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Virus Therapy

ST266 for Cytokine Release Syndrome

Phase 1
Waitlist Available
Research Sponsored by Noveome Biotherapeutics, formerly Stemnion
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 3 months
Awards & highlights

Summary

The primary aim of the study is to evaluate the safety and tolerability of open-label ST266 given to subjects with confirmed COVID-19 infection through IV administration once a day of 5 consecutive days.

Eligible Conditions
  • Cytokine Release Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and Severity of Treatment-Emergent Adverse Events
Secondary outcome measures
Clinical Status on Ordinal Scale
Fever
Pulse Oximetry
Other outcome measures
IL- 1β at Day 14
IL- 1β at Day 6
IL-6 at Day 14
+3 more

Side effects data

From 2017 Phase 2 trial • 151 Patients • NCT02761993
6%
Sensitivity of teeth
6%
Blood pressure increased
4%
Palatal disorder
4%
Gingival erythema
4%
Dental fistula
4%
Toothache
4%
Burn oral cavity
4%
Tooth fracture
4%
Thermal burn
4%
Gingival pain
2%
Pancreatic carcinoma
2%
Nasopharyngitis
2%
Cholecystitis
2%
Mouth injury
2%
Lip haematoma
2%
Dental discomfort
2%
Gingival oedema
2%
Hypoaesthesia oral
2%
Blood pressure diastolic decreased
2%
Lip injury
2%
Dyspepsia
2%
Headache
2%
Dry mouth
2%
Lip swelling
2%
Oral mucosal discolouration
2%
Influenza
2%
Tooth loss
2%
Gastroenteritis viral
2%
Angular cheilitis
2%
Gastroenteritis norovirus
2%
Pneumonia
2%
Muscle strain
2%
Contusion
2%
Blood pressure decreased
2%
Lymphocyte count increased
2%
Monocyte count decreased
2%
Neutrophil count decreased
2%
White blood cell count decreased
2%
Pain in jaw
2%
Arthralgia
2%
Dizziness
2%
Device damage
2%
Adverse drug reaction
2%
Complication associated with device
2%
Oral disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 3
Group 1
Group 2

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment1 Intervention
1.0 ml/kg IV ST266 once a day for 5 days
Group II: Cohort 3Experimental Treatment1 Intervention
0.5 ml/kg IV ST266 once a day for 5 days
Group III: Cohort 2Experimental Treatment1 Intervention
0.25 ml/kg IV ST266 once a day for 5 days
Group IV: Cohort 1Experimental Treatment1 Intervention
0.1 ml/kg IV ST266 once a day for 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ST266
2016
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Noveome Biotherapeutics, formerly StemnionLead Sponsor
12 Previous Clinical Trials
418 Total Patients Enrolled
IQVIA BiotechIndustry Sponsor
20 Previous Clinical Trials
5,723 Total Patients Enrolled
David L Steed, MDStudy DirectorNoveome Biotherapeutics, Inc
4 Previous Clinical Trials
100 Total Patients Enrolled
~3 spots leftby Sep 2025
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