A clinical trial using opaganib in adult patients hospitalised with severe pneumonia due to COVID-19

Phase 1

• Conditions: Severe SARS-CoV-2 Positive Pneumonia; MedDRA version: 20.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-002677-95-IT
• Lead Sponsor: RedHill Biopharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-10
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 270

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 or CT scan
3) The patient requires, at baseline, high flow supplemental oxygen or CPAP, if high oxygen flow is not an available option
4) Patient agrees to use appropriate methods of contraception during the study and 3 months after the last dose of study drug
5) The patient or legal representative has signed a written informed consent approved by the IRB/Ethics Committee
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 162

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) Oxygen saturation >95% on room air
4) Any preexisting respiratory condition that requires intermittent or continuous ambulatory oxygen prior to hospitalization
5) Patient is, in the investigator’s clinical judgement, unlikely to survive >72 hours
6) Pregnant (positive serum or urine test within 3 days prior to randomization) or nursing women
7) Unwillingness or inability to comply with procedures required in this protocol.
8) Corrected QT (QTc) interval on electrocardiogram (ECG) >470 ms for females or >450 ms for males, calculated using Friedericia’s formula (QTcF)
9) AST (SGOT) or ALT (SGPT) > 2.5 x upper limit of normal (ULN)
10) Total bilirubin >1.5x ULN (except where bilirubin increase is due to Gilbert’s Syndrome)
11) Serum creatinine >2.0 X ULN
12) Absolute neutrophil count <1000 cells/mm3
13) Platelet count <75,000/mm3
14) Hemoglobin <8.0 g/dL
15) Currently taking medications that are sensitive CYP3A4, CYP2C9 or CYP2C19 substrates and have a narrow therapeutic index
16) Currently taking medications that are strong inducers or inhibitors of CYP2D6 and CYP3A4
17) Currently taking warfarin, apixaban, argatroban or rivaroxaban due to drug-drug interaction based on CYP450 metabolism
18) Current drug or alcohol abuse
19) Currently participating in a clinical study assessing pharmacological treatments, including anti-viral studies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified