Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 2

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

NCT04313023 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG PUL-042 Inhalation Solution

Study Locations (15)

Florida

  • Clinical Research of South Florida Alliance for Multispecialty Research — Coral Gables
  • Invesclinic US LLC — Fort Lauderdale
  • Luminous Cinical Research- South Florida Urgent Care — Miami
  • Entrust Clinical Research — Miami
  • DBC Research — Tamarac
  • Affinity Clinical Research, LLC — Tampa

Texas

  • Invesclinic US LLC — Edinburg
  • MD Anderson Cancer Center — Houston
  • Next Level Urgent Care — Houston

California

  • University of California Irvine — Orange
  • Premier Urgent Care of California — San Bernardino

Oklahoma

  • Ascension St John — Bartlesville
  • Ascension St. John — Tulsa

Georgia

  • Clinical Research Atlanta — Stockbridge

Louisiana

  • Willis-Knighton Physcian Network — Bossier City

Trial Details

FieldValue
Enrollment Target 217 participants
Start Date 2020-06-09
Est. Completion 2021-07-31
Phase Phase 2

Sponsor

Pulmotect

2 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04313023

The ClinicalTrials.gov registry entry for NCT04313023 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 217 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pulmotect, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04313023 reports 15 study locations spanning 6 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04313023 about?

NCT04313023 is a clinical study titled "The Use PUL-042 to Reduce the Infection Rate and Progression to COVID-19 in Adults Exposed to SARS-CoV-2". 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 wit...

What is the current status of trial NCT04313023?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 217 participants. The study started on 2020-06-09. Estimated completion is 2021-07-31.

What conditions does trial NCT04313023 study?

This clinical trial studies the following conditions: COVID-19. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04313023?

The interventions under investigation include: Placebo (DRUG), PUL-042 Inhalation Solution (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04313023?

This trial is sponsored by Pulmotect, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04313023 being conducted?

This trial has 15 study locations across California, Florida, Georgia, Louisiana, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial