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TD-0903 for ALI Associated With COVID-19

NCT04402866 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2022-03-17

Study results available
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Summary

This Phase 2 study will evaluate the efficacy, safety, pharmacodynamics and pharmacokinetics of inhaled TD-0903 compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with confirmed COVID-19 associated acute lung injury and impaired oxygenation.

Conditions

  • Acute Lung Injury (ALI) Associated With COVID-19
  • Lung Inflammation Associated With COVID-19

Interventions

DRUG

TD-0903

Study Drug to be administered by inhalation

DRUG

Placebo

Placebo to be administered by inhalation

Sponsors & Collaborators

  • Theravance Biopharma

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2021-04-21
Completion
2021-04-21
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Finland
  • Moldova
  • Romania
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT04402866 on ClinicalTrials.gov