Safety and Tolerability Study of IV ST266 in COVID-19 Subjects
Study Details
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 |
|---|---|---|
|
Phase 1 |
Detailed Description
This clinical trial will utilize a 3+3 enrollment design with sentinel approach.
Study Design
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
- Incidence and Severity of Treatment-Emergent Adverse Events [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
- Pulse Oximetry [14 days]
Percent improvement in pulse oximetry from Baseline to Day 14
- Fever [14 days]
Time to resolution of fever
- Clinical Status on Ordinal Scale [14 days]
Improvement or absence of worsening in clinical status on WHO 7-point ordinal scale from baseline to Day 14
Other Outcome Measures
- TNFα at Day 6 [6 days]
Change in TNFα from Baseline through Day 6
- IL- 1β at Day 6 [6 days]
Change in IL- 1β from Baseline through Day 6
- IL-6 at Day 6 [6 days]
Change in IL-6 from Baseline through Day 6
- TNFα at Day 14 [14 days]
Change in TNFα from Baseline through Day 14
- IL- 1β at Day 14 [14 days]
Change in IL- 1β from Baseline through Day 14
- IL-6 at Day 14 [14 days]
Change in IL-6 from Baseline through Day 14
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- Noveome Biotherapeutics, formerly Stemnion
- IQVIA Biotech
Investigators
- Study Director: David L Steed, MD, Noveome Biotherapeutics, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ST266-CRS-101