PharmaDiall LLC

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.

This study is a multicenter, double-blind, randomized, prospective phase 2 dose ranging study to evaluate the safety and efficacy of Dimolegin - DD217 in prevention of venous thromboembolic complications in patients underwent knee replacement.
The study model is at each stage in parallel groups. Dimolegin - DD217 efficacy and safety in prevention of venous thromboembolic complications during knee replacement in groups of 80 patients will be investigated.
Patients who meet all inclusion criteria and none of the exclusion criteria will be randomized into three therapy groups: two therapy groups of the test drug Dimolegin - DD217 (40 mg (group 1a) and 60 mg (group 1b)) and one reference group (Fragmin).
Bilateral phlebography (preferably) or ultrasound duplex scanning (USDS) will be performed on the Day of the V13 visit.
It is planned to randomize 240 patients (160 patients in two different groups of Dimolegin - DD217 therapy and 80 patients in the reference group of Fragmin (INN: dalteparin).
The number of patients included in the study and randomized to receive Dimolegin - DD217, at the first stage, can be increased in the case of starting recruitment to additional group 1b.
The maximum number of patients who can be included in the study at the first stage is 320.
In total, no more than 480 patients can take part in the screening. Pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be determined in patients who voluntarily give their consent to participate in the pharmacokinetic study (PKS) and pharmacodynamic study (PDS) and sign a Patient Information Leaflet with an informed consent form for participation in the PKS and PDS.
PK parameters are planned to be determined in 18-20 patients (50 % of each sex) in each patient group. Participation in the voluntary part of PK study will be offered to all patients.
The analysis of the composite endpoint frequency will be carried out using a generalized linear model for binary response.
A formal conclusion about superiority will be made if the lower limit of the specified confidence intervals exceeds the value of 0.0.
A formal conclusion on non-inferiority will be made if the lower limit of the specified confidence intervals exceeds the value of -0.05 (-5.0 %).

In the course of the clinical study, the pharmacokinetics, pharmacodynamics, safety and tolerability of Dimolegin (DD217) 10 mg enteric-coated tablets after single administration to healthy volunteers at increasing doses were studied.
24 volunteers participated in the study. The randomization procedure was carried out for 24 volunteers selected at screening. In Group 1 6 volunteers were randomized , in Group 2 6 volunteers were randomized, and in Group 3 12 volunteers were enrolled. Group 1 volunteers took the study drug at a dose of 20 mg once, group 2 volunteers took the study drug at a dose of 40 mg once, and group 3 volunteers took the study drug at a dose of 60 mg once.