COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04741061

Elena Merkulova

eam@ipharma.ru

2021-02-05

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: agree to sign the study informed consent form (icf) before performing any study specific procedure adults ≥ 18 years old negative covid-19 pcr test result at the screening visit and negative immunochromatographic sars-cov-2 antigen rapid-test result at the enrolment consent for using effective methods of contraception during the study no evidence of vaccine-induced reactions or complications after receiving immunobiological products in medical history no acute infectious and/or respiratory diseases within at least 14 days before the enrolment

any previous vaccination/immunization (within 30 days before the enrollment) and any planned vaccination within 30 days after enrollment any previous or planning covid-19 vaccination with any other regulatory approved vaccine positive sars-cov-2 screening result obtained by pcr (at screening) administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment pregnancy or lactation acute coronary syndrome or stroke suffered less than one year before study enrollment tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history history of severe allergic reaction to drug or vaccine (anaphylactic shock, quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day chronic autoimmune disease and system collagenases in medical history organ transplantation and immunosuppressive therapy immunosuppressive therapy and corticosteroid system therapy within 3 months before the enrollment subjects with malignant neoplasms within 5 years before the enrollment splenectomy in the past medical history neutropenia (absolute neutrophil count <1,000 mm3 agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficient disease in the medical history within 6 months before the enrollment the active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b, or c acute kidney injury or dialysis anorexia or dysnutrition tattoos at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the vaccine/placebo alcohol or drug abuse in medical history participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial any other condition that the investigator considers as a barrier to the trial completion as per the protocol

2

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

18

111

Russia

Healthy volunteers

N/A

6000

Incidence and severity of adverse events in study subjects;Percentage of study subjects with COVID-19 cases developed after vaccination

None

Phase 3

[{"arm_notes": "", "treatment_id": 1231, "treatment_name": "Sputnik light vaccine", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]