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Immunomodulator

Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19

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 weeks
Treatment ~ Varies
Follow Up ~study day 1 before dose to day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 1 before dose to day 29 for reporting.

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 • NCT02655510
33%
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
~0 spots leftby Dec 2025
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