Coronavirus Disease (COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084401 Term: COVID-19 respiratory infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Rabeximod
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Rabeximod
CAS Number: 872178-65-9
Current Sponsor code: Rabeximod (Manufacturer’s code OXY-001)
Other descriptive name:
Sponsors
Cyxone AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent prior to performing study procedures 2. SARS-CoV-2 positivity of the nasal/throat-swab/saliva swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory = 4 days before randomization 3. Currently hospitalized or requiring hospitalization for the COVID-19 medical care 4. Age >18 and 93%, with or without oxygen therapy = 2 days before screening 7. Agree to use an acceptable method of contraception for the duration of the study or not be of childbearing potential. Acceptable methods of birth control include: spermicide with barrier, oral, transdermal, injectable, or implantable contraception, IUD, abstinence, and surgical sterilization of partner. Female subjects are not of childbearing potential if they have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, or are post-menopausal by at least 12 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Pregnant, or intend to become pregnant or breastfeed during the study. 2. Patients who are unable to swallow the capsule. 3. Require supplemental high-flow oxygen, invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry. 4. Receiving cytotoxic or biologic treatments (such as tumor necrosis factor (TNF) inhibitors, anti-interleukin-1 (IL-1), anti-IL-6 (tocilizumab or sarilumab), T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry. A washout period 4 weeks (or 5 half-lives, whichever is longer) is required prior to screening. 5. Ever received convalescent plasma or intravenous immunoglobulin (IVIg) for COVID-19. 6. Have received high dose corticosteroids at doses >20 mg per day (or prednisone equivalent) administered for =14 consecutive days in the month prior to study entry. 7. Have diagnosis of primary tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required). 8. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product. 9. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Use of non-live (inactivated) vaccinations is allowed 10. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product. 11. Have a history of venous thromboembolism (VTE) (deep vein thrombosis (DVT) and pulmonary embolism (PE) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE). 12. Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry. 13. Have neutropenia (absolute neutrophil count 5x ULN. 16. Have total bilirubin > 1.5 x upper limit of normal. 17. Estimated glomerular filtration rate (eGFR) <30 milliliter/minute/1.73 m2. 18. Have a known hypersensitivity to rabeximod or any of its excipients. 19. Are currently enrolled in any other clinical study involving an investigation product or any other type of medical research judged not to be scientifically or medically compatible with this study. The participant should not be enrolled (start) in another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28. 20. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®. 21. Are unlikely to survive for at least 48 hours after screening in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy and tolerability of rabeximod in the treatment of patients with moderate Covid-19.;Secondary Objective: Not applicable;Primary end point(s): Proportion of subjects alive and free of respiratory failure (need for invasive mechanical ventilation, non-invasive ventilation, high-flow nasal cannula oxygen, or ECMO) at Day 28.;Timepoint(s) of evaluation of this end point: 28th day | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: at Day 7, Day 14, Day 28, Day 60;Secondary end point(s): 1.Time to response (TTR) (in days).Response to treatment is defined as the reduction of at least one severity level on the World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI). The WHO-OSCI is an ordinal scale of 9 severity levels (from 0 to 8) for COVID-19 (please see Appendix 1). This will be a continuous outcome defined by the amount of time between randomization to the first response, it will be treated as a time-to-event with possible censoring. 2. To evaluate the impact of rabeximod on the clinical, laboratory, respiratory parameters and viral load, the following clinical and respiratory parameters will be assessed: • ICU admission rate. The percentage of patients admitted to the ICU in the rabeximod group as compared with controls (Time frame: Day 60) • Discharge rate. The percentage of patients discharged in the rabeximod group as compared with controls. (Time frame: Day 28) • Duration (cumulative days) of mechanical ventilation (Time frame: Day 60) • Duration (cumulative days) of extracorporeal membrane oxygenation (Time frame: Day 60) • Duration (cumulative days) of supplemental oxygenation (Time frame: Day 60) • Time to SARS-CoV-2 RT-PCR negativity in upper respiratory tract specimens (Time frame: Day 28) • Change (reduction) in SARS-CoV-2 viral load in upper respiratory tract specimens as assessed by area under viral load curve (Time frame: Day 28 compared to baseline) • Mortality rate at Day 7, Day 14, Day 28, Day 60 • To assess the safety of rabeximod combined with standard of care therapy in terms of serious or non-serious adverse events incidence rate. All adverse event recording. | — |
Countries
Hungary, Latvia, Poland, Romania, Slovakia, Ukraine
Contacts
Public ContactCOO
AS EGeen
Outcome results
None listed