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.
Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and resulting pneumonia. This proof of concept study will take place in the US and other countries and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20 patients, will receive opaganib in addition to standard of care for 14 days. The other 20 will receive matching placebo (capsules that do not contain the medication) in addition to standard of care. Study drug will be administered every day for 14 days, twice each day, 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
42
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).
HonorHealth Research Institute
Scottsdale, Arizona, United States
Miami Cancer Institute
Miami, Florida, United States
Henry Ford Hospital
Detroit, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Albany Medical Center
Albany, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Memorial Herman Southeast Hospital
Houston, Texas, United States
Memorial Hermann, Memorial City Medical Center
Houston, Texas, United States
Ziv Medical Center
Safed, Israel
Measurement of the Change in Oxygen Requirement From Baseline
Maximal oxygen flow (L/min) was recorded daily for the 14 days of treatment for each participant. Participant individual area under the curve (AUC) was calculated based on the trapezoidal rule, after subtracting the baseline oxygen requirement at each day. The median AUC absolute change from baseline (L/min) for each treatment arm is presented.
Time frame: 14 days
Measurement of Time to the Reduction in Oxygen Requirement.
The time required between arms to achieve 50% reduction from baseline in supplemental oxygen based on oxygen flow in L/min.
Time frame: 14 days
The Percentage of Subjects no Longer Receiving Supplemental Oxygen for at Least 24 Hours by Day 14
The percentage of subjects in each arm no longer requiring supplemental oxygen for at least 24 hours by Day 14.
Time frame: 14 days
Time to Negative Swabs for SARS-CoV-2 by PCR Post Treatment
The time in each arm to two consecutive negative swabs for SARS-CoV-2 by PCR nasopharyngeal or oropharyngeal swab, at least 24 hrs. apart.
Time frame: 6 weeks
The Percentage of Subjects With at Least Two Consecutive Negative Swabs for SARS-CoV-2 by PCR at Day 14
The percentage of subjects in each arm to achieve two consecutive negative PCR nasopharyngeal or oropharyngeal swabs for SARS-CoV-2 at Day 14, at least 24 hrs. apart.
Time frame: 14 days
Intubation and Mechanical Ventilation Requirements
The percentage of patients in each arm who require intubation and mechanical ventilation by Day 14
Time frame: From screening phase and every day from day 1 to day 14 of treatment
Evaluation of the Time to Intubation and Mechanical Ventilation
The time in each arm for the patient to require mechanical ventilation.
Time frame: From screening phase and every day from day 1 to day 14 of treatment
Evaluation the Proportion of Patients, With at Least One Measurement of Fever at Baseline Who Are Afebrile at Day 14
The proportion of patients in each arm, 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
Time frame: From screening phase and every day from day 1 to day 14 of treatment
Evaluation of Mortality 30 Days Post-baseline
The mortality in each arm 30 days post-baseline.
Time frame: 30 days after day 1 of treatment
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