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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04313023
Recruitment Status : Active, not recruiting
First Posted : March 18, 2020
Last Update Posted : July 16, 2021
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Pulmotect, Inc.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2021

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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. ICU admission [ Time Frame: 28 days ]
    The requirement for ICU admission within 28 days from the start of experimental therapy.

  5. Mechanical ventilation [ Time Frame: 28 days ]
    The requirement for mechanical ventilation within 28 days from the start of experimental therapy.

  6. Mortality [ Time Frame: 28 days ]
    All cause mortality at 28 days from the start of experimental therapy.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Pulmotect, Inc.
United States Department of Defense
Investigators
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Study Director: Colin Broom, MD Pulmotect, Inc.
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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: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Disease Progression
Disease Attributes
Pathologic Processes
PUL-042
Respiratory System Agents