COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04656613

Mohamed Mostafa

Mohamed.Mostafa@pdc-cro.com

2020-12-07

Unknown

RCT

Randomized

Parallel

Blind label

unclear

Prevention

inclusion criteria: agree to sign the study informed consent form (icf) before performing any study-specific procedure. adults, i.e., ≥ 18 years old. negative hiv, hepatitis b, hepatitis c, and syphilis test results negative igm and igg sars cov2 antibodies enzyme immunoassay test result. negative covid-19 rt-pcr test result at the screening visit. no covid-19 in medical history. subjects to confirm they had no contact with covid-19 persons within at least 14 days before the screening visit. consent for using effective methods of contraception during the entire trial1 a negative urine pregnancy test at the screening visit (for child-bearing age women). negative alcohol test at the screening visit. 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 enrollment.

any vaccination/immunization within 30 days before the enrollment. history of covid-19. positive sars-cov-2 screening result obtained by pcr (at screening). test results for igm and igg antibodies to sars-cov-2 is positive. administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment. pregnancy or breast-feeding. acute coronary syndrome or stroke suffered less than one year before the enrollment. tuberculosis, chronic systemic infections in medical history. 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 vaccine components, acute exacerbation of allergic diseases on the enrollment day. known allergic reactions to vaccination history of asthma neoplasms in medical history. major operations in the past 12 months before study vaccine administration. this will include but not limited to; major organs transplant, bone marrow donation, etc. splenectomy in the past medical history neutropenia (absolute neutrophil count <1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/l), immunodeficiency in the medical history within 6 months before the enrollment. any family member with immunodeficiency, cancer, or transplantation the active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis b, or c. subjects with diabetes, heart disease, chronic kidney disease, or dialysis subjects with latent tuberculosis infection anorexia, protein deficiency of any origin. subjects with any metabolic diseases tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine/placebo administration. alcohol or drug addiction in medical history. participation in any other interventional clinical trial within the previous 90 days (from the administration of the vaccine). any other condition that the study physician considers as a barrier to the trial completion as per the protocol. healthcare workers

2

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

18

100

None

Healthy volunteers

N/A

1000

CD4+/CD8+ proliferating cells;SARS-CoV-2 glycoprotein-specific antibodies titer;Seroconversion rate;IFN-gamma antigen-specific release;Virus-neutralizing antibodies titer

None

Phase 3

[{"arm_notes": "1", "treatment_id": 532, "treatment_name": "Gam-covid-vac", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]