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

NCT05185804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 399

Last updated 2022-01-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dimolegin

60 mg orally, 1 time per day

DRUG

Clexane

40 mg subcutaneously, 1 time per day

Sponsors & Collaborators

  • PharmaDiall Ltd.

    lead OTHER

Principal Investigators

  • Dmitry A Napalkov, Professor · Department of Faculty Therapy No. 1 of the Sechenov University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-08
Primary Completion
2021-08-06
Completion
2021-10-29

Countries

  • Russia

Study Locations

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Entities

Diseases

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 NCT05185804 on ClinicalTrials.gov