COVID-19
Conditions
Interventions
Healthy participants (group A):KFD1+3R-NC: 20µg+80µg
Healthy participants (group B):KFD1+3R-NC: 40µg+160µg
Participants recovered from SARS-CoV-2 infection (Group A):KFD1+3R-NC: 0µg+0µg
Participants recovered from SARS-CoV-2 infection (Group B):KFD1+3R-NC: 20µg +80µg
Participants recovered from SARS-CoV-2 infection (Group C):KFD1+3R-NC: 40µg +160µg
SARS-CoV-2 infection (Mild) (Treatment group):KFD1+3R-NC: 40µg +160µg
SARS-CoV-2 infection (Mild) (Control group):KFD1+3R-NC: 0µg +0µg
SARS-CoV-2 infection (Medium) (Treatment group):KFD1+3R-NC: 40µg +160µg
SARS-CoV-2 infection (Medium) (Control group):KFD1+3R-NC: 0µg +0µg
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: A. Age: 18-70 years old (may be appropriately widened to 80 years old), regardless of gender; B. Have been vaccinated with 2-3 doses of COVID-19 inactivated vaccine, and have been vaccinated with the last dose of vaccine for more than 6 months; C. Meet one of the following conditions: 1) Not infected with COVID-19; 2) Has been infected with COVID-19 once within 6 months (positive for antigen test or nucleic acid test) and has recovered; 3) Light or medium cases of COVID-19 infection were confirmed. According to the tenth edition of diagnostic criteria for novel coronavirus pneumonia, Mild: Upper respiratory tract infection is the main manifestation, such as dry throat, sore throat, cough, fever, etc. Medium: sustained high fever for more than 3 days or (and) coughing, shortness of breath, etc., but respiratory rate93% when inhaling air at rest. The imaging features of COVID-19 infection pneumonia can be seen. D. Understand the consent form and be willing to accept the above treatment;
Exclusion criteria
Exclusion criteria: A, Nasal deformity, trauma and other reasons lead to the inability to use nasal spray. B, During pregnancy and lactation C, History of severe allergies such as bronchial asthma, aspergillus infection, etc. D, Used inhalable vaccines E, Serious basic diseases such as tumor, organ transplantation, etc. F, Long-term use of immune agents, hormones and other drugs G, Do not cooperate with treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma SARS-CoV-2 IgG titer;Plasma neutralizing antibody titer;Salivary IgA concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of lymphocyte phenotype and function;SARS-CoV-2 load;Virus/antigen negative time;Reinfection rate;Duration and degree of clinical symptoms;Lung CT total lesion volume ratio; | — |
Countries
China
Contacts
Public ContactWu Qingguo
The Affiliated Public Health Clinical Center of Fudan University
Outcome results
None listed