A Study of JT001 (VV116) for the Early Treatment of Mild to Moderate COVID-19

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2023
INTERVENTION: JT001 drug Placebo CONDITION: ; Respiratory Respiratory PRIMARY OUTCOME: Characterize the effect of JT001 (VV116) compared to placebo on overall participant clinical status; SECONDARY OUTCOME: 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 safety 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) 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 exa
Epistemonikos ID: 4008401fc705c53849d90ae77622c4957411217c
First added on: Oct 02, 2023