Clinical trial NCT04502069: Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen
Official title: Treatment of COVID-19 With Opaganib in Patients With Pneumonia Requiring Oxygen But Not Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: COVID-19
Lung Infection
Keywords: Therapeutic Use
Lead sponsor: RedHill Biopharma Limited
Sponsor class: INDUSTRY
First posted: 2020-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients diagnosed with COVID-19 infection will be offered treatment with Opaganib, 500 mg Q12 hours. Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks).

Detailed description: Patients diagnosed with COVID-19 infection by nasopharyngeal viral swab, classified as severe disease, category 5, by the WHO Ordinal Scale For Clinical Improvement (who require oxygen support by high flow nasal cannula but do not require mechanical ventilation) at the time of initiation of therapy will be offered treatment with Opaganib, 500 mg Q12 hours.

Opaganib will be continuously administered for up to 2 weeks, until discharged on room air (if earlier than 2 weeks), upon voluntary withdrawal is initiated by the patient or when the physician decides that it is not in the patient's best interest to continue.

Eligibility criteria: Inclusion Criteria:

1. Patients with proven COVID-19 infection diagnosed by nasopharyngeal viral swab who require external oxygen support by high flow nasal cannulas (HFNC) but not mechanical ventilation.
2. Pneumonia documented by chest x-ray (CXR)
3. The patient or guardian must have signed a written IRB-approved informed consent.
4. A negative pregnancy test (if woman of childbearing potential).
5. Acceptable liver and renal function:

   1. Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 2 baseline)
   2. AST (SGOT), ALT (SGPT) ≤ 3.0 x upper limit of normal (ULN),
   3. Serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
6. Acceptable hematologic status:

   1. Absolute neutrophil count ≥1000 cells/mm3
   2. Platelet count ≥75,000 (plt/mm3) (CTCAE Grade 1 baseline)
   3. Hemoglobin ≥ 9 g/dL
7. Clinically acceptable blood sugar control if diabetic
8. EKG showing no QTc prolongation

Exclusion Criteria:

1. Any co-morbidity that that is considered by the treating investigator as an unacceptable risk
2. Pregnant or nursing women
3. Unwillingness or inability to comply with procedures required in this protocol.
4. Caution must be exercised in patients who are receiving drugs that were sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped or replaced with another appropriate medication or not given for the duration of the clinical study. These patients must be discussed with the sponsor in order to determine appropriateness for opaganib therapy.
5. Patients who are taking warfarin, apixaban, argatroban or rivaroxaban
6. Patients with QTc prolongation

Primary outcomes:
measure: Time to breathing room air
timeFrame: Up to 2 weeks
measure: Adverse Event Grading and Coding
timeFrame: Up to 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: RedHill Biopharma Limited
name: Mark L Levitt, MD
role: STUDY_DIRECTOR
References: