Clinical trial: Sarilumab for Patients With Moderate COVID-19 Disease (NCT04359901)

Eligibility criteria:
Study subjects will be inpatients with confirmed SARS-CoV-2 testing. Testing is performed
        at the discretion of the treating physician. Only Veterans will be enrolled.

        Inclusion Criteria:

          1. Positive testing for novel coronavirus SARS-CoV-2019

          2. Patients with moderate COVID-19 disease as defined clinically:

               1. Score of 1-3 (out of 3) on a modified Brescia COVID respiratory severity score
                  (BCRSS), elements of which include wheezing or inability to speak complete
                  sentences without effort, respiratory rate ≥22, O2 saturation ≤ 94% with or
                  without supplemental oxygen, or requiring ≥2L supplemental oxygen to maintain O2
                  Sat >94% in patients without previously documented hypoxia or baseline
                  oxygenation requirement; either is equal to one point on the score) all within a
                  24-hour period prior to enrollment, and/or any worsening of chest X-ray (CXR)
                  findings after COVID-19 diagnosis

               2. Worsening of baseline oxygenation by at least 3%, or increase in oxygen
                  requirement by at least 2L, in patients with pre-existing hypoxemia or receiving
                  supplemental oxygen chronically.

               3. The BCRSS risk calculation score is available at:
                  https://www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm

        Exclusion Criteria:

          1. Critical disease, defined by need for mechanical ventilation

          2. Expected death within 48 hours

          3. Patients taking any of the following for chronic inflammatory diseases:
             glucocorticoids equivalent to prednisone > 10 mg/day (methylprednisolone > 8 mg/day,
             dexamethasone > 2 mg/day), a JAK inhibitor (tofacitinib, baricitinib, upadacitinib),
             or a biologic

               1. Use of chronic inhaled steroids is NOT an exclusion

               2. Current or recent short-term use of glucocorticoids for chronic conditions such
                  as COPD or gout is NOT an exclusion.

               3. Current use of glucocorticoids for COVID-19 is NOT an exclusion

               4. Use of biologics for non-inflammatory diseases is NOT an exclusion

          4. Receipt of any IL-6 inhibitor within 3 months prior to enrollment in the trial

          5. Pregnancy, due to lack of fetal monitoring capabilities

          6. Patients enrolled in other interventional clinical trials, including for COVID-19.
             Patients enrolled in non-interventional studies or receiving non-FDA-approved drugs
             for compassionate use are not excluded.

          7. Patients whose goal of care is comfort measures only

          8. Inability to provide informed consent, or absence of a legally authorized
             representative to provide informed consent.

          9. Severe psychiatric disease that prevents compliance with typical medical care.

         10. Initial positive test for active infection with novel coronavirus SARS-CoV-2019 was >4
             weeks prior to current admission.
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