COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05293223

Pedro Cahn

Not reported

2022-03-24

Not recruiting

nonRCT

Non-randomized

Parallel

Open label

multi-center

Prevention

inclusion criteria: participants aged 18 years and above at the time of randomization. provide written informed consent. axillary temperature ≤ 37℃. never received any investigational or licensed covid-19 vaccine other than the 1st dose of sputnik v with an interval of 21-90 days before the study. subjects are eligible for immunization of this product as evaluated by investigators after medical history examination, physical examination and clinical judgment of health.

have a history of seizures, epilepsy, encephalopathy, psychosis. history of anaphylaxis to any vaccine component. positive urine pregnancy test result, pregnant, lactation women, or intend to become pregnant within the next 6 months. congenital or acquired angioedema/neuroedema. medical history of guillain-barré syndrome. asplenia or functional absence of spleen. bleeding disorder (e.g. protein s or factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following im injections or venipuncture. any confirmed or suspected immunosuppressive or immunodeficient state; received immunosuppressive therapy, cytotoxic therapy, or chronic corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis) within the past 6 months, history of chronic systematic infection. administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate. receiving anti-tuberculosis or cancer treatment. history of laboratory-confirmed covid-19, or has a positive result at the examination of sars-cov-2 antigen before vaccination. planned to receive any vaccine (licensed or investigational), other than the study intervention, within 14 days before and after study vaccination. continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban). any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

2

Fundación Huésped

18

100

Argentina

Healthy volunteers

N/A

450

The Geometric mean titers (GMTs) of SARS-CoV-2 neutralizing antibody

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 26, "treatment_name": "Ad5-ncov", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]