Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria … (NCT04979884) | Clinical Trial Compass
CompletedPhase 3
Safety and Effectiveness of Cyclosporin in the Management of COVID19 ARDS Patients in Alexandria University Hospital
Egypt66 participantsStarted 2022-01-03
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Current infection with COVID-19
✓. written informed consent
✓. 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.
✓. 18yrs ≥ Age \<66 yrs
✓. Chest X-ray showing suggestive of COVID-19 disease.
✓. Both gender
✓. The presence of Pulmonary fibrosis or hyper inflammation signs or A syndrome of cytokine release defined as any of the following::
✓. Leukopenia or lymphopenia,
Exclusion criteria
✕. Lactation and Pregnancy women
✕. unlikely to survive beyond 48h
✕. Need for mechanical ventilation.
✕. cases of multiorgan failure or abnormal renal function and shock.
✕. malignancies, autoimmune disease, Perforation of the bowels or diverticulitis.
✕. active bacterial or fungal infection.
✕
What they're measuring
1
Percentage of subjects with a 6-point ordinal scale showing each severity level
. 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.
✕. Levels of serum transaminase \>5 upper references rang