Safety and Tolerability Study of IV ST266 in COVID-19 Subjects

NCT04720378 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ST266-CRS-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cytokine Release Syndrome

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence and Severity of Treatment-Emergent Adverse Events

  Determine the incidence and severity of treatment-emergent adverse events related to the IV administration of ST266 based on findings from physical examinations, laboratory evaluations, vital signs, and ECG measurements.

  3 months

Secondary Outcomes (3)

• Pulse Oximetry

  14 days

• Fever

  14 days

• Clinical Status on Ordinal Scale

  14 days

Other Outcomes (6)

• TNFα at Day 6

  6 days

• IL- 1β at Day 6

  6 days

• IL-6 at Day 6

  6 days

Study Arms (4)

Cohort 1

EXPERIMENTAL

0.1 ml/kg IV ST266 once a day for 5 days

Biological: ST266

Cohort 2

EXPERIMENTAL

0.25 ml/kg IV ST266 once a day for 5 days

Biological: ST266

Cohort 3

EXPERIMENTAL

0.5 ml/kg IV ST266 once a day for 5 days

Biological: ST266

Cohort 4

EXPERIMENTAL

1.0 ml/kg IV ST266 once a day for 5 days

Biological: ST266

Interventions

ST266 BIOLOGICAL

1X ST266

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant/non-breastfeeding females age 18-70 years of age.
• Laboratory confirmed SARS-CoV-2 infection determined by PCR or other commercial/public health assay (test results must be obtained within 7-days of the Screening Visit).
• BMI between 18 and 39 inclusive, with a maximum weight of 150 kg (330lbs).
• Asymptomatic or mildly symptomatic COVID-19 positive subject with a score of 1 or 2 on the WHO 7-point ordinal scale.
• Subjects with pulse oximetry of \> 94% on room air
• Subjects have controlled blood pressure of \< 160/100 mmHg or systolic BP \> 90 mmHg (or 20 mmHg less than usual range, whichever is higher)
• Subjects with pulse \< 120 bpm
• Willingness and ability to comply with study-related procedures and assessments.
• If female, subjects must use an effective method of birth control or abstain from sexual relations with a male partner (unless has undergone tubal ligation or is 1 year postmenopausal) for their duration of study participation.
• If male, subjects must use an effective method of birth control or abstain from sexual relations with a female partner (unless has undergone a vasectomy and it has been more than 6 months) for their duration of study participation.
• Subject or subject's legal representative provides written consent prior to the initiation of any Screening or study specific procedures.

You may not qualify if:

• Subjects requiring immediate admission to the hospital due to complications of COVID-19 infection.
• Subject has an untreated active bacterial, fungal, viral or other infection not related to COVID-19 infection.
• Subjects with chronic lung diseases of any etiology including idiopathic pulmonary fibrosis, Tuberculosis, COPD, persistent asthma, and pulmonary hypertension.
• Subjects with a severe history of cardiac disease (such as congestive heart failure, coronary artery disease, cardiac arrhythmia)
• Subjects with a history of neurological disorders (such as epilepsy, stroke, encephalopathy, Guillain-Barré syndrome)
• Subjects with D-dimer \> 2 ug/mL
• Subjects with a history of coagulopathy or currently taking anti-coagulation medication
• Subjects with PTT ≥ 100s or INR ≥ 2.75
• Malignancy in the last 5 years (except successfully treated basal cell carcinoma).
• Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR \< 30).
• Subjects with a reactive or positive screening test result For Hepatitis A virus immunoglobulin M (HAV IgM), Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus Antibody (HCVAb) or Human Immunodeficiency Virus Antibody (HIVAb).
• TBIL\> 2×ULN, ALT \> 3×ULN, AST\> 3×ULN, or ALP\> 3×ULN.
• Neutrophils \<1000/mm3, PLT\<50×10\^9/L, or HGB\<8g/dL
• Previous participation in any other interventional clinical trial for the treatment for COVID-19.
• Subject actively participating in any other clinical study (with the exception of observational studies where there is no intervention with an investigational product or device)

Sponsors & Collaborators

• Noveome Biotherapeutics, formerly Stemnion: lead
• IQVIA Biotech: collaborator

Study Sites (3)

Innovative Research of West Florida

Clearwater, Florida, 33756, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

MeSH Terms

Conditions

Cytokine Release Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David L Steed, MD

  Noveome Biotherapeutics, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 22, 2021
• Study Start: May 30, 2021
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: June 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)