Phase 2
N=101
The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04312997 ↗Enrolled (actual)
101
Serious AEs
3.0%
Results posted
Apr 2023
Primary outcome: Primary: Number of Participants With Worsening of COVID-19 Within 28 Days — 1; 1 Participants
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 Number of Participants With Worsening of COVID-19 Within 28 Days |
1; 1 | — |
| SECONDARY Number of Participants With Positive SARS-CoV-2 Test Results at the End of Study |
8; 9 | — |
| SECONDARY Number of Participants With Worsening of COVID-19 Over 14 Days |
1; 1 | — |
| SECONDARY Time to COVID-19 Symptom Improvement: Respiratory Symptoms |
6; 9 | — |
| SECONDARY Time to Resolution of COVID-19 Symptoms |
11; 11 | — |
| SECONDARY Number of Participants Requiring ICU Admission |
0; 2 | — |
| SECONDARY Number of Participants Requiring Mechanical Ventilation |
0; 0 | — |
| SECONDARY Number of Participant Death |
0; 0 | — |
Summary
Adults who have tested positive for SARS-CoV-2 infection and who may require supplemental oxygen will receive PUL-042 Inhalation Solution or placebo 3 times over a one week period in addition to their normal care. Subjects will be be followed and assessed for their clinical status over 28 days to see if PUL-042 Inhalation Solution improves the clinical outcome
Eligibility Criteria
Inclusion Criteria
- Subjects must have a positive test for SARS-CoV-2.
- COVID-19 signs and symptoms such as (fever, cough, shortness of breath or fatigue) with onset within the 7 days prior to Screening
- Subjects should be Ordinal Scale for Clinical Improvement score of 4 or less.
- Subjects receiving oxygen should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs.
- Subjects can be receiving standard of care (SOC) for COVID-19, this includes marketed therapies or therapies with Emergency Use Authorization (EUA) for COVID-19 treatment.
- Subject's spirometry (FEV1 and forced vital capacity [FVC]) must be ≥70% of predicted value.
- If female, the subject must be surgically sterile or ≥ 1 year postmenopausal. If of child-bearing potential (including being 4) or with pulse oximetry less than 93% on oxygen with a flow rate of 3 liters per minute or less by nasal prongs at the time of screening.
- 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.
- Exposure to any investigational therapy (defined as any agent not currently marketed or without EUA) at the time of or within 30 days prior to the Screening Visit.
- Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of trial endpoints
Data sourced from ClinicalTrials.gov (NCT04312997). 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.