ow Dose Oral Selinexor in Patients with Severe COVID-19 Infectio

Phase 1

• Conditions: Severe COVID-19 Infection; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001411-25-GB
• Lead Sponsor: Karyopharm Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-06
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all the following criteria:
1. Age =18 years
2. Confirmed laboratory diagnosis of SARS-CoV2 by standard approved RT-PCR assay (local labs) within 7 days of enrollment.
3. Currently hospitalized.
4. Informed consent.
5. Has symptoms of severe COVID-19 as demonstrated by:
a. 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
b. Clinical signs indicative of lower respiratory infection with COVID-19, with at least one of the following: SpO2 <92% on room air in last 12 hours or requires =4 LPM oxygen by nasal canula, non-rebreather/Ventimask (or similar device) or high flow nasal canula in order to maintain SpO2 =92%, PaO2/FiO2 <300 mm/hg. Patients with COPD or chronic lung disease must demonstrate evidence of increased oxygen needs above baseline.
6. Elevated CRP > 2 x ULN.
7. Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics) are permitted. If in the physician’s judgement, it is in the best interest of the patient to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the patient’s chart and entered in the electronic case report form. Note: Patients who may have received plasma convalescent therapy > 48 hours prior to enrollment with no clinical improvement and who still meet criteria for severe COVID-19 may enroll. On study plasma convalescent therapy is not permitted. Patients who receive plasma convalescent therapy within 48 hours may be permitted to enroll based on discussion with sponsor.
8. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment. Highly effective methods of contraception are listed in Section 8.3.1. of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

Patients are excluded from the study if any of the following criteria apply:
1. Evidence of critical COVID-19 based on:
a. 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)
b. Septic shock (defined by investigator assessment or requiring vasopressors)
c. Multiple organ dysfunction/failure
2. In the opinion of the investigator, unlikely to survive for at least 48 hours from screening.
3. Inadequate hematologic parameters as indicated by the following labs:
a. Patients with severe neutropenia (ANC <1,000 x 109/L) or
b. Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)
4. Inadequate renal function and liver function as indicated by the following labs:
a. creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault
b. Aspartate transaminase (AST) or alanine transaminase (ALT) > 5x the upper limit of normal.
5. Hyponatremia defined as sodium less than 130 mEq/L
6. Unable to take oral medication when informed consent is obtained.
7. Patients with a legal guardian or who are incarcerated.
8. Pregnant and breastfeeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified