Status:
COMPLETED
Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
Lead Sponsor:
RedHill Biopharma Limited
Conditions:
COVID-19
Lung Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
A phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study in Adult Subjects Hospitalized with Severe SARS-CoV-2 Positive Pneumonia to determine the potential of opagan...
Detailed Description
This is a phase 2/3 multi-center randomized, double-blind, parallel arm, placebo- controlled study with an adaptive design that will utilize a futility assessment. The study is planned be performed wo...
Eligibility Criteria
Inclusion
- Adult male or female ≥18 to ≤80 years of age
- Proven COVID-19 infection per RT-PCR assay of a pharyngeal sample (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest X-ray or CT scan. that diagnosed COVID-19 pneumonia. Pharyngeal samples collected either at screening or within 7-days prior to screening for the same ongoing COVID-19 pneumonia illness are acceptable
- The patient requires, at baseline, high flow supplemental oxygen or positive pressure ventilation or is receiving oxygen via face mask, such as a non-rebreather or reservoir mask, capable of delivering high concentrations of oxygen
- Patient agrees to use appropriate methods of contraception during the study and 3 months after the last dose of study drug
- The patient or legal representative has signed a written informed consent approved by the IRB/Ethics Committee
Exclusion
- Any co-morbidity that may add risk to the treatment in the judgment of the investigator, particularly patients with known cardiac conditions, and serious neuropsychiatric conditions such as psychosis or major depression
- Requiring intubation and mechanical ventilation at baseline
- Patient has a 'Do Not Intubate' and/or 'Do Not Resuscitate' order in place
- Oxygen saturation \>95% on room air
- Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
- Patient is, in the investigator's clinical judgement, unlikely to survive \>72 hours
- Pregnant (positive serum or urine test within 3 days prior to randomization) or nursing women .
- Unwillingness or inability to comply with procedures required in this protocol.
- Corrected QT (QTc) interval on electrocardiogram (ECG) \>470 ms for females or \>450 ms for males, calculated using Friedericia's formula (QTcF)
- AST (SGOT) or ALT (SGPT) \> 2.0 x upper limit of normal (ULN)
- Total bilirubin \>1.5x ULN (except where bilirubin increase is due to Gilbert's Syndrome)
- Serum creatinine \>2.0 X ULN
- Absolute neutrophil count \<1000 cells/mm3
- Platelet count \<75,000/mm3
- Hemoglobin \<8.0 g/dL
- Medications that are sensitive substrates, or substrates with a narrow therapeutic range, for CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 CYP2D6 , CYP3A4, P-gP, BCRP and OATP1B1 should be avoided with opaganib
- Moderate or strong inhibitors of CYP1A2, CYP3A4, CYP2D6 or P-gP or moderate to strong inducers of CYP3A4 and CYP1A2 are prohibited
- Currently taking warfarin, apixaban, argatroban or rivaroxaban due to drug-drug interaction based on CYP450 metabolism
- Current drug or alcohol abuse
- Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies
- Treatment with any medication that causes QT prolongation within seven days, or 5 half-lives, whichever is longest, prior to initiation of study drug, or intention to use them throughout the study, including but not limited to: amiodarone, amitriptyline, citalopram dose greater than 20 mg/day, dihydroergotamine, disopyramide, dofetilide, dronedarone, ergotamine, ibutilde, ondansetron or other 5-HT3 receptor antagonists, pimozide, procainamide, quinidine, quinine, quinolone, ranolazine, risperidone, sotaloland tolteridine. Investigators are directed to the following up-to-date web site listing QT prolonging drugs: https://www.crediblemeds.org/index.php/drugsearch
Key Trial Info
Start Date :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2021
Estimated Enrollment :
475 Patients enrolled
Trial Details
Trial ID
NCT04467840
Start Date
August 21 2020
End Date
July 18 2021
Last Update
July 31 2025
Active Locations (57)
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1
ABC-201 Site 901
Detroit, Michigan, United States, 00000
2
ABC-201 Site 408
Belo Horizonte, Brazil
3
ABC-201 Site 411
Belo Horizonte, Brazil
4
ABC-201 Site 405
Joinville, Brazil