COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04352608

Fengcai Zhu

jszfc@vip.sina.com

2020-04-20

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - healthy adults aged 18-59 years; - proven legal identity; - participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;

- travel history / residence history of wuhan city and surrounding areas, or other communities with case reports within 14 days; - history of contact with a sars-cov-2 infection (positive in nucleic acid test) within 14 days; - have contacted patients with fever or respiratory symptoms from wuhan and surrounding areas, or from communities with case reports within 14 days; - have contacted patients with fever or respiratory symptoms from wuhan and surrounding areas, or from communities with case reports within 14 days; - self-reported history of sars; - self-reported history of new coronavirus infection; - positive in serum antibodies (igg or igm) screening of covid-19; - positive in nasopharyngeal swabs or anal swabs through rt-pcr; - women who are breastfeeding, pregnant or planning to become pregnant during the study period; - bmi≥35 kg/m2; - history of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema; - congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; - autoimmune disease or immunodeficiency / immunosuppression; - suffering from severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.; - severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; - thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition; - diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; - immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months; - abnormal laboratory test results in the physical examination such as clinically significant abnormal hematology and biochemistry beyond the reference value range (only applicable to phase i clinical trials); - history of alcohol or drug abuse; - receipt of blood products within in the past 3 months; - receipt of other investigational drugs in the past 30 days; - receipt of attenuated live vaccines in the past 14 days; - receipt of inactivated or subunit vaccines in the past 7 days; - attacks of acute diseases or chronic diseases in the past 7 days; - axillary temperature >37.0°c; - according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

6

Sinovac Research and Development Co., Ltd.

18

59

China

Healthy volunteers

N/A

744

Immunogenicity indexes of neutralizing-antibody seroconversion rates;Safety indexes of adverse reactions

None

Phase 1/Phase 2

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