Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: COVID-19, Lung Infection
In brief
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 opaganib to improve and/or stabilize the clinical status of the patient.
Key facts
- Study ID
- NCT04467840
- Run by
- RedHill Biopharma Limited
- People needed
- 475
- Starts
- 2020-08-21
- Expected to finish
- 2021-07-18
- Last updated by the study team
- 2025-07-31
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- ABC-201 Site 408 — Belo Horizonte, Brazil
- ABC-201 Site 411 — Belo Horizonte, Brazil
- ABC-201 Site 405 — Joinville, Brazil
- ABC-201 Site 404 — Paraná, Brazil
- ABC-201 Site 410 — Passo Fundo, Brazil
- ABC-201 Site 409 — Porto Alegre, Brazil
- ABC-201 Site 402 — São Bernardo do Campo, Brazil
- ABC-201 Site 401 — São Paulo, Brazil
- ABC-201 Site 403 — São Paulo, Brazil
- ABC-201 Site 407 — Tubarão, Brazil
- ABC-201 Site 604 — Medellín, Antioquia, Colombia
- ABC-201 Site 603 — Bogotá, Colombia
- ABC-201 Site 605 — Cundinamarca, Colombia
- ABC-201 Site 602 — Medellín, Colombia
- ABC-201 Site 601 — Santiago de Cali, Colombia
- ABC-201 Site 708 — Ashkelon, Ashketon, Israel
- ABC-201 Site 702 — Ashdod, Israel
- ABC-201 Site 704 — Holon, Israel
- ABC-201 Site 701 — Jerusalem, Israel
- ABC-201,Site 709 — Kfar Saba, Israel
- ABC-201 Site 705 — Nahariya, Israel
- ABC-201 Site 706 — Nazareth, Israel
- ABC-201 Site 703 — Safed, Israel
- ABC-201 Site 203 — Alessandria, Italy
- ABC-201 Site 901 — Detroit, Michigan, United States
Full record on ClinicalTrials.gov
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