Phase 2
Completed N=42
A Study of Opaganib in Coronavirus Disease 2019 Pneumonia
Coronavirus Infections
Source: ClinicalTrials.gov NCT04414618 ↗
Enrolled (actual)
42
Serious AEs
19.5%
Results posted
Mar 2022
Primary outcomePrimary: Measurement of the Change in Oxygen Requirement From Baseline — -38.8; -33.0 L/min*day
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of the Change in Oxygen Requirement From Baseline |
-38.8; -33.0 | — |
| SECONDARY Measurement of Time to the Reduction in Oxygen Requirement. |
5.00; 8.00 | — |
| SECONDARY The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14 |
11; 4 | — |
| SECONDARY Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment |
NA; NA | — |
| SECONDARY The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14 |
NA; NA | — |
| SECONDARY Intubation and Mechanical Ventilation Requirements |
2; 2 | — |
| SECONDARY Evaluation of the Time to Intubation and Mechanical Ventilation |
NA; NA | — |
| SECONDARY Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14 |
3; 0 | — |
| SECONDARY Evaluation of Mortality 30 Days Post-baseline |
3; 2 | — |
Eligibility Criteria
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.
- 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:
- not pregnant
- not breastfeeding
- not a woman of child-bearing potential (WOCBP, as defined in Section 9.3)
- 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
- Any co-morbidity that may add risk to the treatment in the judgement of the investigator.
- Requiring intubation and mechanical ventilation
- Patient having a do not intubate or do not resuscitate order
- 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 >2.0 x 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, 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.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04414618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.