Phase 2
N=217
The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04313023 ↗Enrolled (actual)
217
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 28 Days From the Start of Experimental Therapy. — 0.028; 0.048 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PUL-042 Inhalation Solution (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pulmotect, Inc.
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 28 Days From the Start of Experimental Therapy. |
0.028; 0.048 | — |
| SECONDARY Percentage of SARS-CoV-2 Infections Through Day 29 |
3.37; 3.23 | — |
| SECONDARY Percentage of SARS-CoV-2 Infections Through Day 15 |
2.17; 2.13 | — |
| SECONDARY Severity of COVID-19: Evaluation of the Severity of COVID-19 as Measured by the Maximum Difference From the Baseline Value in the OSCI Within 14 Days From the Start of Experimental Therapy. |
0.018; 0.048 | — |
| SECONDARY Number of Participants With ICU Admission |
0; 0 | — |
| SECONDARY Number of Participants Requiring Mechanical Ventilation |
0; 0 | — |
| SECONDARY Number of Participant Deaths |
0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04313023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.