drugset / Trial / NCT04990830

Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia

NCT04990830

Phase 2/3 Completed 80 enrolled Istanbul University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an investigator initiated, single-center, open-label, Phase IIb clinical trial with 40 patients (for a total of 80 patients) to assess efficacy of Low molecular weight heparin using soft mist inhaler in the treatment of critically ill patients with COVID-19 (coronavirus disease of 2019) induced ARDS (acute respiratory distress syndrome). The patients will be assigned in a 1:1 ratio to receive standard treatment protocol plus inhaled Low molecular weight heparin. The primary objective is to determine the hypoxemia improvement on a 5-point clinical scale for COVID-19 induced ARDS patients.

Timeline

Start
2021-02-03
Primary completion
2021-04-21
Completion
2021-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Enoxaparin sodium Other / unclassified 4000 iu Inhaled