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

NCT04313023 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2023-05-17

Study results available
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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

Interventions

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

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
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-09
Primary Completion
2021-07-31
Completion
2021-07-31
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 NCT04313023 on ClinicalTrials.gov