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

NCT05656495 | Completed Phase 3

• 1 other identifier: AMB-112021
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 10

Brief 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

COVID-19

Keywords

SARS-CoV-2; Ambervin

Outcome Measures

Primary Outcomes (1)

• Prevalence of patients with category 0-1 as per categorical ordinal clinical improvement WHO scale

  The proportion of patients with category 0-1 as per the categorical ordinal clinical improvement scale

  From baseline to Visit 4 (days 14-15)

Secondary Outcomes (13)

• Prevalence of patients with clinical status less than 4 points on the categorical ordinal WHO scale of clinical improvement

  From baseline to Visit 3 (days 11-12) and 4 (days 14-15)

• Frequency of improvement in clinical status on a categorical ordinal WHO scale of clinical improvement of 2 or more categories

  From baseline to Visit 3 (days 11-12) and 4 (days 14-15)

• Time to improve clinical status on a categorical ordinal scale of clinical improvement by ≥ 1 point.

  From baseline to Visit 6 (study completion, day 28±1)

• Prevalence of patients eligible for discharge to continue outpatient treatment according to BMR

  From baseline to Visit 2 (days 6-7), 3 (days 11-12)

• Prevalence of patients with RR < 22/min

  From baseline to Visit 2 (days 6-7), 3 (days 11-12)

Study Arms (3)

Ambervin intramuscularly

EXPERIMENTAL

Arm 1 (n=104) receives the study drug Ambervin for intramuscularly administration 1 mg 1 time per day. The course of treatment is 10 days.

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

Ambervin inhaled

EXPERIMENTAL

Arm 2 (n=105) receives the study drug Ambervin for inhalation administration 10 mg 1 time per day. The course of treatment is 10 days.

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

Standard of care

ACTIVE COMPARATOR

Arm 3 (n=104) patients receive standard therapy prescribed in accordance with the recommended treatment regimens included in the InterimGuidelines for the prevention, diagnosis and treatment of new coronavirus infection (COVID-19) approved by the Russian Ministry of Health by decision of the investigator and taking into account the availability of drugs at the study site

Drug: Standard of care

Interventions

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

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

Also known as: Ambervin intramuscularly

Ambervin intramuscularly

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

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

Also known as: Ambervin inhaled

Ambervin inhaled

Standard of care DRUG

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

Standard of care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Availability of the Informed Consent Form of thePatient Information Leaflet (PIL) signed and dated bypatient.
• Men and women aged 18 to 80 years inclusive at thetime of signing the Informed Consent Form in PIL.
• Confirmed case of COVID-19 at the time ofscreening based on SARS-CoV-2 RNA test usingnucleic acid amplification (NAA) method. It isacceptable to include a patient with a presumptiveCOVID-19 diagnosis prior to receiving the results ofSARS-CoV-2 RNA test made at the screening stage.
• Hospital admission due to COVID-19.
• Moderate severity infection with SARS-CoV-2: Clinical signs (the presence of at least 2 of the following criteria):
• body temperature \> 38 °C;
• RR \> 22/min;
• CT pattern typical of a viral lesion
• shortness of breath on exertion;
• SpO2 \< 95%;
• Serum CRP \> 10 mg/L.
• Lesion volume is minimal or moderate; CT 1-2.
• Patient's consent to use reliable contraceptive methods through out the study and within 1 month for women and 3 months for men after its completion. Reliable means of contraception are: sexualabstinence, use of condom in combination withspermicide.
• Women incapable of childbearing may also participate inthe study (with past history of: hysterectomy, tubal ligation,infertility, menopause for more than 2 years), as well asmen with infertility or a history of vasectomy

You may not qualify if:

• Hypersensitivity to components of the study drug.
• Impossibility of CT procedure (for example, gypsumdressing or metal structures in the field of imaging).
• Obstacles or inability to perform intramuscular injections and / or inhalations
• Arterial hypotension (a decrease in blood pressure (BP) below 100/60 mm Hg) at the time of screening and / or a history of hypotensive crises.
• The need for the use of drugs from the list of prohibited therapies.
• Availability of criteria for severe and extremely severe disease at the time of screening
• Presence within 6 months prior to screening of a probable or confirmed case of moderate COVID-19
• History of presumptive or confirmed COVID-19 caseof moderate, severe and extremely severe course ofthe disease.
• Vaccination less than 4 weeks prior to screening.
• The need for treatment in the intensive care unit at the time of screening.
• Impaired liver function (AST and/or ALT ≥ 2 UNLand/or total bilirubin ≥ 1.5 UNL) at the time ofscreening.
• Renal impairment (GFR \< 60 ml/min) at the time of screening.
• Positive testing for HIV, syphilis, hepatitis B and/or C.
• Chronic heart failure FC III-IV according to New York Heart Association (NYHA) functional classification.
• Malignancies in the past medical history.

Sponsors & Collaborators

• Promomed, LLC: lead

Study Sites (10)

Budgetary institution of the Chuvash Republic "Emergency Hospital"

Cheboksary, Russia

Location

City clinical Hospital №24

Moscow, Russia

Location

Infectious Clinical Hospital No.1

Moscow, Russia

Location

State Budgetary Healthcare Institution City Clinical Hospital named after S. I. Spasokukotskiy of Moscow Healthcare Department

Moscow, Russia

Location

Regional Clinical Hospital

Ryazan, Russia

Location

Ryazan State Medical University named after academician I.P. Pavlov of Ministry of Health of the Russian Federation

Ryazan, Russia

Location

Ogarev Mordova State University of Ministry of Health of the Russian Federation

Saransk, Russia

Location

City Hospital No. 40 Kurortny District

Sestroretsk, Russia

Location

Regional State Budget Healthcare Institution "Clinical hospital No. 1"

Smolensk, Russia

Location

Voronezh Regional Clinical Hospital No.1

Voronezh, Russia

Location

Related Publications (1)

• 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

  BACKGROUND

Related Links

• Cyberleninka is an open access scientific electronic library

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Dmitriy Pushkar

  Moscow State Clinical Hospital №50

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 19, 2022
• Study Start: February 28, 2022
• Primary Completion: November 22, 2022
• Study Completion: November 22, 2022
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (10)