Official Title
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
Brief 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

Detailed 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)

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

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

Eligibility Criteria

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.

-

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Contacts

Amira zidane
00201024585329
amira.zidan2yahoo@gmail.com

Ahmed Gad
00201144666619
ahmedyoussf0416@gmail.com

Maged El-Setouhy, Study Director
Alexandria University

Science and Technology Development Fund (STDF), ,Egypt
NCT Number
Keywords
Covid-19
Cyclosporine
secondary haemophagocytic lymphohistiocytosis (sHLH)
Acute Respiratory Distress Syndrome (ARDS)
MeSH Terms
COVID-19
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Pulmonary Fibrosis
Syndrome
Cytokine Release Syndrome
Cyclosporine
Interleukin-2
Cyclosporins