A Study of Opaganib in Coronavirus Disease 2019 Pneumonia
Condition: Coronavirus Infections
MeSH terms: Pneumonia; Coronavirus Infections
Intervention: Opaganib; Placebo
Intervention description: Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).; Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This proof of concept study will take place in the US and other countries in approximately 15
      clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19
      infection who have developed pneumonia and require supplemental oxygen. 20 patients will
      receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive
      matching placebo in addition to standard of care 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.
    

Eligibility 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

          3. The patient requires supplemental oxygen at baseline

          4. The patient, guardian or legal representative has signed a written IRB-approved
             informed consent.

        5) Male participants with female partners of child-bearing potential agree to one of the
        following methods of contraception during the treatment period and for at least 1 month
        after the last dose of study drug:

          -  Abstinence from penile-vaginal intercourse and agree to remain abstinent.

          -  Male condom, with female partner using a highly effective contraceptive method. (For
             further details regarding highly effective contraceptive methods please see section
             9.3.)

        In addition, male participants must refrain from donating sperm for the duration of the
        study and for 1 months after last dose of study drug.

        Male participants with a pregnant or breastfeeding partner must agree to remain abstinent
        from penile-vaginal intercourse or use a male condom during each episode of penile
        penetration for at least 1 months after the last dose of study drug

        Female participants:

        A female participant is eligible to participate if she is:

          1. not pregnant

          2. not breastfeeding

          3. not a woman of child-bearing potential (WOCBP, as defined in Section 9.3)

          4. a WOCBP who agrees to use a highly effective method of contraception consistently and
             correctly during the treatment period and for at least 1 months after the last dose of
             study drug (please see further details on Section 9.3).

        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. Patient having a do not intubate or do not resuscitate order

          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 judgment, unlikely to survive >72 hours

          7. Pregnant 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) > 2.5 x upper limit of normal (ULN)

         11. Bilirubin >2.0 x 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. Currently taking medications that are sensitive CYP3A4, CYP1A2, CYP2C9, or CYP2C19 or
             CYP2D6 substrates and have a narrow therapeutic index. These should be decided in
             discussion with the Medical Monitor on a case-by-case basis.

         17. Currently taking medications that are strong inducers or inhibitors of CYP2D6 and
             CYP3A4. These should be decided in discussion with the Medical Monitor on a
             case-by-case basis.

         18. Currently taking warfarin, apixaban, argatroban or rivaroxaban.

         19. Current drug or alcohol abuse.

         20. Currently participating in a clinical study assessing pharmacological treatments,
             including anti-viral studies.