Dimolegin® (60 mg) for Patients With Moderate COVID-19: A Non-Interventional Study

Avexima Diol LLC

Status: Completed

Conditions: COVID-19

Treatments: Drug: Dimolegin

Study type: Observational

Funder types: Industry

Identifiers

NCT07134738

AVD-DIM-PM-2023-15

Details and patient eligibility

About

A multicenter, open-label, non-interventional study evaluates the safety and tolerability of oral Dimolegin® (60 mg once daily) for thromboprophylaxis in hospitalized adults (≥18 years) with moderate COVID-19 in real clinical pratice. The primary objective is to assess safety and tolerability of Dimolegin® in preventing thrombotic complications.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Here's a concise English translation:

• Voluntarily signed informed consent to participate in a non-interventional study.
• Hospitalized patients with moderate COVID-19 requiring anticoagulant therapy for prevention of thrombotic complications.
• Men and women aged ≥18 years.
• Patients prescribed Dimolegin® 10 mg enteric-coated film tablets for thromboprophylaxis as part of routine care for moderate COVID-19.
• Ability to understand study requirements, provide written consent and comply with protocol procedures.

Exclusion criteria

• Hypersensitivity to Dimolegin®.
• Clinically significant active bleeding at screening.
• Concomitant therapy with fibrinolytics or other anticoagulants.
• Anemia or thrombocytopenia.
• Thrombophilia.
• Other coagulopathies or contraindications to anticoagulants.
• Liver disease with impaired function or biliary tract disease.
• Creatinine clearance <30 mL/min.
• Gastrointestinal disorders affecting absorption.
• Pregnancy, breastfeeding, suspected pregnancy, or planned pregnancy within 3 months (including male patients whose partners plan pregnancy).
• Use of investigational or unapproved drugs, or participation in another clinical study within 90 days before therapy start.
• History or suspicion of alcohol or drug abuse, dependence, or addiction.
• Any other condition that, in the investigator's opinion, could interfere with study participation or pose undue risk.

Trial design

184 participants in 1 patient group

1 (Dimolegin® Group)

Description:

Dimolegin® is administered orally once dailyюThe recommended dose is 60 mg once daily. Treatment duration depends on clinical indication and may last up to 30 days.

Treatment:

Drug: Dimolegin