drugset / Trial / NCT05656495
Efficacy and Safety of Ambervin® and Standard Therapy in Hospitalized Patients With COVID-19
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |