Cytokine Release SyndromePhase 1NCT04720378
Safety and Tolerability Study of IV ST266 in COVID-19 Subjects
A Phase 1 study testing ST266 in people with Cytokine Release Syndrome, run by Noveome Biotherapeutics, formerly Stemnion at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cytokine Release Syndrome
- What is being tested?
- ST266
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 May 2021to 3 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421
Great Lakes Clinical Trials
Chicago, Illinois, 60640
Innovative Research of West Florida
Clearwater, Florida, 33756
About this study
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
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.
Read the detailed description
This clinical trial will utilize a 3+3 enrollment design with sentinel approach.
- Conditions
- Cytokine Release Syndrome
- Being tested
- ST266
- Keywords
- COVID-19
- Medical subject headings
- Cytokine Release Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST266Biological
1X ST266
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 0.1 ml/kg IV ST266 once a day for 5 days Receives: Biological: ST266 |
| Cohort 2 | Experimental | 0.25 ml/kg IV ST266 once a day for 5 days Receives: Biological: ST266 |
| Cohort 3 | Experimental | 0.5 ml/kg IV ST266 once a day for 5 days Receives: Biological: ST266 |
| Cohort 4 | Experimental | 1.0 ml/kg IV ST266 once a day for 5 days Receives: Biological: ST266 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
Pulse Oximetry
Percent improvement in pulse oximetry from Baseline to Day 14
Measured: 14 days
Fever
Time to resolution of fever
Measured: 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
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start30 May 2021
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine Release SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noveome Biotherapeutics, formerly Stemnion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Biotech
- Responsible party
- Sponsor
- Investigators
- David L Steed, MD, Study director, Noveome Biotherapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720378
- Sponsor's protocol ID
- ST266-CRS-101
- Status last verified
- Jun 2022
- First submitted
- 21 Jan 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04720378
- Acronym / sponsor ID
- ST266-CRS-101
- Conditions
- Cytokine Release Syndrome
- Keywords
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Noveome Biotherapeutics, formerly StemnionIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Biotech
- Study start
- 30 May 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial will utilize a 3+3 enrollment design with sentinel approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: ST2660.1 ml/kg IV ST266 once a day for 5 days |
| Cohort 2 | Experimental | Biological: ST2660.25 ml/kg IV ST266 once a day for 5 days |
| Cohort 3 | Experimental | Biological: ST2660.5 ml/kg IV ST266 once a day for 5 days |
| Cohort 4 | Experimental | Biological: ST2661.0 ml/kg IV ST266 once a day for 5 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST2661X ST266 | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
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.
3 secondary outcomes
Pulse Oximetry
Time frame: 14 days
Fever
Time frame: 14 days
Clinical Status on Ordinal Scale
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Steed, MD study director
Noveome Biotherapeutics, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ST266 in people with Cytokine Release Syndrome, run by Noveome Biotherapeutics, formerly Stemnion at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Treatment-Emergent Adverse Events (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.