Clinical trial: Effects of mTOR Inhibition With Sirolimus (RAPA) in Patients With COVID-19 to Moderate the Progression of ARDS (NCT04482712)

Eligibility criteria:
Inclusion Criteria:

          1. Over 60 years of age clinically judged to require hospitalization

          2. SARS-CoV2 infection documented by positive RT-PCR nasopharyngeal swab

          3. Mild to Moderate clinical status defined as clinical symptoms with or without
             pneumonia on imaging, with or without fever who are judged to require hospital
             admission

               1. Elevated ferritin

               2. Lymphopenia

               3. Bilateral opacities on chest x-ray

               4. Low pro-calcitonin

               5. Clinical signs suggestive of symptoms of mild illness with COVID-19 that could
                  include fever, cough, sore throat, malaise, headache, muscle pain,
                  gastrointestinal symptoms, without shortness of breath or dyspnea or moderate
                  illness with CoVID-19, such as respiratory rate ≥ 20 breaths per minute,
                  saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats
                  per minute.

        Exclusion Criteria:

          1. Known or suspected allergy to RAPA

          2. High pro-calcitonin

          3. SARS-CoV2 documented by negative RT-PCR nasopharyngeal swab

          4. Treatment with contraindicated concomitant medications: currently receiving
             immunosuppressants, including steroids, prior to enrollment, or with immunomodulators
             or immunosuppressant drugs, including but not limited to Inter leukin (IL)-6
             inhibitors, Tumor necrosis factor (TNF) inhibitors, anti-IL-1 agents and Janus kinase
             (JAK) inhibitors within 5 half-lives or 30 days (whichever is longer) prior to
             randomization.

          5. Currently receiving immunosuppressants, including steroids, prior to enrollment

          6. Serious underlying disease including but not limited to cardiac, pulmonary, renal,
             hepatic (bilirubin >1.5x Upper normal limit (ULN) or Aspartate Aminotransferase
             (AST)>ULN but bilirubin ≤ ULN), endocrine (diabetes) or psychiatric disorders judged
             to be at risk in participating by the inpatient attending physician or team

          7. Suspected or confirmed history of alcohol or substance abuse disorder

          8. Having participated in other drug trials in the past month

          9. Deemed otherwise unsuitable for the study by researchers

         10. Clinically judged to not require hospital admission
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 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