NCT05656495

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

An Open Randomized Multicenter Comparative Study to Evaluate the Efficacy, Safety and Tolerability of the Use of Ambervin® for Intramuscular Administration and for Inhalation in Patients Hospitalized With COVID-19

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Promomed, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Upon signing the informed consent form and screening, 313 eligible patients hospitalized with COVID-19 were randomized at a 1:1:1 ratio to receive either Ambervin intramuscular 1mg 1 times a day for 10 days or Ambervin inhaled 10mg 1 times a day for 10 days or SOC.

Conditions

• COVID-19

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-02-28
• Primary completion: 2022-11-22
• Completion: 2022-11-22
• First posted: 2022-12-19
• Last updated: 2023-04-06

Locations

10 sites across 1 country: Russia