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NCT04312997 · ClinicalTrials.gov registry record · Phase 2
The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection
A Phase 2 study, sponsored by Pulmotect.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT04312997: Completed Phase 2 study, sponsored by Pulmotect.
NCT04312997 is a Phase 2 study that has completed, run by Pulmotect. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04312997, a Phase 2 study, has completed, sponsored by Pulmotect.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study 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
Primary Outcome
To determine the efficacy of PUL-042 Inhalation Solution in decreasing the severity of COVID-19 in subjects: 1) who have documented SARS-CoV-2 infection, and 2) if receiving oxygen, should have pulse oximetry ≥ 93% on 3 liters per minute of oxygen or less delivered by nasal prongs (Ordinal Scale for Clinical Improvement 4 or less) at the time of enrollment. The primary endpoint analysis is the evaluation of the number of patients with clinically meaningful worsening of COVID-19 within 28 days f
Interventions
- DRUG Placebo
- DRUG PUL-042 Inhalation Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2020-06-16 |
| Est. Completion | 2021-07-02 |
| Phase | Phase 2 |
What the finished NCT04312997 record still lists
NCT04312997 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04312997 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04312997 about?
NCT04312997 is a clinical study titled "The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection". 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 se...
What is the current status of trial NCT04312997?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2020-06-16. Estimated completion is 2021-07-02.
What interventions are being tested in trial NCT04312997?
The interventions under investigation include: Placebo (DRUG), PUL-042 Inhalation Solution (DRUG).
Who is sponsoring clinical trial NCT04312997?
This trial is sponsored by Pulmotect, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04312997's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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