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

NCT04979884 | Completed Phase 3

• 1 other identifier: cyclosporine in COVID-19
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

COVID-19; Cyclosporine; secondary haemophagocytic lymphohistiocytosis (sHLH); acute respiratory distress syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with a 6-point ordinal scale showing each severity level

  i. Death ii. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation iii. Hospitalized, on non-invasive ventilation or high flow oxygen devices iv. Hospitalized, requiring supplemental oxygen v. Hospitalized, not requiring supplemental oxygen vi. Not hospitalized

  7-14 days after randomization

Secondary Outcomes (18)

• Duration of hospital admission

  through study completion, an average of 4 weeks

• Rate of decline OF Soluble interleukin-2 (IL-2) receptor alpha. (sCD25)

  Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks)

• Rate of decline OF interleukin-1

  Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks)

• Rate of decline OF interleukin-10(IL-10)

  Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)

• Rate of decline OF Interleukin-6,( IL-6)

  Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)

Study Arms (2)

cyclosporine

EXPERIMENTAL

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

Drug: cyclosporine

Standard of care treatment

ACTIVE COMPARATOR

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

Drug: cyclosporine

Interventions

cyclosporine DRUG

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

Also known as: interleukin-2

Standard of care treatment; cyclosporine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• yrs ≥ 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,
• Ferritin \> 500ng/mL or D-dimers ≥ 500 ng/mL
• Hs\>90

You may not qualify if:

• 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.
• 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
• Symptoms of active tuberculosis or human immunodeficiency virus (HIV) positivity
• the patient receiving Vaccines: Live, attenuated vaccines
• Subjects received monoclonal antibodies within one week before admission.
• Patients receiving high-dose systemic steroids (\> 20 mg methylprednisolone or equivalent), immunosuppressant or immunomodulatory drugs
• Contraindications for use in people with psoriasis include concomitant treatment with methotrexate, other immunosuppressant agents, coal tar, or radiation therapy.

Sponsors & Collaborators

• Alexandria University: lead
• Science and Technology Development Fund (STDF), ,Egypt: collaborator

Study Sites (1)

Alexandria university

Alexandria, 21523, Egypt

Location

Related Publications (3)

• Fellman CL, Archer TM, Wills RW, Mackin AJ. Effects of cyclosporine and dexamethasone on canine T cell expression of interleukin-2 and interferon-gamma. Vet Immunol Immunopathol. 2019 Oct;216:109892. doi: 10.1016/j.vetimm.2019.109892. Epub 2019 Jul 11.

  PMID: 31446206 BACKGROUND

• Damaso CR, Keller SJ. Cyclosporin A inhibits vaccinia virus replication in vitro. Arch Virol. 1994;134(3-4):303-19. doi: 10.1007/BF01310569.

  PMID: 8129618 BACKGROUND

• Ciesek S, Steinmann E, Wedemeyer H, Manns MP, Neyts J, Tautz N, Madan V, Bartenschlager R, von Hahn T, Pietschmann T. Cyclosporine A inhibits hepatitis C virus nonstructural protein 2 through cyclophilin A. Hepatology. 2009 Nov;50(5):1638-45. doi: 10.1002/hep.23281.

  PMID: 19821520 BACKGROUND

MeSH Terms

Conditions

Cytokine Release Syndrome; Pulmonary Fibrosis; COVID-19; Respiratory Distress Syndrome

Interventions

Cyclosporine; Interleukin-2

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiration Disorders

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Maged El-Setouhy

  Alexandria University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 28, 2021
• Study Start: January 3, 2022
• Primary Completion: September 9, 2022
• Study Completion: December 9, 2022
• Last Updated: May 14, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)