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

• ClinicalTrials.gov Identifier: NCT04720378
• Recruitment Status: Active, not recruiting
• First Posted: January 22, 2021
• Last Update Posted: February 21, 2022
• Sponsor: Noveome Biotherapeutics, formerly Stemnion
• Collaborator: IQVIA Biotech
• Information provided by (Responsible Party): Noveome Biotherapeutics, formerly Stemnion

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cytokine Release Syndrome	Biological: ST266	Phase 1

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Multi-Center, Open-Label, Safety and Tolerability Study of Intravenous Administration of ST266 in Subjects With Confirmed COVID-19 Infection
• Actual Study Start Date: May 30, 2021
• Estimated Primary Completion Date: May 2022
• Estimated Study Completion Date: May 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Incidence and Severity of Treatment-Emergent Adverse Events [ Time Frame: 3 months ]
   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.

Secondary Outcome Measures :

1. Pulse Oximetry [ Time Frame: 14 days ]
   Percent improvement in pulse oximetry from Baseline to Day 14
2. Fever [ Time Frame: 14 days ]
   Time to resolution of fever
3. Clinical Status on Ordinal Scale [ Time Frame: 14 days ]
   Improvement or absence of worsening in clinical status on WHO 7-point ordinal scale from baseline to Day 14

Other Outcome Measures:

1. TNFα at Day 6 [ Time Frame: 6 days ]
   Change in TNFα from Baseline through Day 6
2. IL- 1β at Day 6 [ Time Frame: 6 days ]
   Change in IL- 1β from Baseline through Day 6
3. IL-6 at Day 6 [ Time Frame: 6 days ]
   Change in IL-6 from Baseline through Day 6
4. TNFα at Day 14 [ Time Frame: 14 days ]
   Change in TNFα from Baseline through Day 14
5. IL- 1β at Day 14 [ Time Frame: 14 days ]
   Change in IL- 1β from Baseline through Day 14
6. IL-6 at Day 14 [ Time Frame: 14 days ]
   Change in IL-6 from Baseline through Day 14

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Innovative Research of West Florida

Clearwater, Florida, United States, 33756

United States, Illinois

Great Lakes Clinical Trials

Chicago, Illinois, United States, 60640

United States, Tennessee

WR-ClinSearch, LLC

Chattanooga, Tennessee, United States, 37421

Sponsors and Collaborators

Noveome Biotherapeutics, formerly Stemnion

IQVIA Biotech

Investigators

• Study Director: David L Steed, MD; Noveome Biotherapeutics, Inc

More Information

• Responsible Party: Noveome Biotherapeutics, formerly Stemnion
• ClinicalTrials.gov Identifier: NCT04720378
• Other Study ID Numbers: ST266-CRS-101
• First Posted: January 22, 2021
• Last Update Posted: February 21, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Noveome Biotherapeutics, formerly Stemnion:

COVID-19

Additional relevant MeSH terms:

COVID-19; Cytokine Release Syndrome; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock