COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04612972

German Malaga, MD

german.malaga@upch.pe

2020-11-03

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - age range: healthy subjects aged 18 years old and above - 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 do not plan to become pregnant within the first 3 months after enrolment . effective contraceptive measures have been taken within 2 weeks before inclusion and continued for at least three month s after last dose - 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 research procedures, with informed consent, voluntarily sign an informed consent form, and be able to comply with the requirements of the clinical study protocol.

- sars cov 2 infection confirmed cases, suspected cases or asymptomatic infection - sars cov 2 nucleic acid test positive - have a history of sars , mers infection (self report, on site inquiry - 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 - axillary body temperature > 37.0 ℃ before vaccination - 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. - have a history of convulsion, epilepsy, encephalopathy or mental illness or family history - congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. - 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 - diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors. - hist ory 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 - live attenuated va ccine is inoculated 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 vacc ination - investigator judged other circumstances that are not suitable for this clinical trial.

3

Universidad Peruana Cayetano Heredia

18

60

Peru

Healthy volunteers

N/A

12000

Proportion of confirmed Covid-19 cases in the two vaccine groups and the placebo group.

None

Phase 3

[{"arm_notes": "2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]