NCT04313023

The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 217 (actual)
• Sponsor: Pulmotect, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	PUL-042 Inhalation Solution	20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution
DRUG	Placebo	Sterile saline for inhalation

Timeline

• Start date: 2020-06-09
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2020-03-18
• Last updated: 2023-05-17
• Results posted: 2023-05-17

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study