COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04349098

Dayana Michel

Jatin Shah, jshah@karyopharm.com (PI email not reported)

2020-04-16

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: - confirmed laboratory diagnosis of sars-cov2 by standard fda-approved reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent fda-approved testing (local labs). - currently hospitalized. - informed consent provided as above (it is recommended that participants are dosed with study drug within 12 hours of consent). - has symptoms of severe covid-19 as demonstrated by: - 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. - clinical signs indicative of lower respiratory infection with covid-19, with at least one of the following: sao2 <92% on room air in last 12 hours or requires > 4 liters per minute (lpm) oxygen by nasal canula, non-rebreather/ventimask or high flow nasal canula in order maintain sao2 ≥92%, pao2/fio2 <300 millimeter per mercury (mm/hg). - elevated c-reactive protein (crp) > 2 x upper limit of normal (uln). - concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted. if in the physician's judgment, it is in the best interest of the participant to use anti-viral or anti-inflammatory treatments, these treatments are to be documented in the participant's chart and entered in the electronic case report form. - female participants of childbearing potential must have a negative serum pregnancy test at screening. female participants of childbearing potential and fertile male participants must use highly effective methods of contraception throughout the study and for 3 months following the last dose of study treatment.

- evidence of critical covid-19 based on: - 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) - septic shock (defined by systolic blood pressure [bp] < 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. - inadequate hematologic parameters as indicated by the following labs: - participants with severe neutropenia (anc <1000 x 10^9/l) or - thrombocytopenia (e.g., platelets <100,000 per microliter of blood) - inadequate renal and liver function as indicated by the following labs: - creatinine clearance (crcl) <20 ml/min using the formula of cockcroft and gault - aspartate transaminase (ast) or alanine transaminase (alt) > 5 x uln - hyponatremia defined as sodium < 135 milliequivalents per liter (meq/l). - unable to take oral medication when informed consent is obtained. - participants with a legal guardian or who are incarcerated. - treatment with strong cyp3a inhibitors or inducers. - pregnant and breastfeeding women.

2

Karyopharm Therapeutics Inc

18

None

Austria;France;Israel;Spain;United Kingdom;United States

Severe disease at enrollment

6: Severe disease at enrollment

190

Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale

None

Phase 2

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