A Study of Opaganib in Coronavirus Disease 2019 Pneumonia

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    RedHill Biopharma Limited
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Updated on 16 February 2024
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x-rays
pneumonia
covid-19
chest x-ray
oropharyngeal
coronavirus infection
opaganib

Summary

Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and resulting pneumonia. This proof of concept study will take place in the US and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20 patients, will receive opaganib in addition to standard of care for 14 days. The other 20 will receive matching placebo (capsules that do not contain the medication) in addition to standard of care. Study drug will be administered every day for 14 days, twice each day, unless the patient has been discharged from the hospital without requiring supplemental oxygen, in which case study drug will only be administered for 10 days. All participants will be followed up for 4 weeks after their last dose of study drug.

Details
Condition Coronavirus Infection
Age 18years - 80years
Treatment Placebo, Opaganib
Clinical Study IdentifierNCT04414618
SponsorRedHill Biopharma Limited
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
The patient requires supplemental oxygen at baseline
The patient, guardian or legal representative has signed a written IRB-approved informed consent

Exclusion Criteria

Any co-morbidity that may add risk to the treatment in the judgement of the investigator
Requiring intubation and mechanical ventilation
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 judgment, unlikely to survive >72 hours
Pregnant 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) > 2.5 x upper limit of normal (ULN)
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
Currently taking medications that are sensitive CYP3A4, CYP2C9 or CYP2C19 substrates and have a narrow therapeutic index
Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4
Currently taking warfarin, apixaban, argatroban or rivaroxaban
Current drug or alcohol abuse
Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies
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