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

June 14, 2022 updated by: Noveome Biotherapeutics, formerly Stemnion

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Clearwater, Florida, United States, 33756
        • Innovative Research of West Florida
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Great Lakes Clinical Trials
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulse Oximetry
Time Frame: 14 days
Percent improvement in pulse oximetry from Baseline to Day 14
14 days
Fever
Time Frame: 14 days
Time to resolution of fever
14 days
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
14 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TNFα at Day 6
Time Frame: 6 days
Change in TNFα from Baseline through Day 6
6 days
IL- 1β at Day 6
Time Frame: 6 days
Change in IL- 1β from Baseline through Day 6
6 days
IL-6 at Day 6
Time Frame: 6 days
Change in IL-6 from Baseline through Day 6
6 days
TNFα at Day 14
Time Frame: 14 days
Change in TNFα from Baseline through Day 14
14 days
IL- 1β at Day 14
Time Frame: 14 days
Change in IL- 1β from Baseline through Day 14
14 days
IL-6 at Day 14
Time Frame: 14 days
Change in IL-6 from Baseline through Day 14
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Noveome Biotherapeutics, formerly Stemnion

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
IQVIA Biotech

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David L Steed, MD, Noveome Biotherapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ST266-CRS-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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