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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

313 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-11-22

Brief Summary

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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.

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Detailed Description

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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

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ambervin intramuscularly

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Ambervin inhaled

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Standard of care

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

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Standard of care

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

Intervention Type DRUG

Other Intervention Names

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Ambervin intramuscularly Ambervin inhaled

Eligibility Criteria

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Inclusion Criteria

1. Availability of the Informed Consent Form of thePatient Information Leaflet (PIL) signed and dated bypatient.
2. Men and women aged 18 to 80 years inclusive at thetime of signing the Informed Consent Form in PIL.
3. 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.
4. Hospital admission due to COVID-19.
5. 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.
6. Lesion volume is minimal or moderate; CT 1-2.
7. 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

Exclusion Criteria

1. Hypersensitivity to components of the study drug.
2. Impossibility of CT procedure (for example, gypsumdressing or metal structures in the field of imaging).
3. Obstacles or inability to perform intramuscular injections and / or inhalations
4. 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.
5. The need for the use of drugs from the list of prohibited therapies.
6. Availability of criteria for severe and extremely severe disease at the time of screening
7. Presence within 6 months prior to screening of a probable or confirmed case of moderate COVID-19
8. History of presumptive or confirmed COVID-19 caseof moderate, severe and extremely severe course ofthe disease.
9. Vaccination less than 4 weeks prior to screening.
10. The need for treatment in the intensive care unit at the time of screening.
11. Impaired liver function (AST and/or ALT ≥ 2 UNLand/or total bilirubin ≥ 1.5 UNL) at the time ofscreening.
12. Renal impairment (GFR \< 60 ml/min) at the time of screening.
13. Positive testing for HIV, syphilis, hepatitis B and/or C.
14. Chronic heart failure FC III-IV according to New York Heart Association (NYHA) functional classification.
15. Malignancies in the past medical history.
16. Alcohol, pharmacological and/or drug addiction in the past medical history and/or at the time of screening.
17. Epilepsy in history.
18. Schizophrenia, schizoaffective disorder, bipolardisorder, or other history of mental pathology orsuspicion of their presence at the time of screening.
19. Severe, decompensated or unstable somatic diseases (any disease or condition that threaten thepatient's life or impair the patient's prognosis, and also make it impossible for him/her to participate in the clinical study).
20. Any history data that the investigating physician believes could lead to complication in the interpretation of the study results or create an additional risk to the patient as a result of his/her participation in the study.
21. Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of physician investigator).
22. Pregnant or nursing women or women planning pregnancy.
23. Participation in another clinical study for 3 monthsprior to inclusion in the study.
24. Other conditions that, according to the physicianinvestigator, prevent the patient from being includedin the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No