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

Completed · Phase 1

Conditions studied: Cytokine Release Syndrome

In brief

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.

Key facts

Study ID

NCT04720378

Run by

Noveome Biotherapeutics, formerly Stemnion

People needed

12

Starts

2021-05-30

Expected to finish

2022-05-03

Last updated by the study team

2022-06-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)
• 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]).
• Chronic glucocorticosteroid use equivalent to daily oral prednisone > 10 mg per day (10 mg oral prednisone every other day is allowed).
• 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)
• Subject is pregnant or breastfeeding or plans to become pregnant within 12 months.
• 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.
• Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.

Where it is running

• Innovative Research of West Florida — Clearwater, Florida, United States
• Great Lakes Clinical Trials — Chicago, Illinois, United States
• WR-ClinSearch, LLC — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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