COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04564716

Roman Plotnikov

rplot@ipharma.ru

2020-09-25

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - the subject's written informed consent to participate in the study; - male and female subjects between the ages of 18 and 60 years (inclusive). - a negative test result for hiv, hepatitis, syphilis; - negative result of research on antibodies igm and igg to sars cov2 by enzyme-linked immunosorbent assay; - a negative result of the covid-2019 study, as determined by the pcr method at the screening visit; - lack of covid-2019 in anamnesis; - lack of contact of the subject with covid-2019 patients for at least 14 days before inclusion in the study (according to the participant); - agreement to use effective contraceptive methods throughout the study period; - negative pregnancy test based on the results of a urine test at a screening visit (for women of childbearing age); - a negative test for the presence of narcotic substances and psycho-stimulating drugs in the urine at the screening visit; - negative alcohol test at the screening visit; - lack of pre-existing post-vaccination reactions or post-vaccination complications following the use of immunobiological drugs; - no acute infectious and/or respiratory diseases for at least 14 days before inclusion in the study.

- any vaccination/immunization carried out within 30 days prior to enrollment in the study; - treatment with steroids (except hormonal contraceptives) and/or with immunoglobulins or other blood products not completed 30 days before inclusion in the study; - immunosuppressive therapy completed less than three months before inclusion in the study; - female subjects during pregnancy or breastfeeding; - acute coronary syndrome or stroke suffered less than one year before inclusion into the study; - tuberculosis, chronic systemic infections; - aggravated allergy anamnesis (anamnesis of anaphylactic shock, quinque edema, polymorphic exudative eczema, atopia, serum disease), hypersensitivity or allergic reactions to immunobiological drugs, known allergic reactions to the components of the drug, aggravation of allergic diseases on the day of inclusion in the study; - the presence of neoplasms in the anamnesis (codes c00-d09); - donated blood or plasma (450 ml or more) less than 2 months before inclusion in the study; - splenectomy in anamnesis; - neutropenia (decrease in absolute number of neutrophils less than 1000/mm3), agraneulocytosis, significant haemorrhage, severe anaemia (hemoglobin less than 80 g/l), immunodeficiency in anamnesis for 6 months before inclusion in the study; - subjects with an active form of disease caused by human immunodeficiency virus, syphilis, hepatitis b and c; - anorexia, protein deficiency of any origin; - chronic autoimmune diseases or systemic collagenoses in anamnesis - extensive tattoos at the injection site (deltoid region) that do not allow for an assessment of the local response to imp/placebo administration; - alcoholism and drug addiction in anamnesis; - participation of the subject in any other interventional clinical trial; - any other condition of the subject which, in the opinion of the researcher's medical practitioner, may prevent completion of the investigation according to the protocol; - staff of research centers and other staff directly involved in the study and their families.

2

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

18

60

Belarus

Healthy volunteers

N/A

100

percentage of trial subjects with coronavirus disease 2019 (COVID-19) developed within 6 months after the first dose

None

Phase 3

[{"arm_notes": "2;day1-21", "treatment_id": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;day1-21", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]