Status:
COMPLETED
Safety and Tolerability Study of IV ST266 in COVID-19 Subjects
Lead Sponsor:
Noveome Biotherapeutics, formerly Stemnion
Collaborating Sponsors:
IQVIA Biotech
Conditions:
Cytokine Release Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 da...
Detailed Description
This clinical trial will utilize a 3+3 enrollment design with sentinel approach.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04720378
Start Date
May 30 2021
End Date
May 3 2022
Last Update
June 15 2022
Active Locations (3)
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1
Innovative Research of West Florida
Clearwater, Florida, United States, 33756
2
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
3
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421