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Immunomodulator
F-652 for Coronavirus
Phase 2
Waitlist Available
Led By Christine M Bojanowski, MD
Research Sponsored by Generon (Shanghai) Corporation Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1 before dose to day 29
Summary
This trial tests a new medicine called F-652 in adults with serious COVID-19 symptoms. It aims to see if F-652 can help these patients recover faster and reduce the severity of their illness. The medicine is given through an IV infusion.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study day 1 before dose to day 29
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1 before dose to day 29
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
NIAID 8-point Ordinal Scale
Side effects data
From 2018 Phase 1 & 2 trial • 18 Patients • NCT0265551033%
Pruritus
17%
Increased body temperature
17%
Thrombocytosis
17%
Hyperbilirubinaemia
17%
Constipation
17%
Muscle Weakness
17%
Leukocytosis
17%
Fever
17%
Nausea
17%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2: F-652 30 μg/kg
Period 3: F-652 45 μg/kg
Period 1: F-652 10 μg/kg
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: F-652Experimental Treatment1 Intervention
Patient receives standard care plus F-652
Group II: PlaceboPlacebo Group1 Intervention
Patient receives standard care plus placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
F-652
2016
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
Generon (Shanghai) Corporation Ltd.Lead Sponsor
9 Previous Clinical Trials
1,244 Total Patients Enrolled
EVIVE BiotechnologyLead Sponsor
10 Previous Clinical Trials
1,244 Total Patients Enrolled
Christine M Bojanowski, MDPrincipal InvestigatorTulane University
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