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

Alexandria University

Status and phase: Completed; Phase 3

Conditions: Pulmonary Fibrosis; Cytokine Release Syndrome; COVID-19 Acute Respiratory Distress Syndrome

Treatments: Drug: cyclosporine

Study type: Interventional

Funder types: Other

Identifiers

NCT04979884

cyclosporine in COVID-19

Details and patient eligibility

About

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

Full 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)

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 2 patient groups

cyclosporine

Experimental group

Description:

patients will receive cyclosporine + (standard care treatment (± anticoagulant± antibiotic± antipyretic± steroid) according to Alexandria university hospitals protocol )

Treatment:

Drug: cyclosporine

Standard of care treatment

Active Comparator group

Description:

patients will receive standard treatment (antiviral ± anticoagulant± antibiotic± antipyretic± steroid± interleukin ) according to Alexandria university hospitals protocol.

Treatment:

Drug: cyclosporine