The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection
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ClinicalTrials.gov Identifier: NCT04312997 |
Recruitment Status :
Completed
First Posted : March 18, 2020
Last Update Posted : July 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: PUL-042 Inhalation Solution Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 101 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection |
Actual Study Start Date : | June 16, 2020 |
Actual Primary Completion Date : | July 2, 2021 |
Actual Study Completion Date : | July 2, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: PUL-042 Inhalation Solution
PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3 and 6
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Drug: PUL-042 Inhalation Solution
20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) |
Placebo Comparator: Sterile saline for inhalation
Sterile saline for Inhalation given by nebulization on Study Days 1, 3 and 6
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Drug: Placebo
Sterile saline for inhalation |
- Severity of COVID-19 [ Time Frame: 28 days ]
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 is the difference in the proportion 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.
The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.
- SARS-CoV-2 infection [ Time Frame: 28 days ]SARS-Co-V-2 positivity up to 28 days from the start of experimental therapy
- Severity of COVID-19 over 14 days [ Time Frame: 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.
The Ordinal Scale for Clinical Improvement is a nine point scale (0-8) with 0 being no clinical or virological evidence of infection and 8 being death.
- Severity of COVID-19 symptoms [ Time Frame: 28 days ]
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.
- Severity of COVID-19 symptoms [ Time Frame: 28 days ]To assess the progression of COVID-19 severity during the study as measured by the Ordinal Scale for Clinical Improvement.
- ICU admission [ Time Frame: 28 days ]The requirement for ICU admission within 28 days from the start of the experimental therapy.
- Mechanical Ventilation [ Time Frame: 28 days ]The requirement for mechanical ventilation within 28 days from the start of the experimental therapy.
- Mortality [ Time Frame: 28 days ]All cause mortality at 28 days from the start of experimental therapy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must have a positive test for SARS-CoV-2.
- COVID-19 signs and symptoms such as (fever, cough, shortness of breath or fatigue) with onset within the 7 days prior to Screening
- Subjects should be Ordinal Scale for Clinical Improvement score of 4 or less.
- Subjects receiving oxygen should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs.
- Subjects can be receiving standard of care (SOC) for COVID-19, this includes marketed therapies or therapies with Emergency Use Authorization (EUA) for COVID-19 treatment.
- Subject's spirometry (FEV1 and forced vital capacity [FVC]) must be ≥70% of predicted value.
- If female, the subject must be surgically sterile or ≥ 1 year postmenopausal. If of child-bearing potential (including being < 1years postmenopausal) and, if participating in sexual activity that may lead to pregnancy, the subject agrees to use an effective dual method of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study.
- If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.
- If male, must be surgically sterile or, if not surgically sterile and if participating in sexual activities that may lead to pregnancy, be willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study.
- Must have the ability to understand and give informed consent.
Exclusion Criteria:
- No documented infection with SARS-CoV-2.
- Patients who are in respiratory distress or require high flow oxygen, non-invasive ventilation or mechanical ventilation (Ordinal Scale for Clinical Improvement >4) or with pulse oximetry less than 93% on oxygen with a flow rate of 3 liters per minute or less by nasal prongs at the time of screening.
- Known history of chronic pulmonary disease (e.g., asthma [including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.
- Exposure to any investigational therapy (defined as any agent not currently marketed or without EUA) at the time of or within 30 days prior to the Screening Visit.
- Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of trial endpoints

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04312997
United States, California | |
University of California Irvine | |
Orange, California, United States, 92868 | |
Premeir Urgent Care of California | |
San Bernardino, California, United States, 92404 | |
United States, Florida | |
Clinical Research of South Florida Alliance for Multispecialty Research | |
Coral Gables, Florida, United States, 33134 | |
Invesclinic US LLC | |
Fort Lauderdale, Florida, United States, 33308 | |
DBC Research Corp. | |
Tamarac, Florida, United States, 33321 | |
Affinity Clinical Research, LLC | |
Tampa, Florida, United States, 33612 | |
United States, Kentucky | |
St. Elizabeth Healthcare | |
Edgewood, Kentucky, United States, 41017 | |
United States, Oklahoma | |
Ascension St. John | |
Bartlesville, Oklahoma, United States, 74006 | |
Ascension St. John | |
Tulsa, Oklahoma, United States, 74104 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Next Level Urgent Care | |
Houston, Texas, United States, 77057 |
Study Director: | Colin Broom, MD | Pulmotect, Inc. |
Responsible Party: | Pulmotect, Inc. |
ClinicalTrials.gov Identifier: | NCT04312997 |
Other Study ID Numbers: |
PUL-042-502 |
First Posted: | March 18, 2020 Key Record Dates |
Last Update Posted: | July 16, 2021 |
Last Verified: | July 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Infections Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections |
Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Pam2CSK4 acetate and ODN M362 combination Respiratory System Agents |