Effects of Low Molecular Weight Heparin Therapy With Soft-Mist Inhaler for COVID-19 Induced Hypoxemia
NCT04990830 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2021-08-05
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.
Conditions
- COVID-19 Acute Respiratory Distress Syndrome
- Hypoxemia
Interventions
- DRUG
-
Inhaled Low molecular weight heparin
Application with Soft Mist Inhaler
- DRUG
-
Standard Treatment
Control Group
Sponsors & Collaborators
-
Istanbul University
lead OTHER
Principal Investigators
-
Ayca Yildiz-Pekoz, PhD · Istanbul University Faculty of Pharmacy
-
Mustafa Erelel, MD · Istanbul University Faculty of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-03
- Primary Completion
- 2021-04-21
- Completion
- 2021-05-21
Countries
- Turkey (Türkiye)
Study Locations
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