CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 101 enrolled
Drug / intervention
PUL-042 Inhalation Solution +1 moredrug
Likely dose
PUL-042 Inhalation Solution 20.3 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04312997
NCT04312997Phase 2Completed

A Phase 2 Multiple Dose Study to Evaluate the Efficacy and Safety of PUL-042 Inhalation Solution in Reducing the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

Pulmotect, Inc.·interventional·Posted Mar 18, 2020·Updated Apr 18, 2023

In Brief

A Phase 2 clinical trial evaluating PUL-042 Inhalation Solution and Placebo for COVID-19. Completed, enrolled 101 participants across 11 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 18, 2020
Enrollment StartJun 16, 2020
Primary CompletionJul 2, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 6.3 years ago

Interventions

PUL-042 Inhalation Solutiondrug

20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)

Placebodrug

Sterile saline for inhalation