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

NCT04355676 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: XPORT-CoV-1002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronavirus Infection

Keywords

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

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

  Baseline to Day 14

Secondary Outcomes (23)

• Time to Clinical Improvement (TTCI)

  Up to Day 28

• Overall Death Rate

  Day 14, Day 28

• Rate of Mechanical Ventilation

  Up to Day 28

• Time to Mechanical Ventilation

  Up to Day 28

• Overall Survival

  Up to Day 28

Study Arms (2)

Selinexor 40mg

EXPERIMENTAL

Participants 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).

Drug: Selinexor

Selinexor 20mg

EXPERIMENTAL

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

Interventions

Selinexor DRUG

20 mg selinexor oral tablet.

Also known as: KPT-330, XPOVIO

Selinexor 20mg; Selinexor 40mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Karyopharm Therapeutics Inc: lead

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

selinexor

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2020
• First Posted: April 21, 2020
• Study Start: April 30, 2020
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: January 20, 2023

Record last verified: 2023-01