Phase 1

• Conditions: Severe COVID-19 Infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]; MedDRA version: 20.0Level: LLTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 100000004862

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-17
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Age > or =18 years
2. Clinically suspected and subsequently confirmed; or laboratory diagnosis confirming patient is positive for SARS-CoV2 nucleic acid by RT-PCR (by local labs)
3. Currently hospitalized and consented within the first 48 hours of hospitalization
4. Informed consent provided as above
5. Has symptoms of severe COVID-19 as demonstrated by:
a. Respiratory rate > or = 24 breaths/minute OR
b. Pulse Oxygen Saturation (SpO 2 ) < or = 94% without oxygen supplementation, OR
c. PaO 2 /FiO 2 (fraction of inspired oxygen) < OR = 300 mm Hg
6. Concurrent anti-virals and/or anti-inflammatory agents (e.g., biologics, hydroxychloroquine) are permitted at baseline for patients entering the study
7. Female patients of childbearing potential must have a negative serum pregnancy test at Screening. Female patients of childbearing potential and fertile male patients who are sexually
active with a female of childbearing potential must use highly effective methods of contraception throughout the study and for 1 week following the last dose of study treatment.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

1. Evidence of critical COVID-19 based on:
a. Mechanical ventilation (invasive or non-invasive) or ECMO or hemofiltration required
b. Shock
2. In the opinion of the investigator, unlikely to survive for at least 48 hours from screening or anticipate mechanical ventilation within 48 hours
3. Inadequate renal and liver function as indicated by the following labs:
a. Creatinine clearance (CCL) <20 mL/min
b. Aspartate transaminase (AST) or alanine transaminase (ALT) >5 x upper limit of normal (ULN)
4. Unable to take oral medication

Study & Design

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