Severe SARS-CoV-2 Positive Pneumonia MedDRA version: 20.0 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Opaganib
Product Code: [ABC294640]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Opaganib
Current Sponsor code: ABC294640
Concentration unit: mg milligram(s)
Concentration type
Sponsors
RedHill Biopharma Limited
Eligibility
Sex/Gender
All
Inclusion 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 3) The patient requires, at baseline, high flow supplemental oxygen or CPAP, if high oxygen flow is not an available option 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 162
Exclusion criteria
Exclusion criteria: 1) Any co-morbidity that may add risk to the treatment in the judgement of the investigator. 2) Requiring intubation and mechanical ventilation 3) Oxygen saturation >95% on room air 4) Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization 5) Patient is, in the investigator’s clinical judgement, unlikely to survive >72 hours 6) Pregnant (positive serum or urine test within 3 days prior to randomization) or nursing women 7) Unwillingness or inability to comply with procedures required in this protocol. 8) Corrected QT (QTc) interval on electrocardiogram (ECG) >470 ms for females or >450 ms for males, calculated using Friedericia’s formula (QTcF) 9) AST (SGOT) or ALT (SGPT) > 2.5 x upper limit of normal (ULN) 10) Total bilirubin >1.5x ULN (except where bilirubin increase is due to Gilbert’s Syndrome) 11) Serum creatinine >2.0 X ULN 12) Absolute neutrophil count <1000 cells/mm3 13) Platelet count <75,000/mm3 14) Hemoglobin <8.0 g/dL 15) Currently taking medications that are sensitive CYP3A4, CYP2C9 or CYP2C19 substrates and have a narrow therapeutic index 16) Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4 17) Currently taking warfarin, apixaban, argatroban or rivaroxaban due to drug-drug interaction based on CYP450 metabolism 18) Current drug or alcohol abuse 19) Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The percentage of patients with =2 category improvement on the WHO Ordinal Scale for Clinical Improvement 2) The time to intubation and mechanical ventilation 3) The time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option 4) The percentage of patients no longer receiving supplemental oxygen for at least 24 hours by Day 14 5) The total oxygen requirement (area under the curve) using the daily supplemental oxygen flow (L/min) over 14 days (Day 1 to Day 14) 6) The time to two consecutive negative swabs for SARS-CoV-2 by PCR, at least 24 hours apart 7) The percentage of patients with at least two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 8) The percentage of patients with at least one measurement of fever at baseline (defined as temperature >38.0 C[100.4 F]), who are afebrile (defined as temperature <37.2C [99 F]) at Day 14 9) Mortality due to any cause at Day 30 after baseline;Timepoint(s) of evaluation of this end point: The following reflects the timepoints for the secondary endpoints listed above: 1) Day 1, 7 and 14 2) Day 1 to Day 14 3) Day 1 to Day 14 4) Day 14 5) Day 1 to Day 14 6) Day 1 to Day 14 7) Day 14 8) Day 14 9) Day 30 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the proportion of patients requiring intubation and mechanical ventilation by Day 14;Secondary Objective: To evaluate: 1) change on the WHO Ordinal Scale for Clinical Improvement 2) the time to intubation and mechanical ventilation 3) the time to low oxygen flow via nasal cannula e.g. from high oxygen flow via nasal cannula or CPAP, if high oxygen flow is not an available option 4) the proportion of patients no longer requiring supplemental oxygen for at least 24 hours by Day 14 5) the total oxygen requirement (area under the curve) using daily supplemental oxygen flow (L/min) over 14 days (Day 1 to Day 14) 6) the time to two consecutive negative swabs for SARS-CoV-2 by PCR 7) the proportion of patients with two consecutive negative swabs for SARS-CoV-2 by PCR at Day 14 8) the proportion of patients, with at least one measurement of fever at baseline (defined as temperature >38.0°C [100.4°F]), who are afebrile (defined as temperature <37.2°C [99°F]) at Day 14 9) mortality 30 days post-baseline;Primary end point(s): The percentage of patients requiring intubation and mechanical ventilation by Day 14;Timepoint(s) of evaluation of this end point: Day 14 | — |
Countries
Brazil, Italy, Mexico, Russian Federation, United Kingdom, United States
Contacts
Public ContactABC-201 Study Information
RedHill Biopharma Ltd.
Outcome results
None listed