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

No results posted yet for this study

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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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 NCT04990830 on ClinicalTrials.gov