EUCTR2020-004571-41-HUActive, not recruitingPhase 1
A Randomized, Placebo Controlled, Double Blind Study to Evaluate the Safety and Efficacy of Rabeximod Compared to Standard of Care in Patients With Moderate Coronavirus Disease (COVID-19)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Cyxone AB
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.Moderate severity of COVID -19 (See Appendix 2, FDA severity categorization)
- •4.Currently hospitalized or requiring hospitalization for the COVID-19 medical care
- •5.Age >18 and <85 years
- •6.Presence of at least 3 of the following symptoms as present: fever, cough, myalgia, fatigue
- •7.Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate = 20 breaths per minute, saturation of oxygen (SpO2) > 93%, heart rate = 90 beats per minute = 2 days before screening
- •8.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
- •1.Pregnant, or intend to become pregnant or breastfeed during the study.
- •2.Patients who are unable to swallow the capsule.
- •3.Require 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 <1000 cells/mLµL).
- •14.Have lymphopenia (absolute lymphocyte count <200 cells/mLµL).
- •15.Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >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
Investigators
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