COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04467840

Mark Levitt, MD

info@redhillbio.com

2020-07-13

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

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 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

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

2

RedHill Biopharma Limited

18

80

Brazil;Colombia;Israel;Italy;Mexico;Peru;Poland;Russia;United Kingdom;United States

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

475

Supplemental oxygen requirement

None

Phase 2/Phase 3

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