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

Last updated: May 12, 2025
Sponsor: Alexandria University
Overall Status: Completed

Phase

3

Condition

Cystic Fibrosis

Acute Respiratory Distress Syndrome (Ards)

Lung Injury

Treatment

cyclosporine

Clinical Study ID

NCT04979884
cyclosporine in COVID-19
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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/orPositive Serology or any existing and validated diagnostic COVID-19 parametersduring 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 ofcytokine release defined as any of the following::

  8. Leukopenia or lymphopenia,

  9. Ferritin > 500ng/mL or D-dimers ≥ 500 ng/mL

  10. Hs>90

Exclusion

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 yearbefore enrollment, supraventricular or ventricular arrhythmia needs treatment orintervention, 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 orequivalent), immunosuppressant or immunomodulatory drugs

  13. Contraindications for use in people with psoriasis include concomitant treatmentwith methotrexate, other immunosuppressant agents, coal tar, or radiation therapy.

Study Design

Total Participants: 66
Treatment Group(s): 1
Primary Treatment: cyclosporine
Phase: 3
Study Start date:
January 03, 2022
Estimated Completion Date:
December 09, 2022

Study Description

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)

Connect with a study center

  • Alexandria university

    Alexandria, 21523
    Egypt

    Site Not Available

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