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

July 24, 2023 updated by: Alexandria University

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

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

Study Overview

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)

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Alexandria, Egypt, 21523
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cyclosporine
patients will receive cyclosporine + (standard care treatment (± anticoagulant± antibiotic± antipyretic± steroid) according to Alexandria university hospitals protocol )
Dose of Cyclosporine oral capsule of 6 mg/kg/day divided into two doses with normal kidney function for 8-14 days
Other Names:
  • interleukin-2
Active Comparator: Standard of care treatment
patients will receive standard treatment (antiviral ± anticoagulant± antibiotic± antipyretic± steroid± interleukin ) according to Alexandria university hospitals protocol.
Dose of Cyclosporine oral capsule of 6 mg/kg/day divided into two doses with normal kidney function for 8-14 days
Other Names:
  • interleukin-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects with a 6-point ordinal scale showing each severity level
Time Frame: 7-14 days after randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of decline OF Soluble interleukin-2 (IL-2) receptor alpha. (sCD25)
Time Frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks)
change from baseline in IL-2 levels
Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks)
Rate of decline OF interleukin-1
Time Frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks)
change from baseline in IL-1 levels
Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks)
Rate of decline OF interleukin-10(IL-10)
Time Frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)
change from baseline in IL-10 levels
Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)
Rate of decline OF Interleukin-6,( IL-6)
Time Frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)
change from baseline in IL-6levels
Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)
Rate of decline OF Tumour necrosis factor α (TNFα)
Time Frame: Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)
change from baseline in TNFα levels
Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks)
Time to 50% a decrease of ferritin levels compared to peak value during trial
Time Frame: up to 28 days
change from baseline in ferritin levels
up to 28 days
Lung imaging improvement time
Time Frame: up to 28 days
COVID19 Lung imaging determination
up to 28 days
Time for non-invasive or invasive initial use
Time Frame: during hospital admission (up to 28 days)]
efficacy of CSA in reducing days of ventilators
during hospital admission (up to 28 days)]
Time to improvement in oxygenation
Time Frame: up to 28 days) from hospitalization
defined as independence from supplemental oxygen
up to 28 days) from hospitalization
Number of days safe from ventilators
Time Frame: during hospital admission (up to 28 days)
efficacy of CSA in reducing days of ventilators
during hospital admission (up to 28 days)
Number of days on mechanical ventilation
Time Frame: during hospital admission (up to 28 days)
to evaluate the efficacy of CSA in reducing days of ventilators
during hospital admission (up to 28 days)
Number of days in the intensive care unit after randomization
Time Frame: during hospital admission (up to 28 days)]
to evaluate the efficacy of CSA in reducing days in the intensive care unit
during hospital admission (up to 28 days)]
Incidence of (Adverse Events) and Incidence of nosocomial bacterial or invasive fungal infection
Time Frame: during hospital admission (up to 28 days)]
to evaluate the safety of CSA
during hospital admission (up to 28 days)]
Mean change of SOFA score in ICU patients
Time Frame: between 1, 15 days) hospital discharge
The Sequential Organ Failure Assessment (SOFA) score: 0 (best) - 24 (worse) The SOFA score will be used to assess the probability of organ failure and mortality in ICU patients
between 1, 15 days) hospital discharge
Mean improvement in Clinical Deterioration Changed Early Warning Score (MEWS) between 1, 15 days)
Time Frame: between 1, 15 days) hospital discharge
efficacy of CsA in Clinical improvement
between 1, 15 days) hospital discharge
rate of Mortality
Time Frame: throughout 30 and 90 days
efficacy of CsA in reducing mortality
throughout 30 and 90 days
all-cause mortality will be measured.
Time Frame: At 28, 30, and 90 days,
efficacy of CsA in reducing mortality
At 28, 30, and 90 days,
Duration of hospital admission
Time Frame: through study completion, an average of 4 weeks
efficacy of CsA (cyclosporine) in reducing days in hospital
through study completion, an average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Maged El-Setouhy, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Actual)

September 9, 2022

Study Completion (Actual)

December 9, 2022

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 24, 2023

Last Verified

July 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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