Learn about Research & Clinical Trials

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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. -

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04979884
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Alexandria University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Maged El-Setouhy
Principal Investigator Affiliation	Alexandria University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	COVID-19 Acute Respiratory Distress Syndrome, Cytokine Release Syndrome, Pulmonary Fibrosis

Additional Details

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)

Arms & Interventions

Arms

Experimental: cyclosporine

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

Active Comparator: Standard of care treatment

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

Interventions

Drug: - cyclosporine

Dose of Cyclosporine oral capsule of 6 mg/kg/day divided into two doses with normal kidney function for 8-14 days

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Amira zidane

amira.zidan2yahoo@gmail.com

00201024585329

For additional contact information, you can also visit the trial on clinicaltrials.gov.