AzTrials
AzTrials

Coronavirus InfectionPhase 2NCT04355676

Evaluation of Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Participants With Moderate or Severe COVID-19

A Phase 2 study testing Selinexor in people with Coronavirus Infection, run by Karyopharm Therapeutics Inc.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

The main purpose of this study is to evaluate the activity, safety and reduction in mortality of two regimens of low dose selinexor (KPT-330) in patients with moderate or severe COVID-19. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronavirus Infection
What is being tested?
Selinexor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Apr 2020to 30 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed laboratory diagnosis of SARS-CoV2 by standard approved reverse transcription polymerase chain reaction (RT-PCR) assay or equivalent approved testing (by local labs).
  • Currently hospitalized and consented within the first 48 hours of hospitalization.
  • Informed consent provided as above (patients must be dosed with study drug within 12 hours of consent).
  • Has symptoms of moderate or severe COVID-19 as demonstrated by:
  • Moderate COVID-19:
  • Currently hospitalized and requiring medical care for COVID-19, and
Show all 13Show fewer
  • Peripheral capillary oxygen saturation (SpO2, pulse oximetry) > 94% on room air at screening, and
  • Radiographic evidence of pulmonary infiltrates
  • Severe COVID-19:
  • 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 AND
  • Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: respiratory rate ≥ 30 breaths/minute (min), heart rate ≥ 125/min, Oxygen saturation (SpO2) <93% on room air or requires > 2L/minute oxygen by NC in order to maintain SaO2 ≥93%, PaO2/FiO2 <300 millimeter per mercury (mm/hg)
  • Female patients of childbearing potential must have a negative serum pregnancy test at Screening and must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.
  • Males who are sexually active must commit to use a highly effective method of contraception while receiving selinexor and for 3 months after the last selinexor dose, or consent to total sexual abstinence (abstinence must occur from enrollment and continue for 3 months after the last selinexor dose).

Who cannot join

  • Evidence of critical COVID-19 based on:
  • Respiratory failure (defined by endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations)
  • Septic shock (defined by SBP < 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
  • Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are not permitted.
Show all 16Show fewer
  • Inadequate hematologic parameters as indicated by the following labs:
  • Patients with severe neutropenia (ANC <1,000 x 10^9/liter [L]) or
  • Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)
  • Inadequate renal function as indicated by creatinine clearance (CrCl) <20 milliliter per minute (mL/min) using the formula of Cockcroft and Gault.
  • Inadequate hepatic function defined as AST or ALT > 5x the upper limit of normal OR serum direct bilirubin > 2.5x the upper limit of normal.
  • Hyponatremia defined as sodium < 135 milliequivalents per liter (mEq/L).
  • In the opinion of the Investigator, patients who are below their ideal body weight and would be unduly impacted by changes in their weight.
  • Unable to take oral medication when informed consent is obtained.
  • Patients with a legal guardian or who are incarcerated.
  • Pregnant and breastfeeding women.

About this study

Official title: A Phase 2 Randomized, Open-Label, Multicenter Study to Evaluate the Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Patients With Moderate or Severe COVID-19

The main purpose of this study is to evaluate the activity, safety and reduction in mortality of two regimens of low dose selinexor (KPT-330) in patients with moderate or severe COVID-19.

Being tested
Selinexor
Keywords
COVID-19, SARS-CoV-2
Medical subject headings
Coronavirus Infections, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SelinexorDrug

    Also called KPT-330, XPOVIO

    20 mg selinexor oral tablet.

Study groups in NCT04355676
Study groupRoleWhat they receive
Selinexor 40mgExperimentalParticipants will receive 40 milligram (mg) of selinexor as oral tablets on Days 1 and 3 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).
Receives: Drug: Selinexor
Selinexor 20mgExperimentalParticipants 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).
Receives: Drug: Selinexor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale

    Measured: Baseline to Day 14

Secondary outcomes (23)

  1. Time to Clinical Improvement (TTCI)

    Measured: Up to Day 28

  2. Overall Death Rate

    Measured: Day 14, Day 28

  3. Rate of Mechanical Ventilation

    Measured: Up to Day 28

  4. Time to Mechanical Ventilation

    Measured: Up to Day 28

  5. Overall Survival

    Measured: Up to Day 28

  6. Time to Improvement (2 points) in Clinical Measures Using the Ordinal Scale

    Measured: Up to Day 28

  7. Time to Intensive Care Unit (ICU) Admission

    Measured: Up to Day 28

  8. Rate of Intensive Care Unit (ICU) Admission

    Measured: Up to Day 28

  9. Length of Stay in Hospital

    Measured: Up to Day 28

  10. Percentage of Participants Discharged From Hospital

    Measured: Up to Day 28

  11. Length of Stay in Intensive Care Unit (ICU)

    Measured: Up to Day 28

  12. Duration of Oxygen Supplementation

    Measured: Up to Day 28

  13. Duration of Mechanical Ventilation

    Measured: Up to Day 28

  14. Time to Clinical Improvement in Participants ≤ 70 Years Old

    Measured: Up to Day 28

  15. Time to Clinical Improvement in Participants > 70 Years Old

    Measured: Up to Day 28

  16. Time to Clinical Improvement in Participants with Pre-existing Diseases

    Measured: Up to Day 28

  17. Change in Oxygenation Index

    Measured: Up to Day 28

  18. Time to Improvement of One Point Using WHO Ordinal Scale Improvement

    Measured: Up to Day 28

  19. Percentage of Participants Experiencing WHO Ordinal Scale Improvement of >1 point

    Measured: Up to Day 28

  20. Change from Baseline in C-reactive protein (CRP) Levels

    Measured: Up to Day 28

  21. Change from Baseline in Ferritin Levels

    Measured: Up to Day 28

  22. Change from Baseline in Lactate Dehydrogenase (LDH) Levels

    Measured: Up to Day 28

  23. Number of Participants with Adverse Events (AE)

    Measured: From start of study drug administration up to follow-up (Day 30)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2020
  2. Study start30 Apr 2020
  3. Primary completion30 Aug 2020
  4. Study completion30 Aug 2020

Why it stopped: No participants enrolled

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04355676
Sponsor's protocol ID
XPORT-CoV-1002
Status last verified
Jan 2023
First submitted
17 Apr 2020
Last updated
20 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor in people with Coronavirus Infection, run by Karyopharm Therapeutics Inc.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale (time frame: Baseline to Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04355676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in