Status:
WITHDRAWN
Evaluation of Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Participants With Moderate or Severe COVID-19
Lead Sponsor:
Karyopharm Therapeutics Inc
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
- Pregnant and breastfeeding women.
Key Trial Info
Start Date :
April 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04355676
Start Date
April 30 2020
End Date
August 30 2020
Last Update
January 20 2023
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