Description
Inclusion Criteria:
- 1. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
- 2. Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements.
- 3. Diagnosis with Mild or Moderate Pneumonia not requiring mechanical ventilation: Patient must have at least one of the following features:
- i. Bilateral pneumonia present on chest radiograph or computed tomography ii. Partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) on arterial blood gas showing: \>100mmHg and ≤ 300mmHg regardless of oxygen dose at time of testing.
- iii. Pulse oxygen saturation (SpO2) at rest ≤ 93% or any degree of hypoxia requiring supplemental oxygen
- 4. Patient agrees to storage of specimens for future testing.
- 5. Willingness to undergo mechanical ventilation for worsening
Exclusion Criteria:
- 1. Intubation with mechanical ventilation prior to study enrolment. High flow nasal cannula and non-invasive mechanical ventilation is allowed.
- 2. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses
- 3. Obstructive pneumonia induced by lung cancer or other known causes
- 4. Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer.
- 5. Patients who are participating in other therapeutic clinical trials within 30 days of consent.
- 6. History of long-term use of immunosuppressive agents including prednisone dose \>5mg daily over the 30 days prior to enrollment.
- 7. History of severe chronic respiratory disease and requirement for long-term oxygen therapy
- 8. Undergoing hemodialysis or peritoneal dialysis
- 9. Estimated or actual rate of creatinine clearance \< 15 ml/min
- 10. History of moderate and severe liver disease (Child-Pugh score \>12)
- 11. Substance abuse sufficient that the patient is unlikely to comply with testing requirements.
- 12. History of deep venous thrombosis, pulmonary embolism, cerebral vascular disease within the last 3 years
- 13. Known HIV, hepatitis virus, or syphilis infection
- 14. Co-Infection of tuberculosis, influenza virus, adenovirus and other respiratory infection virus
- 15. Moribund patient not expected to survive \> 24hours
- 16. Allergy to diphenhydramine, or hydrocortisone
- 17. Any condition unsuitable for the study as determined by the investigators
- 18. Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period.
- 19. Receipt of experimental therapy for COVID-19 with the exception of convalescent plasma, dexamethasone or another corticosteroid, or remdesivir in an open label study.
Ages Eligible for Study:
18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No