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

Launched by PROMOMED, LLC · Dec 15, 2022

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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.

Trial Officials