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
Latest Information Update: 23 Jan 2023
At a glance
- Drugs Selinexor (Primary)
- Indications COVID-19 respiratory infection
- Focus Therapeutic Use
- Sponsors Karyopharm Therapeutics
- 23 Dec 2020 Status changed from discontinued to completed.
- 06 Oct 2020 Results presented in a Karyopharm Therapeutics Media Release.
- 06 Oct 2020 According to a Karyopharm Therapeutics media release, data will be presented at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group (ISIRV-AVG) Virtual Conference on Therapeutics for COVID-19.
Most Recent Events
Trial Overview
Purpose
The main purpose of this study is to evaluate the activity of low dose oral selinexor (KPT-330) and to evaluate the clinical recovery, the viral load, length of hospitalization and the rate of morbidity and mortality in participants with severe COVID-19 compared to placebo.
Comments
According to a Karyopharm Therapeutics media release, the Data Safety Monitoring Board (DSMB) has recommended to discontinue this trial following a planned interim analysis (115 patients included in the efficacy analysis and 113 patients included in the safety analysis) as the trial is unlikely to demonstrate a statistically significant efficacy benefit across the entire heterogenous patient population studied.
Primary Endpoints
Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale
description: Ordinal Scale 2-Point improvement was defined as percentage of participants with at least a 2-points improvement (increase from baseline) by Day 14. Baseline score was defined as the last score measured before first dosing. The 8-point ordinal scale ranges from 1 to 8: where 1= death, 2= hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus disease 2019 [COVID-19] related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
time_frame: Baseline up to Day 14
Absence of fever: oral temperature <38C x 24 hours without antipyretics (acetaminophen) AND one of the following
− Respiratory rate < or =24/minute OR
− Oxygen saturation > or = 94% on room air OR
− Hospital discharge
Timepoint(s) of evaluation of this end point: Throughout the study
Other Endpoints
Percentage of Participants With at Least a 2-Point Improvement in the Ordinal Scale up to Day 7
description: Ordinal Scale 2-points improvement was defined as percentage of participants with at least a 2-points improvement (increase from baseline) by Day 7. Baseline score was defined as the last score measured before first dosing. The 8-point ordinal scale ranges from 1 to 8: where, 1= death, 2= hospitalized, on invasive mechanical ventilation or ECMO; 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
time_frame: Baseline up to Day 7
Percentage of Participants With at Least a 1-Point Improvement in the Ordinal Scale
description: Ordinal Scale 1-point improvement was defined as percentage of participants with at least 1-point improvement (increase from baseline) by Day 7 and 14. Baseline score was defined as the last score measured before first dosing. The 8-point ordinal scale ranges from 1 to 8: where 1= death, 2= hospitalized, on invasive mechanical ventilation or ECMO; 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
time_frame: Baseline up to Day 7 and 14
Time to Clinical Improvement of 2-points Using Ordinal Scale (TTCI-2)
description: TTCI-2 was defined as the time from randomization to an improvement of 2-points using 8-points Ordinal Scale. The 8-point ordinal scale ranges from 1 to 8: where 1= death, 2= hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3= hospitalized, on non-invasive ventilation or high flow oxygen devices; 4= hospitalized, requiring supplemental oxygen; 5= hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus disease 2019 [COVID-19] related or otherwise); 6= hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7= not hospitalized, limitation on activities and/or requiring home oxygen; 8= not hospitalized, no limitations on activities.
time_frame: Baseline up to Day 28
Overall Death Rate
description: Overall death rate was defined as the percentage of participants who died on or before Day 28.
time_frame: Baseline up to Day 28
Rate of Mechanical Ventilation (RMV)
description: The rate of RMV was defined as the percentage of participants who ever used invasive mechanical ventilation or ECMO during the hospital stay.
time_frame: Baseline up to Day 28
Rate of Intensive Care Unit (ICU) Admission
description: The rate of ICU admission was defined as the percentage of participants with ICU admissions.
time_frame: Baseline up to Day 28
Length of Hospitalization
description: Length of hospitalization (days) was defined as (first hospital discharge date - date of randomization + 1).
time_frame: Baseline up to Day 67
Change From Baseline in C-reactive Protein (CRP) Levels
description: The anti-inflammatory and immune effects of selinexor were assessed by CRP levels. Baseline was defined as the most recent non-missing measurement prior to the first administration of study treatment. Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
time_frame: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Change From Baseline in Ferritin Levels
description: The anti-inflammatory and immune effects of selinexor were assessed by ferritin levels. Baseline was defined as the most recent non-missing measurement prior to the first administration of study treatment. Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
time_frame: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Change From Baseline in Lactate Dehydrogenase (LDH) Levels
description: The anti-inflammatory and immune effects of selinexor were assessed by LDH levels. Baseline was defined as the most recent non-missing measurement prior to the first administration of study treatment. Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
time_frame: Baseline, Day 3, 5, 8, 12, 15, 19, 22 and 26
Changes From Baseline in Blood Plasma Cytokines Levels-Interleukin-6 (IL-6)
description: The anti-inflammatory and immune effects of selinexor were assessed by blood plasma cytokines like IL-6. Baseline was defined as the most recent non-missing measurement prior to the first administration of study treatment. Change from Baseline at the indicated time points was calculated as the value at the indicated time points minus the value at Baseline.
time_frame: Baseline, Day 3, 5, 8, 12, 15, 22 and 26
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
description: Adverse events are defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are defined as those AEs that develop or worsen after the first dose of study drug. TEAEs included both Serious and non-serious TEAEs.
time_frame: From start of study drug administration up to Day 58 [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID-19 respiratory infection | treatment | severe |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04349098 | C-reactive protein (CRP) | Eligibility Criteria, Outcome Measure |
| Ferritin | Outcome Measure | |
| Interleukin-6 (IL-6) | Outcome Measure |
Subjects
- Subject Type patients
-
Number
Planned: 300
Actual: 190
- Sex male & female
- Age Group ≥18 years; adult; elderly
Patient Inclusion Criteria
- Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent FDA-approved testing (local labs). - Currently hospitalized. - Informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent). - Has symptoms of severe COVID-19 as demonstrated by: - At least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms of severe lower respiratory symptoms including dyspnea at rest or respiratory distress. - Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: SaO2 <92% on room air in last 12 hours or requires > 4 liters per minute (LPM) oxygen by nasal canula, non-rebreather/Ventimask or high flow nasal canula in order maintain SaO2 ≥92%, PaO2/FiO2 <300 millimeter per mercury (mm/hg). - Elevated C-reactive protein (CRP) > 2 x upper limit of normal (ULN). - Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. If in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form. - Female participants of childbearing potential must have a negative serum pregnancy test at Screening. Female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
Patient Exclusion Criteria
- Evidence of critical COVID-19 based on: - Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations) - Septic shock (defined by Systolic blood pressure [BP] < 90 mm Hg, or Diastolic BP < 60 mm Hg) - Multiple organ dysfunction/failure - In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours. - Inadequate hematologic parameters as indicated by the following labs: - Participants with severe neutropenia (ANC <1000 x 10^9/L) or - Thrombocytopenia (e.g., platelets <100,000 per microliter of blood) - Inadequate renal and liver function as indicated by the following labs: - Creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault - Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 x ULN - Hyponatremia defined as sodium < 135 milliequivalents per liter (mEq/L). - Unable to take oral medication when informed consent is obtained. - Participants with a legal guardian or who are incarcerated. - Treatment with strong CYP3A inhibitors or inducers. - Pregnant and breastfeeding women.
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04349098 | ClinicalTrials.gov: US National Institutes of Health |
| EudraCT2020-001411-25 | European Clinical Trials Database |
| XPORT-CoV1001 | - |
Organisations
- Sponsors Karyopharm Therapeutics
- Affiliations Karyopharm Therapeutics
Trial Dates
-
Initiation Dates
Planned : 30 Apr 2020
Actual : 17 Apr 2020
-
Primary Completion Dates
Planned : 31 Aug 2020
Actual : 05 Oct 2020
-
End Dates
Planned : 31 Aug 2020
Actual : 05 Oct 2020
Other Details
- Design multicentre; parallel; prospective; randomised; single-blind
- Phase of Trial Phase II
- Location Australia; Austria; Belgium; Canada; England; France; Germany; India; Israel; Italy; Malaysia; Spain; United Kingdom; USA
- Focus Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| SelinexorPrimary Drug | Oral | Tablet |
Selinexor 20 mg
Participants will receive 20 milligram (mg) of selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days).
Drug: Selinexor (Participants will receive 20 mg of selinexor.) Other Name: KPT-330, XPOVIO
Placebo
Participants will receive 20 mg of placebo matched to selinexor oral tablet on Days 1, 3, and 5 of each week for up to 2 weeks (14 days). If the participant is tolerating therapy and clinically benefitting, dosing can continue for an additional 2 weeks (28 days).
Other: Placebo (Participants will receive 20 mg of placebo matched to selinexor.)
Results
Therapeutic efficacy
COVID-19 infection:
Phase II: In post hoc analysis indicated treatment with selinexor (n=38) compared to placebo (n=28) was associated with a significantly higher percentage of patients discharged by Day 14 (78.9% vs 57.1%; p=0.029) in 66 patients with either baseline serum lactate dehydrogenase (LDH) = 370 U/L or D-dimer = 600mcg/L FEU (Low LDH/DD). On day 14, the trend was observed to be superior =2-point improvement in the Ordinal Scale (OSI-2) (78.9% vs 64.3%; p=0.095). Compared to placebo, patients treated with the drug indicated a postive trend to convert to a negative COVID-19 PCR test (42.1% vs 28.6%; p=0.13). Within eight days of the treatment reduction in TNF-a levels, IL1-RA, IL-6, IL-7, IP-10 and measurements of inflammation was reported (p<0.05). In phase II study, 115 evaluable patients with COVID-19 infection met its primary endpoint indicating improvement in Ordinal Score at Day 14 and the rate of hospital discharge by Day 14 (all p=0.05).There was also a significant improvement in conversion to SARS-CoV2 PCR negative status on the selinexor arm as compared with the placebo arm across the entire population (p=0.05). There was no improvement seen in the clinical outcomes of patients of age 75 years old or with a COVID-GRAM high risk score; fatalities were higher in the selinexor arm (6/15) than the placebo arm (1/12). The rate of fatalities were high due to severe COVID-19 disease and/or underlying comorbidities without a clear contribution of selinexor [2] .
Adverse events
Adverse events data obtained from the phase II trial indicated 51.9% of patients with placebo compared to 63.2% of treated patients with adverse events. Similar occurrences of deaths were observed across the treatment arms (2 vs 1) [2] .
Publications
-
Karyopharm Therapeutics. Karyopharm Announces Selinexor Clinical Data to be Presented at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group Virtual Conference on Therapeutics for COVID-19. Media-Rel 2020;.
Media Release -
Karyopharm Therapeutics. Karyopharm Reports Second Quarter 2020 Financial Results and Highlights Recent Company Progress. Media-Rel 2020;.
Media Release
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
| Arnaud Desclaux | CHU Bordeaux | France |
| Benito Almirante | Hospital Universitari Vall d'Hebron | Spain |
| Catherine Small | Weill Cornell Medical College | USA |
| Charles Hare | Kaiser Permanente San Francisco | USA |
| Don Stevens | Norton Healthcare | USA |
| Dror Diker | Hasharon Medical Center | Israel |
| Enrico Lallana | Kaiser Permanente Sacramento | USA |
| Florent Valor | CHU Lyon | France |
| Francois Raffi | CHU Nantes | France |
| Gennatas Spyridon | The Royal Marsden Hospital | United-Kingdom |
| George Lyon | Emory University | USA |
| George Thompson | UC Davis Health | USA |
| Guenther Koehne | Miami Cancer Institute at Baptist Health | USA |
| Itzchak Levy | Sheba Medical Center | Israel |
| Jacek Skarbinksi | Kaiser Permanente Oakland | USA |
|
Jatin Shah, Chief Medical Officer
(617) 658-0600
show details
jshah@karyopharm.com |
Karyopharm Therapeutics |
-
|
| Jeff Zonder | Karmanos | USA |
| Khalid Rao | Michigan Center of Medical Research | USA |
| Kurt Redlich | Hospital Hietzing, 2. Medical department - Center for Diagnosis and Therapy of Rheumatic Diseases | Austria |
| Mansour Ceesay | Princess Royal University Hospital | United-Kingdom |
| Marcelo Gareca | Lehigh Valley Hospital | USA |
| Matthew Cramp | University Hospitals Plymouth NHS Trust | United-Kingdom |
| Matthew Ingham | Columbia University | USA |
| Mezgebe Berhe | Baylor Scott & White Dallas |
-
|
| Miguel Marcos Martin | Servicio de Medicina Interna, Hospital Universitario de Salamanca, Universidad de Salamanca | Spain |
| Nathan Bahr | University of Kansas Medical Center | USA |
| Otto Yang | UCLA | USA |
| Piers Patten | Kings College Hospital | United-Kingdom |
| Ran Nir-Paz | Hadassah MC | Israel |
| Ronda Oram | Advocate Christ Medical Center | USA |
|
Sharon Shacham, President and CSO
(617) 658-0600
show details
sshacham@karyopharm.com |
Karyopharm Therapeutics |
-
|
| Steven Katzman | Michigan Center of Medical Research | USA |
| Vaishali Sanchorawala | Boston Medical Center | USA |
| Vinay Malhotra | MultiCare Institute for Research & Innovation (Puget Sound) |
-
|
| Zainab Shahid | Levine Cancer Institute-Atrium Health University City | USA |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| Advocate Christ Medical Center | Oak Lawn, Illinois | USA |
| Baylor Scott & White Dallas | Dallas, Texas | USA |
| Boston Medical Center | Boston, Massachusetts | USA |
| CHU Bordeaux | Bordeaux | France |
| CHU Lyon | Lyon | France |
| CHU Nantes | Nantes | France |
| Columbia University | New York, New York | USA |
| Emory University | Atlanta, Georgia | USA |
| Hadassah MC | Jerusalem | Israel |
| Hasharon Medical Center | Petah Tiqva | Israel |
| Hospital Hietzing, 2. Medical department - Center for Diagnosis and Therapy of Rheumatic Diseases | Vienna | Austria |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| Kaiser Permanente Oakland | Oakland, California | USA |
| Kaiser Permanente Sacramento | Sacramento, California | USA |
| Kaiser Permanente San Francisco | San Francisco, California | USA |
| Karmanos | Detroit, Michigan | USA |
| Karyopharm Therapeutics |
-
|
-
|
|
Karyopharm Therapeutics Inc.
Clinical Trial Information Desk
show details
Street Address 85 Wells Ave Town/ city Newton Post code MA 02459 Country United States Telephone number +34923 291 100 clinicaltrials@karyopharm.com |
Newton, Massachusetts | USA |
| Kings College Hospital | London | United-Kingdom |
| Lehigh Valley Hospital | Allentown, Pennsylvania | USA |
| Levine Cancer Institute-Atrium Health University City | Charlotte, North Carolina | USA |
| Miami Cancer Institute at Baptist Health | Miami, Florida | USA |
| Michigan Center of Medical Research | Farmington Hills, Michigan | USA |
| Michigan Center of Medical Research | Royal Oak, Michigan | USA |
| MultiCare Institute for Research & Innovation (Puget Sound) | Tacoma, Washington | USA |
| Norton Healthcare | Louisville, Kentucky | USA |
| Princess Royal University Hospital | Kent | United-Kingdom |
| Servicio de Medicina Interna, Hospital Universitario de Salamanca, Universidad de Salamanca | Salamanca | Spain |
| Sheba Medical Center | Tel HaShomer | Israel |
| The Royal Marsden Hospital | London | United-Kingdom |
| UC Davis Health | Sacramento, California | USA |
| UCLA | Los Angeles, California | USA |
| University Hospitals Plymouth NHS Trust | Plymouth | United-Kingdom |
| University of Kansas Medical Center | Kansas City, Kansas | USA |
| Weill Cornell Medical College | New York, New York | USA |
Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 23 Jan 2023 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 23 Jan 2023 |
| 01 Nov 2021 | Biomarker Update | Biomarkers information updated Updated 03 Nov 2021 |
| 04 May 2021 | Other trial event | Last checked against European Clinical Trials Database record. Updated 04 May 2021 |
| 23 Dec 2020 | Status change - completed | Status changed from discontinued to completed. Updated 29 Dec 2020 |
| 06 Oct 2020 | Results | Results presented in a Karyopharm Therapeutics Media Release. Updated 09 Oct 2020 |
| 06 Oct 2020 | Other trial event | According to a Karyopharm Therapeutics media release, data will be presented at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group (ISIRV-AVG) Virtual Conference on Therapeutics for COVID-19. Updated 09 Oct 2020 |
| 04 Aug 2020 | Interim results | Results published in the Karyopharm Therapeutics financial media release. Updated 06 Aug 2020 |
| 04 Aug 2020 | Other trial event | According to a Karyopharm Therapeutics media release, the protocol was amended to allow enrollment of patients with more severe disease in May 2020. Updated 06 Aug 2020 |
| 04 Aug 2020 | Other trial event | According to a Karyopharm Therapeutics media release, will continue to analyze the data to further characterize the specific subpopulation that will likely benefit from selinexor and will work with the FDA to identify a path forward for future clinical development and seek potential partners and external funding to advance future clinical studies. Updated 06 Aug 2020 |
| 04 Aug 2020 | Other trial event | According to a Karyopharm Therapeutics media release, the Data Safety Monitoring Board (DSMB) has recommended to discontinue this trial following a planned interim analysis (115 patients included in the efficacy analysis and 113 patients included in the safety analysis) as the trial is unlikely to demonstrate a statistically significant efficacy benefit across the entire heterogenous patient population studied. Updated 06 Aug 2020 |
| 04 Aug 2020 | Status change - discontinued | Status changed from recruiting to discontinued, according to a Karyopharm Therapeutics media release. Updated 06 Aug 2020 |
| 16 Jul 2020 | Other trial event | This trial has been discontinued in Austria, as per European Clinical Trials Database record. Updated 16 Jul 2020 |
| 10 Jul 2020 | Other trial event | This trial has been suspended in Spain, as per European Clinical Trials Database record. Updated 10 Jul 2020 |
| 10 Jul 2020 | Other trial event | This trial has been discontinued in Germany, as per European Clinical Trials Database record. Updated 10 Jul 2020 |
| 24 May 2020 | Other trial event | Planned number of patients changed from 230 to 300. Updated 26 May 2020 |
| 30 Apr 2020 | Other trial event | According to a PROMETRIKA and Karyopharm Therapeutics media release, this study will be conducted in collaboration of the PROMETRIKA. Updated 05 May 2020 |
| 22 Apr 2020 | Other trial event | According to a Precision for Medicine media release, Precision will be responsible for ensuring site engagement, obtaining regulatory and clinical governing authority approvals, documentation preparation, as well as collecting and monitoring data. Updated 22 Apr 2020 |
| 22 Apr 2020 | Other trial event | According to a Precision for Medicine media release, Precision for Medicine is collaborating with Karyopharm Therapeutics to help conduct this first global randomized clinical trial for low dose selinexor in hospitalized patients with severe COVID-19.Precision for Medicine will oversee implementation of the clinical trial in Europe. The countries planning to participate in the study and where sites will be located include the United Kingdom, Italy, France, Spain, Germany, and Austria. Updated 22 Apr 2020 |
| 21 Apr 2020 | Other trial event | New source identified and integrated (European Clinical Trials Database EudraCT2020-001411-25). Updated 21 Apr 2020 |
| 20 Apr 2020 | Other trial event | According to a Karyopharm Therapeutics media release, first patient has been dosed. Updated 22 Apr 2020 |
| 20 Apr 2020 | Other trial event | New source identified and integrated(ClinicalTrials.gov: US National Institutes of Health;NCT04349098). Updated 20 Apr 2020 |
| 19 Apr 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 22 Apr 2020 |
| 14 Apr 2020 | Other trial event | Status changed from planning to not yet recruiting. Updated 21 Apr 2020 |
| 08 Apr 2020 | Other trial event | According to a Karyopharm Therapeutics media release, Komodo Health announced a collaboration with Karyopharm Therapeutics to accelerate clinical trial recruitment and site identification in an effort to speed patient access to a potential new treatment for COVID-19. Within hours of determining the project scope and appropriate patient cohort, Komodos Healthcare Map provided a snapshot of virology and infectious disease patterns to inform trial site identification. Updated 13 Apr 2020 |
| 08 Apr 2020 | New trial record | New trial record Updated 08 Apr 2020 |
| 07 Apr 2020 | Other trial event | According to a Karyopharm media release, the company plans to initiate a global randomized clinical trial for low dose oral selinexor in hospitalized patients with severe COVID-19. Selinexor, marketed as XPOVIO, is currently approved at higher doses by the Food and Drug Administration (FDA) as a treatment for patients with relapsed or refractory multiple myeloma Updated 08 Apr 2020 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Karyopharm Therapeutics. Karyopharm Announces Selinexor Clinical Data to be Presented at the International Society for Influenza and Other Respiratory Virus Diseases Antiviral Group Virtual Conference on Therapeutics for COVID-19. Media-Rel 2020;.
Media Release -
Karyopharm Therapeutics, Komodo Health. Komodo Health Teams Up with Karyopharm Therapeutics to Accelerate New Global Clinical Trial to Treat Patients with COVID-19. Media-Rel 2020;.
Media Release -
Karyopharm Therapeutics. Karyopharm to Evaluate Low Dose Selinexor as a Potential Treatment for Hospitalized Patients with COVID-19. Media-Rel 2020;.
Media Release -
PROMETRIKA, Karyopharm. PROMETRIKA and Karyopharm: Partners in Global COVID-19 Trial. Media-Rel 2020;.
Media Release -
European Clinical Trials Database. Trial-Reg 2023;.
Available from: URL: https://www.clinicaltrialsregister.eu -
Karyopharm Therapeutics. Karyopharm Announces Dosing of First Patient in Randomized Study Evaluating Low Dose Selinexor in Patients with Severe COVID-19 . Media-Rel 2020;.
Media Release -
Karyopharm Therapeutics. Karyopharm Reports Second Quarter 2020 Financial Results and Highlights Recent Company Progress. Media-Rel 2020;.
Media Release -
Precision for Medicine. Precision For Medicine Partners With Karyopharm Therapeutics To Initiate New Global Clinical Trial To Treat Patients With COVID-19. Media-Rel 2020;.
Media Release
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