COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04560881

Pedro Cahn, MD

pedro.cahn@huesped.org.ar

2020-09-23

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: - healthy subjects aged between 18 and 85 years old. - by asking for medical history and physical examination, the investigator judged that the health condition is well. - female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. effective contraceptive measures have been taken within 2 weeks before inclusion. - during the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan. - with self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

- active sars-cov-2 infection measured by rt-qpcr - has a history of sars, mers infection (self-report, on-site inquiry) - has clinical manifestation of fever (axillary temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination. - body temperature > 37.0 ℃ before vaccination - urine pregnancy test positive; - previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated sars-cov-2 vaccine have occurred. - has a history of convulsion, epilepsy, encephalopathy or mental illness or family history. - with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. - with severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure ≥ 140 mmhg, diastolic blood pressure ≥ 90 mmhg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases. - has been diagnosed with congenital or acquired immune deficiency, hiv infection, lymphoma, leukemia, or other autoimmune diseases. - with known or suspected diseases include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors. - has a history of coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disease) - receiving anti-tb therapy. - patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days) - inoculated live attenuated vaccines within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination. - received blood products within 3 months before this vaccination - received other research drugs within 6 months before this vaccination. - other circumstances judged by investigators that are not suitable for this clinical trial.

2

Laboratorio Elea Phoenix S.A.

18

85

Argentina

Healthy volunteers

N/A

3000

Incidence of COVID-19 cases after two-doses of vaccination

None

Phase 3

[{"arm_notes": "2;day0-21", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;day0-21", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]