Clinical trial: Evaluation of Activity and Safety of Two Regimens of Low Dose Oral Selinexor in Participants With Moderate or Severe COVID-19 (NCT04355676)

Eligibility criteria:
Inclusion Criteria:

          -  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:

          1. Currently hospitalized and requiring medical care for COVID-19, and

          2. Peripheral capillary oxygen saturation (SpO2, pulse oximetry) > 94% on room air at
             screening, and

          3. Radiographic evidence of pulmonary infiltrates

        Severe COVID-19:

          1. 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

          2. 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 Criteria:

          -  Evidence of critical COVID-19 based on:

               1. 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)

               2. Septic shock (defined by SBP < 90 mm Hg, or Diastolic BP < 60 mm Hg)

               3. 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:

               1. Patients with severe neutropenia (ANC <1,000 x 10^9/liter [L]) or

               2. 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? 0