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Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection (Coronavirus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04349098
Recruitment Status : Completed
First Posted : April 16, 2020
Results First Posted : November 1, 2021
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Karyopharm Therapeutics Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Coronavirus Infection
Interventions Drug: Selinexor
Other: Placebo
Enrollment 190
Recruitment Details This study was conducted at 20 sites in the United States of America,1 site in Austria, 3 sites in France and Israel, 2 sites in Spain, and 4 sites in the United Kingdom from 17 Apr 2020 to 05 Oct 2020.
Pre-assignment Details A total of 190 participants were enrolled and randomized, of which 188 participants received study treatment in this study.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26). Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Period Title: Overall Study
Started 103 87
Treated 102 86
Completed 65 61
Not Completed 38 26
Reason Not Completed
Death             16             8
Lost to Follow-up             11             8
Withdrawal by Subject             8             5
Other             3             5
Arm/Group Title Selinexor 20 mg Placebo Total
Hide Arm/Group Description Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26). Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26). Total of all reporting groups
Overall Number of Baseline Participants 103 87 190
Hide Baseline Analysis Population Description
PV 1-6 population included participants randomized into the study under protocol versions 1-6.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants 87 participants 190 participants
56.5  (16.12) 56.5  (14.64) 56.5  (15.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 87 participants 190 participants
Female
43
  41.7%
39
  44.8%
82
  43.2%
Male
60
  58.3%
48
  55.2%
108
  56.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 87 participants 190 participants
Hispanic or Latino
41
  39.8%
32
  36.8%
73
  38.4%
Not Hispanic or Latino
59
  57.3%
53
  60.9%
112
  58.9%
Unknown or Not Reported
3
   2.9%
2
   2.3%
5
   2.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants 87 participants 190 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   5.8%
4
   4.6%
10
   5.3%
Native Hawaiian or Other Pacific Islander
2
   1.9%
0
   0.0%
2
   1.1%
Black or African American
23
  22.3%
24
  27.6%
47
  24.7%
White
44
  42.7%
34
  39.1%
78
  41.1%
More than one race
19
  18.4%
14
  16.1%
33
  17.4%
Unknown or Not Reported
9
   8.7%
11
  12.6%
20
  10.5%
1.Primary Outcome
Title Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population included all participants who were randomized in the study with confirmed severe acute respiratory syndrome coronavirus (SARS-CoV2) infection under protocol version (PV) 6.0 and above, regardless of whether or not they receive study treatment.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 66 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
60.6
(47.8 to 72.4)
60.8
(46.1 to 74.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Selinexor 20 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6750
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.39 to 1.79
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With at Least a 2-Point Improvement in the Ordinal Scale up to Day 7
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PV 1-6 population included participants randomized into the study under protocol versions 1-6.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 103 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
30.1
(21.5 to 39.9)
32.2
(22.6 to 43.1)
3.Secondary Outcome
Title Percentage of Participants With at Least a 1-Point Improvement in the Ordinal Scale
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PV 1-6 population included participants randomized into the study under protocol versions 1-6.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 103 87
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Day 7
51.5
(41.4 to 61.4)
50.6
(39.6 to 61.5)
Day 14
72.8
(63.2 to 81.1)
72.4
(61.8 to 81.5)
4.Secondary Outcome
Title Time to Clinical Improvement of 2-points Using Ordinal Scale (TTCI-2)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all participants who were randomized in the study with confirmed SARS-CoV2 infection under protocol version 6.0 and above, regardless of whether or not they receive study treatment.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 66 51
Median (95% Confidence Interval)
Unit of Measure: Days
10.0
(8.0 to 14.0)
10.0
(8.0 to 14.0)
5.Secondary Outcome
Title Overall Death Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study with confirmed SARS-CoV2 infection under protocol version 6.0 and above, regardless of whether or not they receive study treatment.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 66 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
15.2
(7.5 to 26.1)
3.9
(0.5 to 13.5)
6.Secondary Outcome
Title Rate of Mechanical Ventilation (RMV)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study with confirmed SARS-CoV2 infection under protocol version 6.0 and above, regardless of whether or not they receive study treatment.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 66 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
13.6
(6.4 to 24.3)
11.8
(4.4 to 23.9)
7.Secondary Outcome
Title Rate of Intensive Care Unit (ICU) Admission
Hide Description The rate of ICU admission was defined as the percentage of participants with ICU admissions.
Time Frame Baseline up to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study with confirmed SARS-CoV2 infection under protocol version 6.0 and above, regardless of whether or not they receive study treatment.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 66 51
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
48.5
(36.0 to 61.1)
41.2
(27.6 to 55.8)
8.Secondary Outcome
Title Length of Hospitalization
Hide Description Length of hospitalization (days) was defined as (first hospital discharge date - date of randomization + 1).
Time Frame Baseline up to Day 67
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized in the study with confirmed SARS-CoV2 infection under protocol version 6.0 and above, regardless of whether or not they receive study treatment.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 66 51
Median (Full Range)
Unit of Measure: Days
9.0
(3 to 39)
9.0
(3 to 67)
9.Secondary Outcome
Title Change From Baseline in C-reactive Protein (CRP) Levels
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PV 1-6 population included participants randomized into the study under protocol versions 1-6. Here, "Number Analyzed" signified those participants who were evaluable for this outcome measure at a specified time-point.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 103 87
Mean (Standard Deviation)
Unit of Measure: milligram per liter (mg/L)
Change at Day 3 Number Analyzed 88 participants 74 participants
-47.9660  (99.06082) -42.9658  (89.09341)
Change at Day 5 Number Analyzed 83 participants 69 participants
-74.4735  (114.52388) -68.6191  (108.19671)
Change at Day 8 Number Analyzed 57 participants 45 participants
-83.3460  (93.83500) -74.4669  (117.66505)
Change at Day 12 Number Analyzed 31 participants 27 participants
-86.9158  (123.54705) -93.2744  (131.56709)
Change at Day 15 Number Analyzed 10 participants 15 participants
-87.9800  (121.19999) -98.7940  (87.65276)
Change at Day 19 Number Analyzed 7 participants 9 participants
-66.2143  (86.55049) -124.3233  (102.04161)
Change at Day 22 Number Analyzed 10 participants 5 participants
-90.7100  (149.25579) -47.5620  (171.49171)
Change at Day 26 Number Analyzed 5 participants 5 participants
-37.2800  (141.41390) -129.5020  (46.26178)
10.Secondary Outcome
Title Change From Baseline in Ferritin Levels
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PV 1-6 population included participants randomized into the study under protocol versions 1-6. Here, "Number Analyzed" signified those participants who were evaluable for this outcome measure at a specified timepoint.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 103 87
Mean (Standard Deviation)
Unit of Measure: microgram/liter (mcg/L)
Change at Day 3 Number Analyzed 82 participants 70 participants
80.8415  (759.10075) -61.9843  (542.09460)
Change at Day 5 Number Analyzed 79 participants 63 participants
-25.7000  (856.16619) -155.3111  (773.76777)
Change at Day 8 Number Analyzed 53 participants 39 participants
226.6113  (1673.46162) -292.2462  (738.07874)
Change at Day 12 Number Analyzed 29 participants 25 participants
193.5793  (1203.33385) -352.5280  (741.13673)
Change at Day 15 Number Analyzed 10 participants 14 participants
204.3900  (557.29217) -356.8429  (476.04151)
Change at Day 19 Number Analyzed 6 participants 8 participants
-15.9333  (462.40358) -231.2374  (599.98919)
Change at Day 22 Number Analyzed 10 participants 4 participants
-103.9900  (636.89555) -102.0000  (417.51247)
Change at Day 26 Number Analyzed 6 participants 4 participants
-150.1167  (535.94141) -25.7500  (231.43232)
11.Secondary Outcome
Title Change From Baseline in Lactate Dehydrogenase (LDH) Levels
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PV 1-6 population included participants randomized into the study under protocol versions 1-6. Here, "Number Analyzed" signified those participants who were evaluable for this outcome measure at a specified time-point.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 103 87
Mean (Standard Deviation)
Unit of Measure: units/liter (U/L)
Change at Day 3 Number Analyzed 76 participants 63 participants
-13.86  (148.231) -11.86  (151.630)
Change at Day 5 Number Analyzed 74 participants 62 participants
-49.12  (175.722) 31.85  (326.281)
Change at Day 8 Number Analyzed 52 participants 40 participants
-75.85  (264.840) -10.93  (166.876)
Change at Day 12 Number Analyzed 28 participants 25 participants
-107.39  (198.092) -16.84  (232.605)
Change at Day 15 Number Analyzed 11 participants 14 participants
-71.82  (193.543) -51.50  (148.063)
Change at Day 19 Number Analyzed 8 participants 7 participants
-96.38  (200.164) -74.14  (114.271)
Change at Day 22 Number Analyzed 10 participants 5 participants
-129.70  (177.454) -75.40  (43.569)
Change at Day 26 Number Analyzed 6 participants 4 participants
-169.50  (213.481) 4.50  (130.733)
12.Secondary Outcome
Title Changes From Baseline in Blood Plasma Cytokines Levels-Interleukin-6 (IL-6)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
PV 1-6 population included participants randomized into the study under protocol versions 1-6. Here, Overall Number of participants analyzed included all participants with baseline data and "Number Analyzed" signified those participants who were evaluable for this outcome measure at a specified time-point.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 103 87
Mean (Standard Deviation)
Unit of Measure: nanograms/milliliter (ng/mL)
Change at Day 3 Number Analyzed 38 participants 23 participants
-19.931  (51.2072) 2.046  (49.0258)
Change at Day 5 Number Analyzed 38 participants 26 participants
-10.786  (102.9160) -77.509  (408.0085)
Change at Day 8 Number Analyzed 28 participants 15 participants
-13.909  (161.6803) 183.728  (662.7908)
Change at Day 12 Number Analyzed 13 participants 9 participants
276.289  (1541.3692) 223.637  (715.5904)
Change at Day 15 Number Analyzed 4 participants 4 participants
-34.850  (28.6357) 207.625  (408.5783)
Change at Day 22 Number Analyzed 3 participants 0 participants
-8.600  (11.8072)
Change at Day 26 Number Analyzed 1 participants 0 participants
-23.400
13.Secondary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All-treat population consisted of the subset of ITT participants who took at least one dose of study treatment on this study.
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description:
Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
Overall Number of Participants Analyzed 102 86
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with TEAEs
75
  73.5%
49
  57.0%
Participants with Serious TEAEs
23
  22.5%
14
  16.3%
Time Frame From start of study drug administration up to Day 58
Adverse Event Reporting Description All-treat population consisted of the subset of ITT participants who took at least one dose of study treatment on this study.
 
Arm/Group Title Selinexor 20 mg Placebo
Hide Arm/Group Description Participants received a single dose of Selinexor 20 milligrams (mg) tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26). Participants received a single dose of placebo matched to selinexor tablets orally on Days 1, 3 and 5 of each week for up to 2 weeks. The participant tolerated therapy and showed clinical benefit, dosing continued for an additional 2 weeks (on Days 15, 17, 19, 22, 24, and 26).
All-Cause Mortality
Selinexor 20 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   16/102 (15.69%)   8/86 (9.30%) 
Hide Serious Adverse Events
Selinexor 20 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   23/102 (22.55%)   14/86 (16.28%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia * 1  1/102 (0.98%)  0/86 (0.00%) 
Cardiac disorders     
Atrial fibrillation * 1  1/102 (0.98%)  1/86 (1.16%) 
Cardiac arrest * 1  2/102 (1.96%)  0/86 (0.00%) 
Myocardial infarction * 1  0/102 (0.00%)  2/86 (2.33%) 
Cardiac failure * 1  1/102 (0.98%)  0/86 (0.00%) 
Long QT syndrome * 1  1/102 (0.98%)  0/86 (0.00%) 
Gastrointestinal disorders     
Intestinal ischaemia * 1  0/102 (0.00%)  1/86 (1.16%) 
General disorders     
Multiple organ dysfunction syndrome * 1  0/102 (0.00%)  2/86 (2.33%) 
Systemic inflammatory response syndrome * 1  1/102 (0.98%)  0/86 (0.00%) 
Infections and infestations     
COVID-19 * 1  0/102 (0.00%)  2/86 (2.33%) 
Pneumonia * 1  1/102 (0.98%)  1/86 (1.16%) 
Sepsis * 1  0/102 (0.00%)  1/86 (1.16%) 
Viral myocarditis * 1  1/102 (0.98%)  0/86 (0.00%) 
Injury, poisoning and procedural complications     
Procedural pneumothorax * 1  1/102 (0.98%)  0/86 (0.00%) 
Metabolism and nutrition disorders     
Metabolic acidosis * 1  0/102 (0.00%)  1/86 (1.16%) 
Nervous system disorders     
Cerebrovascular accident * 1  0/102 (0.00%)  1/86 (1.16%) 
Psychiatric disorders     
Catatonia * 1  1/102 (0.98%)  0/86 (0.00%) 
Renal and urinary disorders     
Acute kidney injury * 1  2/102 (1.96%)  1/86 (1.16%) 
Renal failure * 1  1/102 (0.98%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure * 1  6/102 (5.88%)  2/86 (2.33%) 
Pulmonary embolism * 1  4/102 (3.92%)  2/86 (2.33%) 
Acute respiratory failure * 1  2/102 (1.96%)  2/86 (2.33%) 
Pneumothorax * 1  2/102 (1.96%)  0/86 (0.00%) 
Hypoxia * 1  1/102 (0.98%)  0/86 (0.00%) 
Pneumonia aspiration * 1  0/102 (0.00%)  1/86 (1.16%) 
Respiratory distress * 1  0/102 (0.00%)  1/86 (1.16%) 
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Selinexor 20 mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   69/102 (67.65%)   45/86 (52.33%) 
Blood and lymphatic system disorders     
Anaemia * 1  9/102 (8.82%)  1/86 (1.16%) 
Lymphopenia * 1  5/102 (4.90%)  2/86 (2.33%) 
Leukopenia * 1  5/102 (4.90%)  1/86 (1.16%) 
Gastrointestinal disorders     
Constipation * 1  14/102 (13.73%)  9/86 (10.47%) 
Nausea * 1  13/102 (12.75%)  6/86 (6.98%) 
Diarrhoea * 1  10/102 (9.80%)  4/86 (4.65%) 
Infections and infestations     
COVID-19 * 1  5/102 (4.90%)  0/86 (0.00%) 
Investigations     
Aspartate aminotransferase increased * 1  9/102 (8.82%)  7/86 (8.14%) 
Alanine aminotransferase increased * 1  8/102 (7.84%)  4/86 (4.65%) 
Metabolism and nutrition disorders     
Hyponatraemia * 1  24/102 (23.53%)  5/86 (5.81%) 
Hyperglycaemia * 1  7/102 (6.86%)  3/86 (3.49%) 
Hypoalbuminaemia * 1  4/102 (3.92%)  5/86 (5.81%) 
Hypokalaemia * 1  5/102 (4.90%)  3/86 (3.49%) 
Hypophosphataemia * 1  5/102 (4.90%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Hypoxia * 1  6/102 (5.88%)  2/86 (2.33%) 
Vascular disorders     
Hypotension * 1  3/102 (2.94%)  5/86 (5.81%) 
1
Term from vocabulary, MedDRA 23.0
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Jatin Shah, MD
Organization: Karyopharm Therapeutics Inc
Phone: (617) 658-0600
EMail: jshah@karyopharm.com
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Responsible Party: Karyopharm Therapeutics Inc
ClinicalTrials.gov Identifier: NCT04349098    
Other Study ID Numbers: XPORT-CoV-1001
2020-001411-25 ( EudraCT Number )
First Submitted: April 14, 2020
First Posted: April 16, 2020
Results First Submitted: October 5, 2021
Results First Posted: November 1, 2021
Last Update Posted: January 20, 2023