng/mL) | Maximum post dose plasma drug concentration on [Cmax (ng/mL)] Days 1 and 2 | Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose. |
| Tmax (h) | Time to maximum post dose plasma drug concentration on [Tmax (h)] Days 1 and 2 | Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose. |
| Irvine |
| California |
| 92697 |
| United States |
| Baptist Health Research Institute | Jacksonville | Florida | 32207 | United States |
| AdventHealth Tampa | Tampa | Florida | 33613 | United States |
| University of Missouri Health Care | Columbia | Missouri | 65212 | United States |
| Caroline Institute for Clinical Research | Fayetteville | North Carolina | 28303 | United States |
| Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | United States |
| Providence Regional Medical Center Everett | Everett | Washington | 92801 | United States |
| Adverse Event |
|
| BG001 | Matching Placebo | Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration. Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Days from First COVID-19 Symptom to Randomisation | Date of Randomization minus the Date of the first COVID-19 symptom | Mean | Standard Deviation | Days |
|
| Baseline WHO Ordinal Scale for Clinical Improvement | This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death". | Count of Participants | Participants |
|
| OG001 | Matching Placebo | Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration. Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients |
|
|
| Primary | Number of Subjects Experiencing TESAEs | Incidence of Treatment Emergent Serious Adverse Events (TESAEs) | Safety Analysis Set: Includes all randomized participants, classified according to the actual treatment received regardless of randomization assignment, who received any amount of study drug and have at least one post-baseline safety evaluation. This is the analysis population for all planned safety analyses. | Posted | Count of Participants | Participants | Randomization to Day 60 |
|
|
|
| Secondary | Median Time to Hospital Discharge | Median time until patient is discharged from hospital. Discharge is defined as a score of 1 or 2 in the WHO Ordinal Scale for Clinical Improvement. This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death". | Posted | Median | 95% Confidence Interval | Days | Randomization to Day 60 |
|
|
|
|
| Secondary | Median Time to 2-point Improvement WHO Clinical Improvement Scale | Median Time to 2-point Improvement in WHO Ordinal Scale for Clinical Improvement. This is a 9 point ordinal scale with 0 indicating "No clinical or virological evidence of infection" and 8 indicating "Death" | Posted | Median | Inter-Quartile Range | Days | Randomization to Day 60 |
|
|
|
|
| Secondary | Median Time to Resolution of COVID-19 Symptoms | Median time (in days) to resolution of subjective symptoms assessed by the Investigator to be potentially due to COVID-19 including: fever, cough (productive or non-productive), sore throat, malaise, headache, muscle pain, gastrointestinal symptoms (i.e., nausea, vomiting, or diarrhea), shortness of breath (with or without exertion), and respiratory distress | Posted | Median | 95% Confidence Interval | Days | Randomization to Day 60 |
|
|
|
| Secondary | Median Time to Time-to-Viral Load Undetectable | Median number of days to viral load undetectable by nasopharyngeal (NP) swab | Posted | Median | 95% Confidence Interval | Days | Randomization to Day 60 |
|
|
|
| Secondary | AUC 0-t (h*ng/mL) | Area under the drug concentration (h*ng/mL) (AUC) vs time curve on Days 1 and 2 | Day 1 data only available for 7 subjects | Posted | Mean | Standard Deviation | h*ng/mL | Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose. |
|
|
|
| Secondary | Cmax (ng/mL) | Maximum post dose plasma drug concentration on [Cmax (ng/mL)] Days 1 and 2 | Day 1 data only available for 7 subjects | Posted | Mean | Standard Deviation | ng/mL | Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose. |
|
|
|
| Secondary | Tmax (h) | Time to maximum post dose plasma drug concentration on [Tmax (h)] Days 1 and 2 | Day 1 data only available for 7 subjects | Posted | Mean | Standard Deviation | (h) | Pre- dose (within 30mins prior to each dose) and 1, 4 and 8 hours after each dose. |
|
|
|
| 2 |
| 22 |
| 3 |
| 22 |
| 16 |
| 22 |
| EG001 | Matching Placebo | Subjects in the comparator arm will receive matching placebo (hydroxypropylmethylcellulose (HPMC)) (4 capsules, by mouth twice a day) for the 7-day treatment duration. Placebo: Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients | 3 | 23 | 6 | 23 | 12 | 23 |
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Shock haemorrhagic | Vascular disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | Non-systematic Assessment |
|
| Mania | Psychiatric disorders | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypermagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperferritinaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Fluid Overload | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperalbuminaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Metabolic Acidosis | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Otitis Media | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| COVID-19 pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Oral candiasis | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Metabolic encephalopathy | Nervous system disorders | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Nephrogenic anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Coagulopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Groin Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumomediatinum | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Respiratory alkalosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| C-reactive protein increases | Investigations | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | Non-systematic Assessment |
|
| Fibrin D dimer increased | Investigations | Non-systematic Assessment |
|
| Granulocyte count increased | Investigations | Non-systematic Assessment |
|
| Immature granulocyte percentage increased | Investigations | Non-systematic Assessment |
|
| Klebsiella test positive | Investigations | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
|
| End stage renal disease | Renal and urinary disorders | Non-systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | Non-systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| subcutaneous emphysema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Respiratory Acidosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D003333 |
| Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012457 |
| Salicylamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
|
|
|