Coronavirus disease 2019
Conditions
Interventions
Cohort 1:Subjects undergo nebulization inhalation of investigational drugs (drug or placebo).
Cohort 2:Subjects undergo nebulization inhalation of investigational drugs (drug or placebo).
Cohort 3:Subjects undergo nebulization inhalation of investigational drugs (drug or placebo).
Sponsors
The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: (1) Patients aged =18 years and =70 years; (2) Male or female patients; (3) Patients with documented evidence of infection with novel coronavirus (SARS-CoV-2) at screening: infection confirmed by molecular testing (antigen or nucleic acid) of any respiratory specimen (such as nasal swab or saliva) at screening; (4) Patients diagnosed with mild or moderate COVID-19 (antigen or nucleic acid positive); (5) Patients with COVID-19 target symptoms = 3 days prior to randomization and at least one COVID-19 target symptom still present at the time of randomization (with COVID-19 target symptoms including pyrexia, cough, nasal obstruction or rhinorrhoea, sore throat or dry throat, shortness of breath or dyspnoea, headache, muscle or generalized soreness, diarrhoea, chills, nausea, vomiting, etc.); (6) Patients with Ct values =30 for the N and ORF genes in COVID-19 nucleic acid tests at screening; (7) Patients who agree not to participate in other clinical trials during the study; (8) Patients who commit to having no plans for conception, sperm or egg donation and voluntarily agree to use effective physical contraception measures (including their partners) during the study period and for 6 months after the last dose; (9) Patients who are able to understand the study procedures, possible benefits and potential risks, and voluntarily participate in the study; are able to communicate well with the investigators, comply with the requirements of the entire study, and have signed the written informed consent form (ICF).
Exclusion criteria
Exclusion criteria: Exclusion Criteria: (1) Patients who have received SARS-CoV-2 antiviral drugs within 14 days prior to screening, or who have received (within 30 days prior to randomization or within 5 drug half-lives, whichever is longer) or are expected to receive (during the study) SARS-CoV-2 monoclonal antibody or COVID-19 convalescent plasma; (2) Patients with severe or critical COVID-19 who meet any of the following criteria: a. Polypnoea, with respiratory rate (RR) =30 breaths/min; b. At rest, oxygen saturation = 93% when breathing air; c. Progressive aggravation of clinical symptoms, and significant progression of lesions by more than 50% within 24-48 hours as shown by pulmonary imaging; d. Respiratory failure requiring mechanical ventilation; e. Shock; f. Other concurrent organ failures, etc. (3) Patients with suspected or confirmed acute systemic infection other than COVID-19 (e.g., concomitant influenza suggested by etiology test; high likelihood of bacterial infection based on symptoms, signs, laboratory tests, or imaging) that may interfere with the assessment of response to study intervention at screening; (4) Patients with immunodeficiency (e.g., AIDS, long-term use of corticosteroids or other immunosuppressive drugs); (5) Patients with a history of allergy to any antibody drug, or known allergy to components of the investigational product or placebo; (6) Patients who have received a COVID-19 vaccine within 3 months prior to screening or plan to receive a COVID-19 vaccine during the study; (7) Patients with a history of active pathological haemorrhage (e.g., peptic ulcer, intracranial haemorrhage, etc.), or those with haemorrhagic diathesis (e.g., coagulation disorders, recurrent gingival bleeding, etc.); (8) Patients with laboratory tests that meet the following conditions at screening: a. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or gamma-glutamyltransferase (GGT) =2.5×ULN, and total bilirubin =1.5×ULN; b. Estimated glomerular filtration rate [eGFR] 11.1 mmol/L; d. Haemoglobin (Hb) < 8.0 g/dL; e. Any of the following: platelet count (PLT) < 50×109/L; absolute neutrophil count < 1.0×109/L. (9) Patients who are initially screened positive for human immunodeficiency virus (HIV) and tested positive for treponema pallidum antibodies at screening, or those known to have active liver disease (e.g., acute or chronic hepatitis B, hepatitis C, PBC, hepatic cirrhosis, or acute liver failure, except for nonalcoholic fatty liver disease). (10) Patients who have had major trauma or undergone major surgery within 3 months prior to screening, or have not recovered from surgery, or have undergone surgery that may significantly affect the in vivo process or safety evaluation of the study drug, or are expected to have surgeries planned during the study; (11) Patients who have used other investigational drugs or devices within 90 days prior to screening, or who plan to participate in other drug or device clinical trials during this study; (12) Pregnant or breastfeeding women or those with a positive pregnancy test; (13) Patients with a history of needle sickness and blood sickness, or those who are unsuitable for venous blood collection; (14) Patients with any other factors unsuitable for participation in this study as judged by the investigator, such as other serious diseases (including psychiatric
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To evaluate the mean change from baseline in viral load in nasopharyngeal swabs within 5 days after treatment; ; | — |
Countries
China
Contacts
Public ContactHongzhou Lu
The Third People's Hospital of Shenzhen
Outcome results
None listed