Respiratory
Conditions
Interventions
JT001 drug
Placebo
Sponsors
Shanghai JunTop Biosciences Co LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants of 18 years of age or older, at the time of signing of informed consent Participants who have a positive SARS-CoV-2 test result, and have sample collection for first positive SARS-CoV-2 viral infection determination =5 days prior to randomization Participants who have one or more mild or moderate COVID-19 symptoms as follows and have a COVID-19 Related Symptom score =3 ? fever ? cough ? sore throat ? stuffy or running nose, ? headache ? muscle pain ? shortness of breath or difficulty breathing ? nausea Chills or shivering ? vomiting ? diarrhea Participants with the onset of symptoms of COVID-19 =5 days prior to randomization Participants who satisfy one or more than one of the following high risks for progression to severe COVID-19, including death: ? Are = 60 years of age ? Cardiovascular disease (including congenital heart disease and hypertension) ? Chronic lung diseases (for example, chronic obstructive pulmonary disease (COPD), asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension) ? Diabetes ? Immunosuppressive disease or immunosuppressive treatment(for example,long-term use of corticosteroids or other immunosuppressive drugs lead to decreased immune function) ? Overweight or obesity BMI>25 kg/m2 ? Sickle cell disease ? Active cancer ? Chronic kidney disease ? Current smoker ? Neurodevelopmental disorders (e.g., cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (e.g., genetic or metabolicsyndromes and severe congenital anomalies) ? Need relevant medical support (not related to COVID-19) (such as tracheotomy, gastrostomy or positive pressure ventilation, etc.) Participants who must agree to adhere to contraception restrictions Participants who understand and agree to comply with planned study procedures Participants can give written informed consent approved by the Ethical Review Board governing the site and comply with the requirements and restrictions l
Exclusion criteria
Exclusion criteria: Participants who are judged by the investigator as likely to progress to severe/critical COVID-19 prior to randomization. Participants who have SpO2=93% on room air at sea level or PaO2/FiO2= 300(with oxygen inhalation), or respiratory rate =30 per minute, or heart rate =125 per minute Participants who require mechanical ventilation or anticipated impending need for mechanical ventilation Participants who are suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention Participants who have eye disease (such as inflammation, vessel deformity, retinal hemorrhage or decollement, optic nerve lesion, or fundus lesion) Participants who have ALT or AST>2 ULN at screening Participants who have known allergies to any of the components used in the formulation of the interventions Any medical condition, which in the opinion of the Investigator, will compromise the safety of the participant Participants who have received a SARS-CoV-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment) within180 days prior to screening visit Participants who have received convalescent COVID-19 plasma treatment within180 days prior to screening visit Participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed Participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study Female who is pregnant or breast-feeding or plan to be pregnant within this study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize the effect of JT001 (VV116) compared to placebo on overall participant clinical status | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the effect of JT001 (VV116) compared to placebo on COVID-19-related hospitalization rate of non-hospitalized participants;Characterize the effect of JT001 (VV116) compared to placebo on SARS-CoV-2 negative rate ;Characterize the effect of JT001 (VV116) compared to placebo on the plasma concentration of JT001 (VV116) and major metabolites when administered orally to participants (optional);Characterize the effect of JT001 (VV116) compared to placebo on safety | — |
Countries
Nigeria
Contacts
Public ContactMichelle Botha
Associate Director
Outcome results
None listed