Status:
COMPLETED
The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
Lead Sponsor:
Pulmotect, Inc.
Collaborating Sponsors:
United States Department of Defense
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 followe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2021
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT04313023
Start Date
June 9 2020
End Date
July 31 2021
Last Update
May 17 2023
Active Locations (15)
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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