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

NCT04389840 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-08-30

Study results available
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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.

Conditions

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

Interventions

DRUG

Dociparstat sodium

Dociparstat is a glycosaminoglycan derived from porcine heparin.

DRUG

Placebo

0.9% Normal Saline

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2021-05-20
Completion
2021-05-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT04389840 on ClinicalTrials.gov