None listed
Conditions
Interventions
GROUP 1 Type of group
Opaganib 500 mg Every 12 hours as a suspension, can be administered by nasogastric tube.
Group name:group 2 Type of group
placebo (opaganid) 500 mg Every 12 hours as a suspension, can be administered by nasogastric tube.
Sponsors
RedHill Biopharma Ltd.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult men or women ≥18 to ≤80 years 2. Infection proven by COVID-19 by RT-PCR assay of a pharyngeal specimen (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest x-ray or CT that diagnosed COVID-19 pneumonia. Pharyngeal specimens collected at screening or within 7 days prior to screening are acceptable for the same ongoing COVID-19 pneumonia disease. 3. Patient requires, at baseline, supplemental high-flow oxygen or positive pressure ventilation, if high-flow oxygen is not an available option. 4. Male participants with female partners of childbearing potential accept one of the following appropriate contraceptive methods during the treatment period and for at least 1 month after the last dose of study drug: Abstinence from penile-vaginal intercourse and agreeing to remain abstinent. • Male condom, with the female partner using a highly effective contraceptive method. (For more details on highly effective contraceptive methods, see Section 11.3). Additionally, male participants must refrain from donating sperm during the study and for 1 month after the last dose of study drug. Male participants with a pregnant or lactating partner must agree to abstain from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 month after the last dose of the penile drug. study. Female participants: A participant is eligible to participate if: a) is not pregnant b) not breastfeeding c) is not a woman of childbearing age (WOCBP, as defined in Section 11.3) d) is a WOCBP who agrees to consistently and correctly use a highly effective method of contraception during the treatment period and for at least 1 month after the last dose of study drug (see Section 11.3 for details). 5. The patient or legal representative has signed a written informed consent approved by the Ethics Committee / IRB
Exclusion criteria
Exclusion criteria: 1. Any comorbidity that may add risk to the treatment in the judgment of the investigator 2. Require intubation and mechanical ventilation in the baseline period 3. Patient has a Do not intubate and / or Do not resuscitate order present. 4. Oxygen saturation> 95% in ambient air 5. Any pre-existing respiratory condition requiring intermittent or continuous ambulatory oxygen prior to hospitalization. 6. If it is unlikely, based on the investigator´s clinical judgment, that the patient will survive> 72 hours 7. Pregnant women (positive urine or serum test within 3 days prior to randomization) or lactating women 8. Lack of will or inability to comply with the procedures required in this protocol 9. Corrected QT interval (QTc) on the electrocardiogram (ECG)> 470 ms for women or> 450 ms for men, calculated using Friedericia´s formula (QTcF) 10. AST (SGOT) or ALT (SGPT)> 5.0 x upper limit of normal (ULN) 11. Total bilirubin> 2.0 x ULN (except where increased bilirubin is due to Gilbert Syndrome) 12. Serum creatinine> 2.0 X ULN 13. Absolute neutrophil count <1000 cells / mm3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical/laboratory Measure:the proportion of patients requiring intubation and mechanical ventilation Timepoints:by Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:WHO Ordinal Scale for Clinical Improvement Measure:Percentage of patients with clinical improvement category ≥2 Timepoints:by Day 14 ; Outcome name:WHO Ordinal Scale for Clinical Improvement Measure:Time to category improvement ≥2 on the clinical scale Timepoints:by Day 14 ; Outcome name:WHO Ordinal Scale for Clinical Improvement Measure:Recovery time improvement to a score of 0 or 1 Timepoints:by Day 14 ; Outcome name:Clinical/laboratory Measure:Time to intubation and mechanical ventilation Timepoints:by Day 14 ; Outcome name:Clinical/laboratory Measure:Time to reduce the flow of oxygen through the nasal cannula Timepoints:by Day 14 ; Outcome name:Clinical/laboratory Measure:Percentage of patients no longer receiving supplemental oxygen for Timepoints:by Day 14 | — |
Countries
Brazil, Israel, Mexico, Peru, Russian Federation
Contacts
Public ContactRaul Florentino Hernan Yepez
PERUVIAN CLINICAL RESEARCH S.A.C
Outcome results
None listed