Clinical Trial of Dimolegin (DD217) in Prevention of Thrombotic Complications in Patients With COVID-19
Status:
Completed
Trial end date:
2021-10-29
Target enrollment:
Participant gender:
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.