Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital

To test the efficacy of IL-2 inhibitors (Cyclosporine) compared to the Standard of care according to hospital protocol on COVID-19 patients concerning the clinical outcome (cytokines level, clinical improvement, and PCR of SARS-CoV-2 through the study period).

AIM:

The slow progression of the disease, improving survival among COVID-19 patients, and Standard assessment of patient improvement.

• Standard assessment of patient improvement:
• PCR-SARS-CoV-2 negative
• No fever
• No cytopenia (Hb ≥90 g/L, ANC ≥0.5x109/L, platelets ≥100x109/L) •
• No hyperferritinemia ≥500 μg/L
• (Decrease of IL2)

Inclusion criteria

• Current infection with COVID-19
• written informed consent
• Confirmed diagnosis of COVID-19 by PCR (polymerase chain reaction) tests and/or Positive Serology or any existing and validated diagnostic COVID-19 parameters during this time.
• 18yrs ≥ Age <66 yrs
• Chest X-ray showing suggestive of COVID-19 disease.
• Both gender
• The presence of Pulmonary fibrosis or hyper inflammation signs or A syndrome of cytokine release defined as any of the following::

• Leukopenia or lymphopenia,
• Ferritin > 500ng/mL or D-dimers ≥ 500 ng/mL
• Hs>90

Exclusion criteria

• Lactation and Pregnancy women
• unlikely to survive beyond 48h
• Need for mechanical ventilation.
• cases of multiorgan failure or abnormal renal function and shock.
• malignancies, autoimmune disease, Perforation of the bowels or diverticulitis.
• active bacterial or fungal infection.
• We define impairment of cardiac function as poorly controlled heart diseases, cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia needs treatment or intervention, Uncontrolled hypertension (>180/110 mmHg.
• Levels of serum transaminase >5 upper references rang
• Symptoms of active tuberculosis or human immunodeficiency virus (HIV) positivity
• the patient receiving Vaccines: Live, attenuated vaccines
• Subjects received monoclonal antibodies within one week before admission.
• Patients receiving high-dose systemic steroids (> 20 mg methylprednisolone or equivalent), immunosuppressant or immunomodulatory drugs
• Contraindications for use in people with psoriasis include concomitant treatment with methotrexate, other immunosuppressant agents, coal tar, or radiation therapy.

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