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

• Sponsor: Pulmotect, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04313023
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 217
• Locations: 15
• Arms: 2
• Actual Duration (Months): 13.7
• Patients Per Site: 14.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: PUL-042 Inhalation Solution; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• 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: Jun 9, 2020
• Actual Primary Completion Date: Jul 31, 2021
• Actual Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PUL-042 Inhalation Solution PUL-042 Inhalation Solution given by nebulization on Study Days 1, 3, 6, and 10	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	Drug: Placebo; Sterile saline for inhalation

Outcome Measures

Primary Outcome Measures

1. Severity of COVID-19 [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.

Secondary Outcome Measures

1. Incidence of SARS-CoV-2 infection [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

2. Incidence of SARS-CoV-2 infection [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

3. Severity of COVID-19 [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.

4. ICU admission [28 days]

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

5. Mechanical ventilation [28 days]

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

6. Mortality [28 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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).

2. Subjects must be 50 years or older if the exposure is due to cohabitation.

3. 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.

4. Spirometry (forced expiratory volume in one second FEV1 and forced vital capacity [FVC]) ≥70% of predicted value.

5. 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.

6. 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.

7. 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.

8. Ability to understand and give informed consent.

Exclusion Criteria:

1. Previous infection with SARS-CoV-2.

2. Receipt of any vaccine for the prevention of COVID-19 (single or multiple doses).

3. 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).

4. 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.

5. Any condition which, in the opinion of the Principal Investigator, would prevent full participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California Irvine	Orange	California	United States	92868
2	Premier Urgent Care of California	San Bernardino	California	United States	92404
3	Clinical Research of South Florida Alliance for Multispecialty Research	Coral Gables	Florida	United States	33134
4	Invesclinic US LLC	Fort Lauderdale	Florida	United States	33308
5	Luminous Cinical Research- South Florida Urgent Care	Miami	Florida	United States	33136
6	Entrust Clinical Research	Miami	Florida	United States	33156
7	DBC Research	Tamarac	Florida	United States	33321
8	Affinity Clinical Research, LLC	Tampa	Florida	United States	33612
9	Clinical Research Atlanta	Stockbridge	Georgia	United States	30281
10	Willis-Knighton Physcian Network	Bossier City	Louisiana	United States	71111
11	Ascension St John	Bartlesville	Oklahoma	United States	74006
12	Ascension St. John	Tulsa	Oklahoma	United States	74104
13	Invesclinic US LLC	Edinburg	Texas	United States	78539
14	MD Anderson Cancer Center	Houston	Texas	United States	77030
15	Next Level Urgent Care	Houston	Texas	United States	77057

Sponsors and Collaborators

• Pulmotect, Inc.
• United States Department of Defense

Investigators

• Study Director: Colin Broom, MD, Pulmotect, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pulmotect, Inc.
• ClinicalTrials.gov Identifier: NCT04313023
• Other Study ID Numbers: PUL-042-501
• First Posted: Mar 18, 2020
• Last Update Posted: Sep 2, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Pam2CSK4 acetate and ODN M362 combination

Study Results

No Results Posted as of Sep 2, 2021