COVID-19
Conditions
Interventions
A8G6 experiment group:A8G6 SARS-CoV-2 Neutralizing Antibody Combination Nasal Spray
Blank control group:None
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Close contact population in Chongqing isolation point and control area: subjects aged 18-65 years (including critical value). 2. The subject is on the first day of isolation or preparing to enter the isolation phase 3. Subjects fully understand the purpose, nature, method and possible adverse reactions of the experiment, voluntarily participate in the experiment, and sign informed consent before the experiment begins; 4. Women of childbearing age had taken effective contraceptive measures within 2 weeks before joining the study, and the pregnancy test results were negative before enrollment. All subjects voluntarily agreed to use effective contraceptive methods from the signing of the informed consent to the end of the study period (effective contraceptive methods include: oral contraceptives (excluding emergency contraception), injected or embedded contraception, sustained release topical contraceptives, hormonal patches, intrauterine devices, sterilization, abstinence, condoms (male), diaphragm, cervical caps, etc.); 5. The subject agrees to only take nucleic acid samples from oropharyngeal swabs and not nasal swabs from the beginning of the study (-1 day) to the end of the study except for this study. 6. Those with negative nucleic acid test of SARS-CoV-2 during the screening period. 7. The subjects were able to communicate well with the researchers, and understood and complied with the requirements of the study. (All above requirements must be met to be included in the test)
Exclusion criteria
Exclusion criteria: 1. People with cognitive impairment or inability to understand Chinese; The participants who could not use Wechat to answer questions on mobile phones or for other reasons could not follow the scheme to complete the study or the researchers determined that it was not suitable for the participants. 2. Patients who are unable to understand or follow study procedures and sign written informed consent. 3. Allergic to any ingredients in this product and auxiliary materials; Or allergic (such as allergic to two or more drugs, food); 4. Previous history of SARS, SARS-CoV-2, MERS, or other human coronavirus infection or disease; 5. Patients who cannot tolerate intranasal administration before; 6. Used any nasal spray, nasal inhalation or other nasopharyngeal products within 2 months before screening, or could not stop using such products during the test period; 7. Patients who have received any nasopharyngeal surgery within 1 year, have acute episodes of chronic rhinitis in the past or have anatomical abnormalities in the nose that affect drug absorption; 8. Lactating or pregnant women; 9. Those who are participating in other COVID-19 related clinical trials, and who are or plan to participate in other clinical trials during the study period; 10. The investigator believes that the subject has any disease or condition that would place the subject at an unacceptable risk; The subject is unable to meet the protocol requirements; A condition that interferes with the assessment of response to a drug. (Compliance with any of the above item is not included in the test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy evaluation index: positive rate;Safety evaluation index: incidence of adverse reactions;Safety evaluation index: median occurrence time;Feasibility evaluation index: medication compliance;Feasibility evaluation index: Medication duration; | — |
Countries
China
Contacts
Public ContactZhang Dazhi, Mei Zhechuan
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed