NCT04389840

Dociparstat for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

A Phase 2/3 Study to Evaluate the Safety and Efficacy of Dociparstat Sodium for the Treatment of Severe COVID-19 in Adults at High Risk of Respiratory Failure

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of dociparstat sodium in adult patients with acute lung injury (ALI) due to Coronavirus Disease 2019 (COVID-19). This study was designed to determine if dociparstat sodium could accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

Detailed description

This was a randomized, double-blind, placebo-controlled, Phase 2/3 trial to evaluate the safety and efficacy of dociparsat sodium in adults patients with severe COVID-19 who were at high risk of respiratory failure. Eligible subjects were with confirmed COVID-19 and required hospitalization and supplemental oxygen therapy. This study was designed to determine if dociparstat sodium could accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.

Conditions

• Coronavirus Disease 2019 (COVID-19)
• Acute Lung Injury
• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

Interventions

Type	Name	Description
DRUG	Dociparstat sodium	Dociparstat is a glycosaminoglycan derived from porcine heparin.
DRUG	Placebo	0.9% Normal Saline

Timeline

• Start date: 2020-07-08
• Primary completion: 2021-05-20
• Completion: 2021-05-20
• First posted: 2020-05-15
• Last updated: 2022-08-30
• Results posted: 2022-08-30

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study