COVID-19 infection
Conditions
Interventions
YKYY017 for inhalation group 1 (The first stage):YKYY017 for inhalation: administered via aerosol inhalation one dose of the study drug, one dose of placebo
YKYY017 for inhalation group 2 (The first stage):YKYY017 for inhalation: administered via aerosol inhalation the study drug twice daily
Placebo 1 (The first stage):A placebo of YKYY017 for inhalation was administered via aerosol inhalation,twice daily
YKYY017 for inhalation group 3 (The second stage):YKYY017 for inhalation was administered via aerosol inhalation (dosage was determined based on Phase II (first stage) study results)
Placebo 2 (The second stage):A placebo of YKYY017 for inhalation was administered via aerosol inhalation
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age of the subjects at the time of signing the informed consent form (ICF) should be >= 18 years and = 2 points (COVID-19-related symptom scoring scale). 3. The time from the first appearance of symptoms (the first symptom of the 14 COVID-19-related symptoms) to the first administration of the investigational drug should be <= 72 hours. 4. The subjects should have a positive nucleic acid test or rapid antigen test for SARS-CoV-2 virus at the time of screening. 5. Mild or moderate COVID-19 (the severity of the disease is referred to in Appendix II). 6. The subjects agree to take effective contraceptive measures from the time of signing the informed consent form to at least 30 days after the last dose (applicable to women of childbearing age) or 90 days (applicable to adult men). 7.The subjects understand and agree to comply with the planned research procedures (including treatment plan, visit schedule, laboratory tests, lifestyle precautions, etc.), and the subjects or their legally authorized representatives are willing to sign the written ICF.
Exclusion criteria
Exclusion criteria: 1. The researcher determined that the subject was about to progress to severe/critical COVID-19 before randomization. 2. The subject's pulse oxygen saturation (SpO2) at rest in room air was = 30 breaths per minute. 3. The researcher assessed that the subject urgently needed or was expected to need nasal high-flow oxygen therapy or non-invasive positive pressure ventilation, invasive mechanical ventilation, or ECMO. 4. The subject was using or was scheduled to use other SARS-CoV-2 antiviral drugs, or convalescent plasma therapy for COVID-19, or any other type of treatment measure that the researcher considered incompatible with this study in terms of science or medicine. 5. The subject had participated in a clinical study involving drug intervention within the past 30 days. If the half-life of the previous study drug intervention was long, a period of 5 half-lives or 30 days (whichever was longer) should have elapsed. 6. The subject had received any COVID-19 vaccine within the 3 months prior to randomization, or had been infected with the novel coronavirus within the past 3 months. 7. Known to have chronic liver disease (Child-Pugh grade B or C); or known to have chronic kidney disease (CKD stage >= 4). 8. The subject had any comorbidities that required surgery within 14 days before randomization, or had life-threatening comorbidities within 30 days before randomization as determined by the researcher, or had undergone surgery of grade II or above within the past 3 months. 9. Had an allergic reaction to any component of the study intervention or other contraindications. 10. Known to have severe chronic respiratory diseases [previously diagnosed chronic obstructive pulmonary disease GOLD E stage, uncontrolled asthma or asthma requiring high-dose inhaled glucocorticoids for control, previously known interstitial lung disease or pulmonary arterial hypertension and other chronic respiratory diseases with dyspnea after activity], or known to have an immunocompromised state [active autoimmune disease, or using drugs that can cause immunosuppression, or immunodeficiency (such as malignant tumors, organ or bone marrow transplantation, HIV infection, etc.), and other diseases that can cause immunocompromise], or suspected or confirmed acute systemic infections other than COVID-19 (such as influenza, sepsis, systemic fungal disease, etc.), or clinical symptoms/signs suggesting severe systemic disease caused by COVID-19. 11. At the time of screening, the subject had an acute disease that had not been cured, or was in the acute phase of a chronic disease, or had a serious chronic disease [including cardiovascular and cerebrovascular diseases: subjects who were hospitalized due to acute cardiovascular and cerebrovascular events within 3 months, including stroke, acute coronary syndrome (acute myocardial infarction and unstable angina pectoris, etc.), or chronic cardiovascular and cerebrovascular diseases that affected life functions and could not cooperate with the study follow-up as determined by the researcher (such as severe paralysis, NYK grade III and above), hypertension: hypertensive emergency or hypertensive crisis and other hypertension conditions that required immediate hospitalization at the time of screening, active malignant tumor diseases: malignant tumor diseases that received radiothe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The period from the beginning of treatment to the complete clinical recovery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in viral load compared to the baseline of the SARS-CoV-2 ;The rate of negative conversion of SARS-CoV-2 viral nucleic acid after the start of treatment;The rebound rate of SARS-CoV-2 viral load;The change in the expression level of MxA compared to the baseline;The period from the beginning of treatment until the complete relief of symptoms;The duration from the onset of each COVID-19-related symptom to the complete clinical recovery;The changes in the COVID-19-related symptom scores of subjects D1 to D28;The number and proportion of cases where the subjects D1 to D28 experienced disease progression (developed to severe or critical severity or died from all causes) during the observation period;The rebound rate of COVID-19-related symptoms (11 symptoms); | — |
Countries
China
Contacts
Public ContactWang Chen,Chao Bin
China-Japan Friendship Hospital
Outcome results
None listed