Low Dose Oral Selinexor in Patients with Severe COVID-19 Infection [COVID-19]
Research type
Research Study
Full title
A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients with Severe COVID-19 Infection
IRAS ID
282398
Contact name
Piers Patten
Contact email
Sponsor organisation
Karyopharm Therapeutics Inc,
Eudract number
2020-001411-25
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
This is an early phase randomised, single-blind, placebo-controlled, multicentre study to investigate the activity and safety of low dose oral selinexor (KPT-330) in patients with severe COVID-19 infection. \nCOVID-19 is a disease characterized especially by fever, cough, and shortness of breath. In severe cases, it is accompanied by a marked inflammatory response and associated dysfunction, respiratory failure and death. It is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-Co-2).\nExportin 1 (XPO1) is a protein which has been implicated in viral propagation. Selinexor is an inhibitor of a nuclear export (SINE ) compound that specifically blocks XPO1. This mechanism may confer anti-vital and anti-inflammatory activity against the SARS-CoV2 virus. Selinexor is already available in a commercial supply of selinexor tablets because it received FDA accelerated approval in July 2019 for treatment of advanced multiple myeloma, in combination with dexamethasone. \nThis study aims to test the hypothesis that oral selinexor will expedite the recovery, suppress the viral load, shorten the hospitalization and reduce morbidity and mortality in patients with severe COVID-19 compared to standard of care.\nUp to 230 hospitalized adult subjects who are confirmed positive for SARS-CoV2 and have severe COVID-19 symptoms will take part. \nThe study drug (selinexor or placebo) will be administered on Days 1, 3, 5, 8, 10 and 12. If the subject is tolerating the therapy well and in the opinion of the treating physician is clinically benefitting, they may continue for an additional 2 weeks on Days 15, 17, 19, 22, 24 and 26. \nThe randomisation ratio of selinexor/placebo is 1:1. \nIf a subject is discharged from hospital during the study period, they will be followed up in outpatient clinics and by telephone.\nThe study will be conducted in approximately 40 international centres.\n\n
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0205
Date of REC Opinion
24 Apr 2020
REC opinion
Further Information Favourable Opinion