The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
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ClinicalTrials.gov Identifier: NCT04313023 |
Recruitment Status :
Completed
First Posted : March 18, 2020
Last Update Posted : September 2, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Drug: PUL-042 Inhalation Solution Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 217 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2 |
Actual Study Start Date : | June 9, 2020 |
Actual Primary Completion Date : | July 31, 2021 |
Actual Study Completion Date : | July 31, 2021 |

Arm | Intervention/treatment |
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Experimental: PUL-042 Inhalation Solution
PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3, 6, and 10
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Drug: PUL-042 Inhalation Solution
20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution |
Placebo Comparator: Sterile saline for inhalation
Sterile saline for inhalation given by nebulization on Study Days 1, 3, 6, and 10
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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 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 within 28 days from the start of experimental therapy.
- Incidence of SARS-CoV-2 infection [ Time Frame: 28 days ]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
- Incidence of SARS-CoV-2 infection [ Time Frame: 14 days ]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
- Severity of COVID-19 [ Time Frame: 14 days ]The severity of COVID-19 as measured by the maximum difference from the baseline value in the Ordinal Scale for Symptom Improvement within 14 days from the start of experimental therapy.
- ICU admission [ Time Frame: 28 days ]The requirement for ICU admission within 28 days from the start of experimental therapy.
- Mechanical ventilation [ Time Frame: 28 days ]The requirement for mechanical ventilation within 28 days from the start of experimental therapy.
- Mortality [ Time Frame: 28 days ]All cause mortality at 28 days from the start of experimental therapy.

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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 recent exposure to SARS-CoV-2 (such as repeated or extensive exposure to an infected individual(s) or cohabiting with a SARS-CoV-2 positive individual).
- Subjects must be 50 years or older if the exposure is due to cohabitation.
- Subjects must be free of clinical signs or symptoms of a potential COVID-19 diagnosis (Ordinal Scale of Clinical Improvement score of 0) with a SARS-CoV-2 infection symptom score (fever, cough, shortness of breath, and fatigue) of 0 in each category.
- Spirometry (forced expiratory volume in one second FEV1 and forced vital capacity [FVC]) ≥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.
- Ability to understand and give informed consent.
Exclusion Criteria:
- Previous infection with SARS-CoV-2.
- Receipt of any vaccine for the prevention of COVID-19 (single or multiple doses).
- A SARS-CoV-2 infection symptom score greater than 0 in any of the 4 catergories (fever, cough, shortness of breath or fatigue) at the time of screening (Ordinal Scale for Clinical Improvement score of 0).
- 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.
- Any condition which, in the opinion of the Principal Investigator, would prevent full participation

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): NCT04313023
United States, California | |
University of California Irvine | |
Orange, California, United States, 92868 | |
Premier 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 | |
Luminous Cinical Research- South Florida Urgent Care | |
Miami, Florida, United States, 33136 | |
Entrust Clinical Research | |
Miami, Florida, United States, 33156 | |
DBC Research | |
Tamarac, Florida, United States, 33321 | |
Affinity Clinical Research, LLC | |
Tampa, Florida, United States, 33612 | |
United States, Georgia | |
Clinical Research Atlanta | |
Stockbridge, Georgia, United States, 30281 | |
United States, Louisiana | |
Willis-Knighton Physcian Network | |
Bossier City, Louisiana, United States, 71111 | |
United States, Oklahoma | |
Ascension St John | |
Bartlesville, Oklahoma, United States, 74006 | |
Ascension St. John | |
Tulsa, Oklahoma, United States, 74104 | |
United States, Texas | |
Invesclinic US LLC | |
Edinburg, Texas, United States, 78539 | |
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: | NCT04313023 |
Other Study ID Numbers: |
PUL-042-501 |
First Posted: | March 18, 2020 Key Record Dates |
Last Update Posted: | September 2, 2021 |
Last Verified: | September 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 |