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

A Phase 1, Multi-Center, Open-Label, Safety and Tolerability Study of Intravenous Administration of ST266 in Subjects With Confirmed COVID-19 Infection

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.

Study Overview

• Status: Completed
• Conditions: Cytokine Release Syndrome
• Intervention / Treatment: Biological: ST266

Detailed Description

This clinical trial will utilize a 3+3 enrollment design with sentinel approach.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Clearwater, Florida, United States, 33756
      • Innovative Research of West Florida
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-Clinsearch, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and non-pregnant/non-breastfeeding females age 18-70 years of age.
2. 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).
3. BMI between 18 and 39 inclusive, with a maximum weight of 150 kg (330lbs).
4. Asymptomatic or mildly symptomatic COVID-19 positive subject with a score of 1 or 2 on the WHO 7-point ordinal scale.
5. Subjects with pulse oximetry of > 94% on room air
6. Subjects have controlled blood pressure of < 160/100 mmHg or systolic BP > 90 mmHg (or 20 mmHg less than usual range, whichever is higher)
7. Subjects with pulse < 120 bpm
8. Willingness and ability to comply with study-related procedures and assessments.
9. 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.
10. 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.
11. Subject or subject's legal representative provides written consent prior to the initiation of any Screening or study specific procedures.

Exclusion Criteria:

1. Subjects requiring immediate admission to the hospital due to complications of COVID-19 infection.
2. Subject has an untreated active bacterial, fungal, viral or other infection not related to COVID-19 infection.
3. Subjects with chronic lung diseases of any etiology including idiopathic pulmonary fibrosis, Tuberculosis, COPD, persistent asthma, and pulmonary hypertension.
4. Subjects with a severe history of cardiac disease (such as congestive heart failure, coronary artery disease, cardiac arrhythmia)
5. Subjects with a history of neurological disorders (such as epilepsy, stroke, encephalopathy, Guillain-Barré syndrome)
6. Subjects with D-dimer > 2 ug/mL
7. Subjects with a history of coagulopathy or currently taking anti-coagulation medication
8. Subjects with PTT ≥ 100s or INR ≥ 2.75
9. Malignancy in the last 5 years (except successfully treated basal cell carcinoma).
10. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR < 30).
11. 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).
12. TBIL> 2×ULN, ALT > 3×ULN, AST> 3×ULN, or ALP> 3×ULN.
13. Neutrophils <1000/mm3, PLT<50×10^9/L, or HGB<8g/dL
14. Previous participation in any other interventional clinical trial for the treatment for COVID-19.
15. 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)
16. Use of anti-cancer or immunomodulatory biological drug or kinase inhibitor (e.g., tocilizumab, sarilumab) or, JAK inhibitors (within 30 days of enrollment or five times the half-life [whichever is longer]).
17. Chronic glucocorticosteroid use equivalent to daily oral prednisone > 10 mg per day (10 mg oral prednisone every other day is allowed).
18. Live (live-attenuated) vaccines are not permitted within 2 weeks prior to enrollment or during the study treatment and safety follow-up periods, including the SARS-CoV-2 vaccine (with the exception of the Flu vaccine which is allowed at any time)
19. Subject is pregnant or breastfeeding or plans to become pregnant within 12 months.
20. Subjects with a history of alcohol or drug abuse, or the use of illicit drugs within the 12 months prior to Screening or use of medical marijuana within 1 month prior to Screening.
21. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1; 0.1 ml/kg IV ST266 once a day for 5 days	Biological: ST266; 1X ST266
EXPERIMENTAL: Cohort 2; 0.25 ml/kg IV ST266 once a day for 5 days	Biological: ST266; 1X ST266
EXPERIMENTAL: Cohort 3; 0.5 ml/kg IV ST266 once a day for 5 days	Biological: ST266; 1X ST266
EXPERIMENTAL: Cohort 4; 1.0 ml/kg IV ST266 once a day for 5 days	Biological: ST266; 1X ST266

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Oximetry	Percent improvement in pulse oximetry from Baseline to Day 14	14 days
Fever	Time to resolution of fever	14 days
Clinical Status on Ordinal Scale	Improvement or absence of worsening in clinical status on WHO 7-point ordinal scale from baseline to Day 14	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNFα at Day 6	Change in TNFα from Baseline through Day 6	6 days
IL- 1β at Day 6	Change in IL- 1β from Baseline through Day 6	6 days
IL-6 at Day 6	Change in IL-6 from Baseline through Day 6	6 days
TNFα at Day 14	Change in TNFα from Baseline through Day 14	14 days
IL- 1β at Day 14	Change in IL- 1β from Baseline through Day 14	14 days
IL-6 at Day 14	Change in IL-6 from Baseline through Day 14	14 days

Collaborators and Investigators

• Sponsor: Noveome Biotherapeutics, formerly Stemnion
• Collaborators: IQVIA Biotech
• Investigators: Study Director: David L Steed, MD, Noveome Biotherapeutics, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2021
• Primary Completion (ACTUAL): May 3, 2022
• Study Completion (ACTUAL): May 3, 2022

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 21, 2021
• First Posted (ACTUAL): January 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Shock; COVID-19; Cytokine Release Syndrome
• Other Study ID Numbers: ST266-CRS-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No