Safety and Therapeutic Efficacy of Cyclosporine Plus Standard of Care Treatment on ARDS in COVID -19 Patients at Alexandria University Hospitals in 2021: a Comparative Study

cyclosporine in COVID-19

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

2022-01-03

2022-09-09

2022-12-09

Completed

Early phase I

102

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. -

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 102, 'type': 'ACTUAL'}}

2023-07-27