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Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Subjects With COVID-19

NCT04495101 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-08

No results posted yet for this study

Summary

The primary objective of the study is to determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with Coronavirus disease 2019 (COVID-19).

Conditions

Interventions

BIOLOGICAL

Prolastin

Intravenous infusion 120 mg/kg

DRUG

Standard Medical Treatment

Standard medical treatment per local policies or guidelines

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2021-04-26
Completion
2021-06-10

Countries

  • Spain

Study Locations

More Related Trials

Entities

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 NCT04495101 on ClinicalTrials.gov