Created at Source Raw Value Validated value
April 29, 2022, 10 p.m. oms

1. Aged <18 years and >65 years 2. Any vaccination/immunization within 30 days before the enrollment 3. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment 4. Any treatment with immunosuppressive therapy within 3 months before the enrollment 5. Any drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on enrollment day 6. Any neoplasms in the past medical history 7. Donated blood or plasma within 3 months before the enrollment 8. Any history or evidence of splenectomy 9. Any immunodeficiency state 10. Any history or evidence of anorexia or protein deficiency of any origin 11. Alcohol or drug addiction in the past medical history 12. Participation in any other interventional clinical trial within 3 months 13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol 14. Pregnancy or breast-feeding 15. Subjects who are tested positive for Coronavirus disease through RT-PCR SARS CoV-2 Test and positive anti-COVID antibodies within 3 months before the enrollment

1. Aged <18 years and >65 years 2. Any vaccination/immunization within 30 days before the enrollment 3. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment 4. Any treatment with immunosuppressive therapy within 3 months before the enrollment 5. Any drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on enrollment day 6. Any neoplasms in the past medical history 7. Donated blood or plasma within 3 months before the enrollment 8. Any history or evidence of splenectomy 9. Any immunodeficiency state 10. Any history or evidence of anorexia or protein deficiency of any origin 11. Alcohol or drug addiction in the past medical history 12. Participation in any other interventional clinical trial within 3 months 13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol 14. Pregnancy or breast-feeding 15. Subjects who are tested positive for Coronavirus disease through RT-PCR SARS CoV-2 Test and positive anti-COVID antibodies within 3 months before the enrollment