A Phase 3 interventional study of JT001 and JT001 placebo in Moderate to Severe COVID-19, sponsored by Shanghai Vinnerna Biosciences Co., Ltd.. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Shanghai Vinnerna Biosciences Co., Ltd. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of JT001 (VV116) for the Treatment of Coronavirus Disease 2019 (COVID-19) in participants with moderate to severe COVID-19.
Screening Interested participants will sign the appropriate informed consent form (ICF) prior to completion of any study procedures.
The investigator will review symptoms, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. If the participant is eligible after this review, then the site will perform the invasive procedures to confirm eligibility.
Treatment and Assessment Period
This is the general sequence of events during the 29-day treatment and assessment period:
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 290 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shanghai Vinnerna Biosciences Co., Ltd. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who have any of the following conditions when screening:
JT001 (VV116):Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days Favipiravir placebo:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
Drug: JT001 · Drug: Favipiravir placebo
Favipiravir:Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days JT001 (VV116) placebo:Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
Drug: JT001 placebo · Drug: Favipiravir
Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
Also known as: VV116
Day 1: 600mg, Q12H X 1 day; Day 2\~5: 300mg, Q12H X 4 days
Also known as: VV116 placebo
Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
Day 1: 1600mg, Q12H X 1 day; Day 2\~5: 600mg, Q12H X 4 days
progression of COVID-19
Percentage of the participants who have progression of COVID-19, defined as progress to critical COVID-19\* or death from any cause, through Day 29
Time frame: Up to 29 days
AEs and SAEs
Safety assessments such as AEs and SAEs through Day 29
Time frame: Up to 29 days
Progress, Death
Percentage of participants who experience these events by Day 29 * Progress to critical COVID-19 * Death from any cause
Time frame: Up to 29 days
WHO 11-point ordinal outcome scale
The change of WHO 11-point ordinal outcome scale from baseline to Day 3, 5, 7, 10 and 29(0-uninfected,10-dead)
Time frame: Day 3, 5, 7, 10 and 29
The change of Chest CT scan
The change of Chest CT scan from baseline to Day 7 and 10(Percentage of lung involved)
Time frame: Day 7 and 10
SARS-CoV-2 clearance
Percentage of participants achieve SARS-CoV-2 clearance at Day 3, 5 ,7 and 10
Time frame: Day 3, 5 ,7 and 10
SARS-CoV-2 viral genetic variation
SARS-CoV-2 viral genetic variation
Time frame: Day 1
Plan to share: Undecided — Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Vinnerna Biosciences Co., Ltd.