Clinical Trial of Dimolegin (DD217) in Prevention of Thrombotic Complications in Patients With COVID-19

Summary

Study purpose was to study the safety and efficacy of Dimolegin - DD217 as a drug for prevention of thrombotic complications compared to Clexane (enoxaparin sodium) - the standard therapy currently prescribed to patients hospitalized with COVID-19. Patients who met all inclusion criteria and no exclusion criteria were randomized into two therapy groups: * Group 1 - test drug Dimolegin - DD217 (60 mg orally, 1 time per day); * Group 2 - reference drug Clexane (40 mg subcutaneously, 1 time per day). The study drugs were taken once a day until: * the discharge from the hospital due to recovery or positive dynamics; * or up to 30 days of the patient's stay in the hospital; * or until the Investigator decides to discontinue the therapy for other reasons. Planned: screening of up to 450 patients, randomization: 430 (215 per group). The required number of patients is 200 per group as a result of the entire study.

Timeline

Start

2021-02-08

Primary completion

2021-08-06

Completion

2021-10-29

Publications

• Background Tovbin DG, Tarasov DN, Malakhov DV, Tserkovnikova NA, Aybush AV, Drozd NN. The Development of New Low-Molecular-Weight Factor Xa Inhibitors that are Potential Anticoagulants. Curr Drug Discov Technol. 2022;19(1):e010921191770. doi: 10.2174/1568009621666210224104940.
• Background Tarasov DN, Tovbin DG, Malakhov DV, Aybush AV, Tserkovnikova NA, Savelyeva MI, Sychev DA, Drozd NN, Savchenko AY. The Development of New Factor Xa Inhibitors Based on Amide Synthesis. Curr Drug Discov Technol. 2018;15(4):335-350. doi: 10.2174/1570163815666180215114732.

Drugs

Indications