Trial Outcomes & Findings for The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 (NCT NCT04313023)

Last Updated: 2023-05-17

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

217 participants

Primary outcome timeframe

28 days

Results posted on

2023-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	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	Sterile Saline for Inhalation Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
Overall Study STARTED	108	109
Overall Study COMPLETED	100	107
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PUL-042 Inhalation Solution n=102 Participants 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	Sterile Saline for Inhalation n=108 Participants Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation	Total n=210 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=5 Participants	99 Participants n=7 Participants	190 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	48.6 years STANDARD_DEVIATION 13.64 • n=5 Participants	45.6 years STANDARD_DEVIATION 14.4 • n=7 Participants	47.1 years STANDARD_DEVIATION 14.09 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	60 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	48 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	68 Participants n=5 Participants	78 Participants n=7 Participants	146 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	83 Participants n=5 Participants	92 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants	108 participants n=7 Participants	210 participants n=5 Participants
BMI	29.29 kg/m^2 STANDARD_DEVIATION 5.619 • n=5 Participants	29.02 kg/m^2 STANDARD_DEVIATION 5.099 • n=7 Participants	29.15 kg/m^2 STANDARD_DEVIATION 5.347 • n=5 Participants
Duration of Exposure	29.7 days STANDARD_DEVIATION 44.28 • n=5 Participants	33.4 days STANDARD_DEVIATION 57.94 • n=7 Participants	31.6 days STANDARD_DEVIATION 51.54 • n=5 Participants
percentage of predicted FEV1	94.86 Percent STANDARD_DEVIATION 18.277 • n=5 Participants	94.99 Percent STANDARD_DEVIATION 17.487 • n=7 Participants	94.93 Percent STANDARD_DEVIATION 17.832 • n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: 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

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=101 Participants 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	Sterile Saline for Inhalation n=108 Participants Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
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.	0.028 score on a scale Interval -0.004 to 0.06	0.048 score on a scale Interval 0.017 to 0.079

SECONDARY outcome

Timeframe: 28 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=94 Participants 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	Sterile Saline for Inhalation n=98 Participants Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
Percentage of SARS-CoV-2 Infections Through Day 29	3.37 percentage of participants Interval 0.92 to 8.48	3.23 percentage of participants Interval 0.88 to 8.13

SECONDARY outcome

Timeframe: 14 days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=94 Participants 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	Sterile Saline for Inhalation n=98 Participants Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
Percentage of SARS-CoV-2 Infections Through Day 15	2.17 percentage of participants Interval 0.39 to 6.69	2.13 percentage of participants Interval 0.38 to 6.55

SECONDARY outcome

Timeframe: 14 days

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).

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=101 Participants 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	Sterile Saline for Inhalation n=108 Participants Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
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.	0.018 score on a scale Interval -0.012 to 0.048	0.048 score on a scale Interval 0.019 to 0.077

SECONDARY outcome

Timeframe: 28 days

Population: 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.

The requirement for ICU admission within 28 days from the start of experimental therapy.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=102 Participants 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	Sterile Saline for Inhalation n=108 Participants Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
Number of Participants With ICU Admission	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

The requirement for mechanical ventilation within 28 days from the start of experimental therapy.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=102 Participants 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	Sterile Saline for Inhalation n=108 Participants Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
Number of Participants Requiring Mechanical Ventilation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

All cause mortality at 28 days from the start of experimental therapy.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=102 Participants 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	Sterile Saline for Inhalation n=108 Participants Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
Number of Participant Deaths	0 Participants	0 Participants

Adverse Events

PUL-042 Inhalation Solution

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Sterile Saline for Inhalation

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PUL-042 Inhalation Solution n=102 participants at risk 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	Sterile Saline for Inhalation n=108 participants at risk Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10 Placebo: Sterile saline for inhalation
Gastrointestinal disorders Nausea	0.98% 1/102 • 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.	0.93% 1/108 • 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.
General disorders Chest discomfort	2.0% 2/102 • 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.	0.00% 0/108 • 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.
General disorders Chills	4.9% 5/102 • 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.	0.00% 0/108 • 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.
General disorders Fatigue	0.98% 1/102 • 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.	0.93% 1/108 • 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.
General disorders Pain	2.0% 2/102 • 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.	0.00% 0/108 • 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.
General disorders Pyrexia	2.0% 2/102 • 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.	0.00% 0/108 • 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.
Musculoskeletal and connective tissue disorders Myalgia	2.0% 2/102 • 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.	0.00% 0/108 • 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.
Nervous system disorders Dizziness	2.0% 2/102 • 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.	0.93% 1/108 • 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.
Nervous system disorders Headache	2.0% 2/102 • 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.	0.00% 0/108 • 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.
Vascular disorders Hypertension	3.9% 4/102 • 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.	0.93% 1/108 • 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.
Respiratory, thoracic and mediastinal disorders Cough	5.9% 6/102 • 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.	3.7% 4/108 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.98% 1/102 • 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.	0.93% 1/108 • 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.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.98% 1/102 • 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.	0.93% 1/108 • 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.
Respiratory, thoracic and mediastinal disorders Throat irritation	2.9% 3/102 • 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.	0.00% 0/108 • 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.

Additional Information

Dr. Brenton Scott, President & COO

Pulmotect, Inc.

Phone: 713-579-9226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER