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The Use of PUL-042 Inhalation Solution to Reduce the Severity of COVID-19 in Adults Positive for SARS-CoV-2 Infection

NCT04312997 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-04-18

Study results available
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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

Interventions

DRUG

PUL-042 Inhalation Solution

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

DRUG

Placebo

Sterile saline for inhalation

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Pulmotect, Inc.

    lead INDUSTRY

Principal Investigators

  • Colin Broom, MD · Pulmotect, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-16
Primary Completion
2021-07-02
Completion
2021-07-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04312997 on ClinicalTrials.gov