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NCT04313023 · ClinicalTrials.gov registry record · Phase 2
The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2
A Phase 2 study of COVID-19, sponsored by Pulmotect.
- Completed
- Registry status
- Phase 2
- Development phase
- 217
- Enrollment target
- 15
- Study locations
NCT04313023: Completed Phase 2 study of COVID-19, sponsored by Pulmotect.
NCT04313023 is a Phase 2 study of COVID-19 that has completed, run by Pulmotect. The registered enrollment target is 217 participants, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower). The trial reports 15 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04313023, a Phase 2 study of COVID-19, has completed, sponsored by Pulmotect.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 217 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
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 (OSCI) within 28 days from the start of experimental therapy. The OSCI to be use
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PUL-042 Inhalation Solution
Study Locations (15)
Florida
- Clinical Research of South Florida Alliance for Multispecialty Research - Coral Gables
- Invesclinic US LLC - Fort Lauderdale
- Luminous Cinical Research- South Florida Urgent Care - Miami
- Entrust Clinical Research - Miami
- DBC Research - Tamarac
- Affinity Clinical Research, LLC - Tampa
Texas
- Invesclinic US LLC - Edinburg
- MD Anderson Cancer Center - Houston
- Next Level Urgent Care - Houston
California
- University of California Irvine - Orange
- Premier Urgent Care of California - San Bernardino
Oklahoma
- Ascension St John - Bartlesville
- Ascension St. John - Tulsa
Georgia
- Clinical Research Atlanta - Stockbridge
Louisiana
- Willis-Knighton Physcian Network - Bossier City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2020-06-09 |
| Est. Completion | 2021-07-31 |
| Phase | Phase 2 |
What the finished NCT04313023 record still lists
NCT04313023 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 38,464-participant average among 298 other COVID-19 trials with a reported enrollment target (99% lower).
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04313023 lists 15 locations in 6 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT04313023 about?
NCT04313023 is a clinical study titled "The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2". 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 wit...
What is the current status of trial NCT04313023?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2020-06-09. Estimated completion is 2021-07-31.
What conditions does trial NCT04313023 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT04313023?
The interventions under investigation include: Placebo (DRUG), PUL-042 Inhalation Solution (DRUG).
Who is sponsoring clinical trial NCT04313023?
This trial is sponsored by Pulmotect, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04313023 being conducted?
This trial has 15 study locations across California, Florida, Georgia, Louisiana, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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217 158th of 298 higher than 141 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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