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

Alexandria University66 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Acute Respiratory Distress Syndrome Cytokine Release Syndrome Pulmonary Fibrosis

Interventions

cyclosporineDRUG

Dose of Cyclosporine oral capsule of 6 mg/kg/day divided into two doses with normal kidney function for 8-14 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Current infection with COVID-19 2. written informed consent 3. 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. 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. \-

Locations (1)

Alexandria university

Alexandria, Egypt

Outcomes

Primary Outcomes

Percentage of subjects with a 6-point ordinal scale showing each severity level

i. Death ii. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation iii. Hospitalized, on non-invasive ventilation or high flow oxygen devices iv. Hospitalized, requiring supplemental oxygen v. Hospitalized, not requiring supplemental oxygen vi. Not hospitalized

Time frame: 7-14 days after randomization

Secondary Outcomes

Duration of hospital admission

efficacy of CsA (cyclosporine) in reducing days in hospital

Time frame: through study completion, an average of 4 weeks

Rate of decline OF Soluble interleukin-2 (IL-2) receptor alpha. (sCD25)

change from baseline in IL-2 levels

Time frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks)

Rate of decline OF interleukin-1

change from baseline in IL-1 levels

Time frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks)

Rate of decline OF interleukin-10(IL-10)

change from baseline in IL-10 levels

Time frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)

Rate of decline OF Interleukin-6,( IL-6)

change from baseline in IL-6levels

Time frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)

Rate of decline OF Tumour necrosis factor α (TNFα)

change from baseline in TNFα levels

Data from ClinicalTrials.gov

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