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COVID-19Phase 3NCT05656495

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

A Phase 3 study testing Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularly and Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaled in people with COVID-19, run by Promomed, LLC at 10 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
COVID-19
What is being tested?
Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularly and Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaled
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
313 participants
Where
10 sitesRussia
Study dates
28 Feb 2022to 22 Nov 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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

Who cannot join

  • 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
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  • 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.
  • Alcohol, pharmacological and/or drug addiction in the past medical history and/or at the time of screening.
  • Epilepsy in history.
  • Schizophrenia, schizoaffective disorder, bipolardisorder, or other history of mental pathology orsuspicion of their presence at the time of screening.
  • 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).
  • 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.
  • Patient's unwillingness or inability to comply with procedures of the Study Protocol (in the opinion of physician investigator).
  • Pregnant or nursing women or women planning pregnancy.
  • Participation in another clinical study for 3 monthsprior to inclusion in the study.
  • Other conditions that, according to the physicianinvestigator, prevent the patient from being includedin the study.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Russia10 sites

  • Budgetary institution of the Chuvash Republic "Emergency Hospital"

    Cheboksary

  • City clinical Hospital №24

    Moscow

  • Infectious Clinical Hospital No.1

    Moscow

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

    Moscow

  • Regional Clinical Hospital

    Ryazan

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

    Ryazan

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

    Saransk

  • City Hospital No. 40 Kurortny District

    Sestroretsk

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

    Smolensk

  • Voronezh Regional Clinical Hospital No.1

    Voronezh

Other trials in Russia

About this study

Official title: 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

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.

Read the 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
Being tested
Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularly, Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaled, Standard of care
Keywords
SARS-CoV-2, Ambervin
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularlyDrug

    Also called Ambervin intramuscularly

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

  • Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaledDrug

    Also called Ambervin inhaled

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

  • Standard of careDrug

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

Study groups in NCT05656495
Study groupRoleWhat they receive
Ambervin intramuscularlyExperimentalArm 1 (n=104) receives the study drug Ambervin for intramuscularly administration 1 mg 1 time per day. The course of treatment is 10 days.
Receives: Drug: Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularly
Ambervin inhaledExperimentalArm 2 (n=105) receives the study drug Ambervin for inhalation administration 10 mg 1 time per day. The course of treatment is 10 days.
Receives: Drug: Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaled
Standard of careActive comparatorArm 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
Receives: Drug: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From baseline to Visit 4 (days 14-15)

Secondary outcomes (13)

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

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

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

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

    The proportion of patients with clinical status on a categorical ordinal WHO scale of clinical improvement of 2 or more categories

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

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

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

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

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

    The proportion of patients eligible for discharge to continue outpatient treatment according to current Cuidelines

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

  5. Prevalence of patients with RR < 22/min

    The proportion of patients with RR < 22/min

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

  6. Prevalence of patients with CRP level < 10 mg/l

    The proportion of patients with CRP level < 10 mg/l

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

  7. Prevalence of patients with blood lymphocytes > 1.2 x 10(9)/L

    The proportion of patients with blood lymphocytes > 1.2 x 10(9)/L

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

  8. Assessment of the degree of lung damage according to CT

    The degree of lung damage according to CT

    Measured: From baseline to Visit 4 (days 14-15)

  9. Prevalence of patients with SpO2 ≥ 95% on 2 consecutive days

    The proportion of patients with SpO2 ≥ 95% on 2 consecutive days

    Measured: From baseline to Visit 2 (days 6-7), 3 (days 11-12), 4 (days 14-15)

  10. The frequency of transfer of patients to the intensive care unit and intensive care

    The proportion of patients transferred to the intensive care unit and intensive care

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

  11. The frequency of cases of the use of high flow oxygen therapy, non-invasive and invasive ventilation of lung, ECMO

    The proportion of patients who used high flow oxygen therapy, non-invasive and invasive ventilation of lung, ECMO

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

  12. The frequency of cases of ARDS

    The proportion of patients with ARDS

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

  13. The frequency of patients with a fatal outcome

    The proportion of patients with a fatal outcome

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2022
  2. Study start28 Feb 2022
  3. Primary completion22 Nov 2022
  4. Study completion22 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
313 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05656495
Sponsor's protocol ID
AMB-112021
Status last verified
Apr 2023
First submitted
15 Dec 2022
Last updated
6 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate intramuscularly and Tyrosyl-D-alanyl-glycyl-phenylalanyl-leucyl-arginine succinate inhaled in people with COVID-19, run by Promomed, LLC at 10 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of patients with category 0-1 as per categorical ordinal clinical improvement WHO scale (time frame: From baseline to Visit 4 (days 14-15)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05656495, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.

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