CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 217 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/NCT04313023
NCT04313023Phase 2Completed
CompareCT.gov

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

Pulmotect, Inc.·interventional·Posted Mar 18, 2020·Updated May 17, 2023

In Brief

A Phase 2 clinical trial evaluating PUL-042 Inhalation Solution and Placebo for COVID-19. Completed, enrolled 217 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited States
CollaboratorsUnited States Department of Defense

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 18, 2020
Enrollment StartJun 9, 2020
Primary CompletionJul 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 6.3 years ago

Interventions

PUL-042 Inhalation Solutiondrug

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

Placebodrug

Sterile saline for inhalation