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

Conditions

• COVID-19

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Liquid Alpha1-Proteinase Inhibitor (Human) — BIOLOGICAL
  Intravenous infusion 120 mg/kg
• Placebo — DRUG
  Intravenous infusion
• Standard Medical Treatment — DRUG
  SMT

Study Details

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.

Key Dates

First listed

Sep 14, 2020

Start date

Jan 29, 2021

Status verified

Mar 2023

Primary completion

Dec 13, 2021

Completion

Jan 28, 2022

Study Design

Enrollment

57 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Liquid Alpha1-Proteinase Inhibitor + Standard Medical Treatment
  Participants received the first intravenous (IV) infusion of liquid alpha1-proteinase inhibitor (human) 120 milligrams per kilogram (mg/kg), based on body weight on Day 1, followed by second liquid alpha1-proteinase inhibitor (human) dose of 120 mg/kg based on body weight, on Day 8 (second dose was not mandatory and was given at the principal investigator's \[PI\] discretion). Participants also received all standard of care interventions while hospitalized, from Day 1 to Day 29.
• Placebo Comparator: Placebo + Standard Medical Treatment
  Participants received IV infusions of 0.9% normal saline of commensurate volume to that of liquid alpha1-proteinase inhibitor as placebo on Day 1 and Day 8 (Day 8 was not mandatory and was given at the PI's discretion). Participants also received all standard of care interventions while hospitalized, from Day 1 to Day 29.

Primary Outcome Measure

Percentage of Participants Dying or Requiring Intensive Care Unit (ICU) Admission [ Time Frame: Up to Day 29 ]

Locations (10)

Find similar trials in Birmingham, AL

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