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Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19)

NCT04547140 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-03-22

Study results available
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Summary

The purpose of the study is to determine if Liquid Alpha1-Proteinase Inhibitor (Human) (Liquid Alpha1-PI) plus SMT can reduce the proportion of participants dying or requiring intensive care unit (ICU) admission on or before Day 29 or who are dependent on high flow oxygen devices or invasive mechanical ventilation on Day 29 versus placebo plus SMT in hospitalized participants with COVID-19.

Conditions

Interventions

BIOLOGICAL

Liquid Alpha1-Proteinase Inhibitor (Human)

Intravenous infusion 120 mg/kg

DRUG

Placebo

Intravenous infusion

DRUG

Standard Medical Treatment

SMT

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-29
Primary Completion
2021-12-13
Completion
2022-01-28
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Chile
  • Colombia
  • Mexico

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 NCT04547140 on ClinicalTrials.gov