NCT04312997

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 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Pulmotect, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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)
DRUG	Placebo	Sterile saline for inhalation

Timeline

• Start date: 2020-06-16
• Primary completion: 2021-07-02
• Completion: 2021-07-02
• First posted: 2020-03-18
• Last updated: 2023-04-18
• Results posted: 2023-04-18

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study