The study to evaluate the effect of cyclosporine ( IL2 inhibitor and antiviral) verse standard care treatment on decrease ADRS, hyper inflammation, hypercytokinemia, and the mortality rate
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)
Drug: cyclosporine
Dose of Cyclosporine oral capsule of 6 mg/kg/day divided into two doses with normal kidney function for 8-14 days
Other Name: interleukin-2
Inclusion Criteria:
1. Current infection with COVID-19
2. written informed consent
3. Confirmed diagnosis of COVID-19 by PCR and/or Positive Serology or any existing and
validated diagnostic COVID-19 parameters during this time.
4. 18yrs ≥ Age <66 yrs
5. Chest X-ray showing suggestive of COVID-19 disease.
6. Both gender
7. The presence of Pulmonary fibrosis or hyper inflammation signs or A syndrome of
cytokine release defined as ANY of the following::
1. Leukopenia or lymphopenia,
2. Ferritin > 500ng/mL or D-dimers ≥ 500 ng/mL
3. Hs>90
Exclusion Criteria:
1. Lactation and Pregnancy women
2. unlikely to survive beyond 48h
3. Need for mechanical ventilation.
4. cases of multiorgan failure or abnormal renal function and shock.
5. malignancies, autoimmune disease, Perforation of the bowels or diverticulitis.
6. active bacterial or fungal infection.
7. 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.
8. Levels of serum transaminase >5 upper references rang
9. Symptoms of active tuberculosis or human immunodeficiency virus (HIV) positivity
10. the patient receiving Vaccines: Live, attenuated vaccines
11. Subjects received monoclonal antibodies within one week before admission.
12. Patients receiving high-dose systemic steroids (> 20 mg methylprednisolone or
equivalent), immunosuppressant or immunomodulatory drugs
13. Contraindications for use in people with psoriasis include concomitant treatment with
methotrexate, other immunosuppressant agents, coal tar, or radiation therapy.
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Amira zidane
00201024585329
amira.zidan2yahoo@gmail.com
Ahmed Gad
00201144666619
ahmedyoussf0416@gmail.com
Maged El-Setouhy, Study Director
Alexandria University