Trial Outcomes & Findings for The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection (NCT NCT04312997)

Last Updated: 2023-04-18

Results Overview

To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection, and 2) if receiving oxygen, should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs (Ordinal Scale for Clinical Improvement 4 or less) at the time of enrollment. The primary endpoint analysis is the evaluation of the number of patients with clinically meaningful worsening of COVID-19 within 28 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement (OSCI). The OSCI used in this study is derived from a draft scale proposed by the World Health Organization for clinical improvement. Higher values represent a worse outcome. The OSCI is a nine-point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

101 participants

Primary outcome timeframe

28 days

Results posted on

2023-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	PUL-042 Inhalation Solution PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Overall Study STARTED	51	50
Overall Study COMPLETED	45	47
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PUL-042 Inhalation Solution n=49 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=50 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=93 Participants	49 Participants n=4 Participants	93 Participants n=27 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Age, Continuous	42.2 years STANDARD_DEVIATION 15.89 • n=93 Participants	43 years STANDARD_DEVIATION 11.86 • n=4 Participants	42.6 years STANDARD_DEVIATION 13.93 • n=27 Participants
Sex: Female, Male Female	24 Participants n=93 Participants	33 Participants n=4 Participants	57 Participants n=27 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	17 Participants n=4 Participants	42 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=93 Participants	30 Participants n=4 Participants	59 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=93 Participants	20 Participants n=4 Participants	40 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	45 Participants n=93 Participants	42 Participants n=4 Participants	87 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Region of Enrollment United States	49 participants n=93 Participants	50 participants n=4 Participants	99 participants n=27 Participants
BMI	28.55 kg/m^2 STANDARD_DEVIATION 7.176 • n=93 Participants	28.50 kg/m^2 STANDARD_DEVIATION 7.594 • n=4 Participants	28.52 kg/m^2 STANDARD_DEVIATION 7.354 • n=27 Participants
Time from Symptom Onset to Day 1 Treatment	6.3 days STANDARD_DEVIATION 1.96 • n=93 Participants	5.9 days STANDARD_DEVIATION 1.92 • n=4 Participants	6.1 days STANDARD_DEVIATION 1.94 • n=27 Participants
FEV1 % Predicted	88.5 Percent n=93 Participants	94.2 Percent n=4 Participants	91.4 Percent n=27 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The number of Baseline Participants (99) differs from the numbers in the Participant Flow (101) as two participants were randomized but not treated. The ITT (Intent-to-treat) population is 99 total (49 for PUL-042, 50 for placebo).

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=49 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=50 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Number of Participants With Worsening of COVID-19 Within 28 Days	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Analysis Population: number of ITT (Intent-to-Treat) participants with non-missing test results (Positive or Negative) at the end of the study or early termination visit

SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=41 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=45 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Number of Participants With Positive SARS-CoV-2 Test Results at the End of Study	8 Participants	9 Participants

SECONDARY outcome

Timeframe: 14 days

To determine the difference in the proportion of COVID-19 patients with clinically meaningful worsening of COVID-19 within 14 days from the start of experimental therapy, as indicated by an increase of at least 2 points on the Ordinal Scale for Clinical Improvement (OSCI). The OSCI is a nine-point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=49 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=50 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Number of Participants With Worsening of COVID-19 Over 14 Days	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Analyzed was the number of ITT participants (total 99) with at least 1 symptom score of \>=1 for one symptom (total 92).

To assess the progression of COVID-19 severity during the study as measured by the SARS-CoV-2 Symptom Score. The SARS-CoV-2 Symptom Score measures 3 elements on a 0-3 scale (cough, shortness of breath or difficulty breathing, and muscle aches or fatigue) ranging from 0 for none to 3 for severe. The fourth element is fever and it is rated on a 0-4 scale with 0 being no fever and 4 being life-threatening. The time to respiratory symptom improvement is measured in days. Time to improvement of symptoms was prospectively defined as the time from an initial symptom score of ≥1 to a reduction of ≥1 point. The time to improvement of symptoms was evaluated for each individual symptom listed above.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=45 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=47 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Time to COVID-19 Symptom Improvement: Respiratory Symptoms	6 Days Interval 4.0 to 7.0	9 Days Interval 5.0 to 11.0

SECONDARY outcome

Timeframe: 28 days

Population: Analyzed was the number of ITT participants (total 99) with at least 1 symptom score of \>=1 for one symptom (total 92).

The time to resolution of COVID-19 symptoms during the study was measured by the SARS-CoV-2 Symptom Score: The SARS-CoV-2 Symptom Score measures 3 elements on a 0-3 scale (cough, shortness of breath or difficulty breathing, and muscle aches or fatigue) ranging from 0 for none to 3 for severe. The fourth element is fever and it is rated on a 0-4 scale with 0 being no fever and 4 being life-threatening. The time to the first occurrence of resolution of symptoms (in days) was defined as the time from the first symptom score of ≥1 to a symptom score of 0.

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=45 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=47 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Time to Resolution of COVID-19 Symptoms	11 Days Interval 6.0 to 15.0	11 Days Interval 9.0 to 15.0

SECONDARY outcome

Timeframe: 28 days

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

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=49 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=50 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Number of Participants Requiring ICU Admission	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 28 days

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

Outcome measures

Outcome measures
Measure	PUL-042 Inhalation Solution n=49 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=50 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 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=49 Participants PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=50 Participants Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Number of Participant Death	0 Participants	0 Participants

Adverse Events

PUL-042 Inhalation Solution

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Sterile Saline for Inhalation

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PUL-042 Inhalation Solution n=48 participants at risk PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=51 participants at risk Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Infections and infestations COVID-19	2.1% 1/48 • Subjects will participate for 28 days. Reporting is done by organ system, irrespective of causality. The Safety Population Set (99) was defined as all randomized participants (101) who received at least one dose of experimental treatment (99) - PUL-042 (49) or Placebo (50), but participants were categorized based on the treatment actually received rather than as randomized. One subject was randomized to PUL-042 but incorrectly received Placebo, resulting in 48 participants receiving PUL-042 and 51 participants receiving Placebo.	3.9% 2/51 • Subjects will participate for 28 days. Reporting is done by organ system, irrespective of causality. The Safety Population Set (99) was defined as all randomized participants (101) who received at least one dose of experimental treatment (99) - PUL-042 (49) or Placebo (50), but participants were categorized based on the treatment actually received rather than as randomized. One subject was randomized to PUL-042 but incorrectly received Placebo, resulting in 48 participants receiving PUL-042 and 51 participants receiving Placebo.

Other adverse events

Other adverse events
Measure	PUL-042 Inhalation Solution n=48 participants at risk PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6 PUL-042 Inhalation Solution: 20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)	Sterile Saline for Inhalation n=51 participants at risk Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6 Placebo: Sterile saline for inhalation
Gastrointestinal disorders Nausea	6.2% 3/48 • Subjects will participate for 28 days. Reporting is done by organ system, irrespective of causality. The Safety Population Set (99) was defined as all randomized participants (101) who received at least one dose of experimental treatment (99) - PUL-042 (49) or Placebo (50), but participants were categorized based on the treatment actually received rather than as randomized. One subject was randomized to PUL-042 but incorrectly received Placebo, resulting in 48 participants receiving PUL-042 and 51 participants receiving Placebo.	0.00% 0/51 • Subjects will participate for 28 days. Reporting is done by organ system, irrespective of causality. The Safety Population Set (99) was defined as all randomized participants (101) who received at least one dose of experimental treatment (99) - PUL-042 (49) or Placebo (50), but participants were categorized based on the treatment actually received rather than as randomized. One subject was randomized to PUL-042 but incorrectly received Placebo, resulting in 48 participants receiving PUL-042 and 51 participants receiving Placebo.
General disorders Chest discomfort	4.2% 2/48 • Subjects will participate for 28 days. Reporting is done by organ system, irrespective of causality. The Safety Population Set (99) was defined as all randomized participants (101) who received at least one dose of experimental treatment (99) - PUL-042 (49) or Placebo (50), but participants were categorized based on the treatment actually received rather than as randomized. One subject was randomized to PUL-042 but incorrectly received Placebo, resulting in 48 participants receiving PUL-042 and 51 participants receiving Placebo.	0.00% 0/51 • Subjects will participate for 28 days. Reporting is done by organ system, irrespective of causality. The Safety Population Set (99) was defined as all randomized participants (101) who received at least one dose of experimental treatment (99) - PUL-042 (49) or Placebo (50), but participants were categorized based on the treatment actually received rather than as randomized. One subject was randomized to PUL-042 but incorrectly received Placebo, resulting in 48 participants receiving PUL-042 and 51 participants receiving Placebo.
General disorders Chills	4.2% 2/48 • Subjects will participate for 28 days. Reporting is done by organ system, irrespective of causality. The Safety Population Set (99) was defined as all randomized participants (101) who received at least one dose of experimental treatment (99) - PUL-042 (49) or Placebo (50), but participants were categorized based on the treatment actually received rather than as randomized. One subject was randomized to PUL-042 but incorrectly received Placebo, resulting in 48 participants receiving PUL-042 and 51 participants receiving Placebo.	0.00% 0/51 • Subjects will participate for 28 days. Reporting is done by organ system, irrespective of causality. The Safety Population Set (99) was defined as all randomized participants (101) who received at least one dose of experimental treatment (99) - PUL-042 (49) or Placebo (50), but participants were categorized based on the treatment actually received rather than as randomized. One subject was randomized to PUL-042 but incorrectly received Placebo, resulting in 48 participants receiving PUL-042 and 51 participants receiving Placebo.

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