Overview
Opaganib, a Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia
Status:
Completed
Completed
Trial end date:
2021-07-18
2021-07-18
Target enrollment:
0
0
Participant gender:
All
All
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 opaganib to improve and/or stabilize the clinical status of the patient.Phase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
RedHill Biopharma Limited
Criteria
Inclusion Criteria:1. Adult male or female ≥18 to ≤80 years of age
2. 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
3. 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
4. Patient agrees to use appropriate methods of contraception during the study and 3
months after the last dose of study drug
5. The patient or legal representative has signed a written informed consent approved by
the IRB/Ethics Committee
Exclusion Criteria:
1. 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
2. Requiring intubation and mechanical ventilation at baseline
3. Patient has a 'Do Not Intubate' and/or 'Do Not Resuscitate' order in place
4. Oxygen saturation >95% on room air
5. Any preexisting respiratory condition that requires intermittent or continuous
ambulatory oxygen prior to hospitalization
6. Patient is, in the investigator's clinical judgement, unlikely to survive >72 hours
7. Pregnant (positive serum or urine test within 3 days prior to randomization) or
nursing women .
8. Unwillingness or inability to comply with procedures required in this protocol.
9. Corrected QT (QTc) interval on electrocardiogram (ECG) >470 ms for females or >450 ms
for males, calculated using Friedericia's formula (QTcF)
10. AST (SGOT) or ALT (SGPT) > 2.0 x upper limit of normal (ULN)
11. Total bilirubin >1.5x ULN (except where bilirubin increase is due to Gilbert's
Syndrome)
12. Serum creatinine >2.0 X ULN
13. Absolute neutrophil count <1000 cells/mm3
14. Platelet count <75,000/mm3
15. Hemoglobin <8.0 g/dL
16. 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
17. Moderate or strong inhibitors of CYP1A2, CYP3A4, CYP2D6 or P-gP or moderate to strong
inducers of CYP3A4 and CYP1A2 are prohibited
18. Currently taking warfarin, apixaban, argatroban or rivaroxaban due to drug-drug
interaction based on CYP450 metabolism
19. Current drug or alcohol abuse
20. Currently participating in a clinical study assessing pharmacological treatments,
including anti-viral studies
21. 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