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Efficacy and Safety of Ambervin® and Standard Therapy in Hospitalized Patients With COVID-19

NCT05656495 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 313

Last updated 2023-04-06

No results posted yet for this study

Summary

This is open-labe randomized multicenter comparative Phase III study conducted in 8 medical facilities. The objective of the study is to assess the efficacy, safety and tolerability of Ambervin for intramuscular and inhaled administration in complex therapy COVID-19 compared with the Standard of care (SOC) in hospitalized patients with moderate COVID-19.

Conditions

Interventions

DRUG

Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularly

lyophilizate for preparation of solution for intramuscular administration 1 mg 1 time per day for 10 days

DRUG

Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaled

lyophilizate for preparation of solution for inhalation administration 10 mg 1 time per day for 10 days

DRUG

Standard of care

The administration of 'StandardTherapy' drugs was done according to the regimen recommended in the 'COVID-19TreatmentGuidelines'(current version)

Sponsors & Collaborators

  • Promomed, LLC

    lead OTHER

Principal Investigators

  • Dmitriy Pushkar · Moscow State Clinical Hospital №50

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2022-11-22
Completion
2022-11-22

Countries

  • Russia

Study Locations

More Related Trials

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 NCT05656495 on ClinicalTrials.gov