Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| United States Department of Defense | FED |
Not provided
Not provided
Not provided
Not provided
Subjects who have documented exposure to SARS-CoV-2 (COVID-19) will receive 4 doses of PUL-042 Inhalation Solution or 4 doses of a placebo solution by inhalation over 10 days. Subjects will be followed for the incidence and severity of COVID-19 over 28 days. Subjects will be tested for infection with SARS-CoV-2 at the beginning, middle and end of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PUL-042 Inhalation Solution | Experimental | PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3, 6, and 10 |
|
| Sterile saline for inhalation | Placebo Comparator | Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PUL-042 Inhalation Solution | Drug | 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 28 Days From the Start of Experimental Therapy. | To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement (OSCI) within 28 days from the start of experimental therapy. The OSCI to be used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement as presented below. The minimum score is 0, maximum is 8. Higher values represent a worse outcome. OSCI Scale: 0 (no evidence of infection), 1 (infected, no limitation of activities), 2 (limitation of activities), 3 (hospitalized), 4 (hospitalized & requiring oxygen), 5 (requiring high flow oxygen), 6 (requiring mechanical ventilation), 7 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of SARS-CoV-2 Infections Through Day 29 | Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit. | 28 days |
| Percentage of SARS-CoV-2 Infections Through Day 15 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Colin Broom, MD | Pulmotect, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Orange | California | 92868 | United States | ||
| Premier Urgent Care of California |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | PUL-042 Inhalation Solution | PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3, 6, and 10 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution |
| FG001 | Sterile Saline for Inhalation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jan 29, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Sterile saline for inhalation |
|
Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit. |
| 14 days |
| Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 14 Days From the Start of Experimental Therapy. | To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement (OSCI) within 14 days from the start of experimental therapy. The Ordinal Scale for Clinical Improvement (OSCI) to be used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement as presented below. Higher values represent a worse outcome. OSCI Scale: 0 (no evidence of infection), 1 (infected, no limitation of activities), 2 (limitation of activities), 3 (hospitalized), 4 (hospitalized & requiring oxygen), 5 (requiring high flow oxygen), 6 (requiring mechanical ventilation), 7 (requiring RRT, ECMO etc.), 8 (death). | 14 days |
| Number of Participants With ICU Admission | The requirement for ICU admission within 28 days from the start of experimental therapy. | 28 days |
| Number of Participants Requiring Mechanical Ventilation | The requirement for mechanical ventilation within 28 days from the start of experimental therapy. | 28 days |
| Number of Participant Deaths | All cause mortality at 28 days from the start of experimental therapy. | 28 days |
| San Bernardino |
| California |
| 92404 |
| United States |
| Clinical Research of South Florida Alliance for Multispecialty Research | Coral Gables | Florida | 33134 | United States |
| Invesclinic US LLC | Fort Lauderdale | Florida | 33308 | United States |
| Luminous Cinical Research- South Florida Urgent Care | Miami | Florida | 33136 | United States |
| Entrust Clinical Research | Miami | Florida | 33156 | United States |
| DBC Research | Tamarac | Florida | 33321 | United States |
| Affinity Clinical Research, LLC | Tampa | Florida | 33612 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Willis-Knighton Physcian Network | Bossier City | Louisiana | 71111 | United States |
| Ascension St John | Bartlesville | Oklahoma | 74006 | United States |
| Ascension St. John | Tulsa | Oklahoma | 74104 | United States |
| Invesclinic US LLC | Edinburg | Texas | 78539 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Next Level Urgent Care | Houston | Texas | 77057 | United States |
Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation |
| COMPLETED |
|
| NOT COMPLETED |
|
A total of 217 participants were randomized to the study: 7 participants were randomized but not treated, 210 (96.8%) participants were included in the ITT (Intent-to-Treat) Population and Safety Population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | PUL-042 Inhalation Solution | PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3, 6, and 10 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution |
| BG001 | Sterile Saline for Inhalation | Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation |
| 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||||
| Duration of Exposure | Mean | Standard Deviation | days |
| |||||||||||||||||
| percentage of predicted FEV1 | Mean | Standard Deviation | Percent |
|
| 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 | Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 28 Days From the Start of Experimental Therapy. | To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement (OSCI) within 28 days from the start of experimental therapy. The OSCI to be used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement as presented below. The minimum score is 0, maximum is 8. Higher values represent a worse outcome. OSCI Scale: 0 (no evidence of infection), 1 (infected, no limitation of activities), 2 (limitation of activities), 3 (hospitalized), 4 (hospitalized & requiring oxygen), 5 (requiring high flow oxygen), 6 (requiring mechanical ventilation), 7 | The population analyzed is the ITT (Intent-to-Treat) population minus one participant on PUL-042 that was excluded due to an absent baseline measurement. ITT total: 210; ITT placebo: 108; ITT PUL-042: 102 | Posted | Least Squares Mean | 90% Confidence Interval | score on a scale | 28 days |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of SARS-CoV-2 Infections Through Day 29 | Positive test for SARS-CoV-2 infection 28 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit. | Percentage of participants who had a positive result from the SARS-CoV-2 test within 28 days from the first dose of study drug was assessed using the modified ITT Set. Participants who had a missing test result or a result of "Indeterminate" at Day 29 and did not have a positive test result at Day 15 were excluded from the analysis. | Posted | Number | 90% Confidence Interval | percentage of participants | 28 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of SARS-CoV-2 Infections Through Day 15 | Positive test for SARS-CoV-2 infection 14 days from the start of experimental therapy in subjects who test negative for SARS-CoV-2 at the pre-treatment visit. | Percentage of participants who had a positive result from the SARS-CoV-2 test within 14 days from the first dose of study drug was assessed using the modified ITT Set. Participants who had a missing test result or a result of "Indeterminate" at Day 29 and did not have a positive test result at Day 15 were excluded from the analysis. | Posted | Number | 90% Confidence Interval | percentage of participants | 14 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 14 Days From the Start of Experimental Therapy. | To determine the efficacy of PUL-042 Inhalation Solution in the prevention of viral infection with SARS-CoV-2 and progression to COVID-19 in subjects: 1) who have repeated exposure to individuals with SARS-CoV-2 infection and, 2) are asymptomatic at enrollment. The primary endpoint is the severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement (OSCI) within 14 days from the start of experimental therapy. The Ordinal Scale for Clinical Improvement (OSCI) to be used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement as presented below. Higher values represent a worse outcome. OSCI Scale: 0 (no evidence of infection), 1 (infected, no limitation of activities), 2 (limitation of activities), 3 (hospitalized), 4 (hospitalized & requiring oxygen), 5 (requiring high flow oxygen), 6 (requiring mechanical ventilation), 7 (requiring RRT, ECMO etc.), 8 (death). | The population analyzed is the ITT (Intent-to-Treat) population minus one participant on PUL-042 that was excluded due to an absent baseline measurement. ITT total: 210; ITT placebo: 108; ITT PUL-042: 102 | Posted | Least Squares Mean | 90% Confidence Interval | score on a scale | 14 days |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With ICU Admission | The requirement for ICU admission within 28 days from the start of experimental therapy. | A total of 217 participants were randomized to the study: 7 participants were randomized but not treated, 210 (96.8%) participants were included in the ITT (Intent-to-Treat) Population and Safety Population. | Posted | Count of Participants | Participants | 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Requiring Mechanical Ventilation | The requirement for mechanical ventilation within 28 days from the start of experimental therapy. | A total of 217 participants were randomized to the study: 7 participants were randomized but not treated, 210 (96.8%) participants were included in the ITT (Intent-to-Treat) Population and Safety Population. | Posted | Count of Participants | Participants | 28 days |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participant Deaths | All cause mortality at 28 days from the start of experimental therapy. | A total of 217 participants were randomized to the study: 7 participants were randomized but not treated, 210 (96.8%) participants were included in the ITT (Intent-to-Treat) Population and Safety Population. | Posted | Count of Participants | Participants | 28 days |
|
|
full treatment period (29 days)
A total of 217 participants were randomized to the study: 7 participants were randomized but not treated, 210 (96.8%) participants were included in the ITT (Intent-to-Treat) Population and Safety Population.
Adverse events are collected by organ system, irrespective of causality.
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 | PUL-042 Inhalation Solution | PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3, 6, and 10 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution | 0 | 102 | 0 | 102 | 28 | 102 |
| EG001 | Sterile Saline for Inhalation | Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation | 0 | 108 | 0 | 108 | 10 | 108 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brenton Scott, President & COO | Pulmotect, Inc. | 713-579-9226 | bscott@pulmotect.com |
| Feb 21, 2023 |
| Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2021 | Feb 22, 2023 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| >=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 |
|
|
|
| OG001 | Sterile Saline for Inhalation | Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation |
|
|
|
|
|