drugset / Trial / NCT05656495

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

NCT05656495 ↗

Phase 3 Completed 313 enrolled Promomed, LLC
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Publications

  • Background L.A. Balykova, O.A. Radaeva, K.Ya. Zaslavskaya, P.A. Bely, V.F. Pavelkina, N.A. Pyataev, A.Yu. Ivanova, G.V. Rodoman, N.E. Kostina, V.B. Filimonov, E.N. Simakina, D.A. Bystritsky, A.S. Agafina, K.N. Koryanova, D.Yu. Pushkar. Efficacy and safety of original drug based on hexapeptide succinate in complex COVID-19 therapy in adults hospitalized patients. Pharmacy & Pharmacology. 2022;10(6):573-588. DOI: 10.19163/2307-9266-2022-10-6-573-588

Drugs

EvaluationDrugModalityDoseRoute
Subject Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate Unknown 1 mg Intramuscular
Subject Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate Unknown 10 mg Intramuscular

Indications