Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Stage I: low dose group(400 µg/ time):N/A
Stage I: high dose group(960 µg/time):N/A
Stage II: low dose test group (400 µg/ time):Injection of ii-key-sars-cov-2 peptide vaccine
Stage II: low dose adjuvant control group:Injection of Croda aluminum adjuvant
Stage II: high dose trial arm (960µg/ time):Injection of ii-key-sars-cov-2 peptide vaccine
Stage II: high dose adjuvant control group:Injection of Croda aluminum adjuvant
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patient (or legal guardian) agrees to participate in the study and signs the informed consent form; 2. aged 18 to 65 years; 3. The nucleic acid test of severe acute respiratory syndrome coronavirus type 2 (sars-cov-2) was positive (results within 48 hours); 4. Light or normal type. The interval between the occurrence of symptoms and the visit <=5 days, and one or more of the following conditions exist at the same time: a. Patients with long-term positive sars-cov-2 nucleic acid test (e.g. continuous positive for more than 14 days). b. The immunoglobulin M (IgM) / immunoglobulin G (IgG) titer is low (less than 1:80) or negative after vaccination (including booster). c. Infected persons with at least one severe high-risk factor (including: Patients over 60 years old, with cardiovascular and cerebrovascular diseases (including hypertension), chronic lung diseases, diabetes, chronic liver diseases, kidney diseases, tumors and other underlying diseases, immune deficiency, etc.]
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Participating in other clinical studies of antiviral therapy; 3. Poor mental state, unable to cooperate, suffering from mental illness, lack of self-control, unable to express clearly; 4. The clinical symptoms of COVID-19 were classified as severe and critical; 5.The investigator thinks that it does not suit the requirements for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specific antibody titer;Neutralizing antibody titer;Time and rate of turning negative of sars-cov-2 virus;Length of stay of enrolled patients;Changes of viral load after treatment;Incidence of developing into heavy / dangerous;Immunogenicity assessment; | — |
Countries
China
Contacts
Public ContactLu Hongzhou
Shenzhen Third People's Hospital
Outcome results
None listed