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COVID-19 Acute Respiratory Distress SyndromePhase 3NCT04979884

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

A Phase 3 study testing cyclosporine in people with COVID-19 Acute Respiratory Distress Syndrome and Cytokine Release Syndrome, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
cyclosporine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteEgypt
Study dates
3 Jan 2022to 9 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.
  • -

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Alexandria university

    Alexandria, 21523

Other trials in Egypt

About this study

Official title: 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

Read the 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)
Being tested
cyclosporine
Keywords
COVID-19, Cyclosporine, secondary haemophagocytic lymphohistiocytosis (sHLH), acute respiratory distress syndrome (ARDS)
Medical subject headings
Cytokine Release Syndrome, Pulmonary Fibrosis, COVID-19, Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cyclosporineDrug

    Also called interleukin-2

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

Study groups in NCT04979884
Study groupRoleWhat they receive
cyclosporineExperimentalpatients will receive cyclosporine + (standard care treatment (± anticoagulant± antibiotic± antipyretic± steroid) according to Alexandria university hospitals protocol )
Receives: Drug: cyclosporine
Standard of care treatmentActive comparatorpatients will receive standard treatment (antiviral ± anticoagulant± antibiotic± antipyretic± steroid± interleukin ) according to Alexandria university hospitals protocol.
Receives: Drug: cyclosporine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    1. 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

    Measured: 7-14 days after randomization

Secondary outcomes (18)

  1. Duration of hospital admission

    efficacy of CsA (cyclosporine) in reducing days in hospital

    Measured: through study completion, an average of 4 weeks

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

    change from baseline in IL-2 levels

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

  3. Rate of decline OF interleukin-1

    change from baseline in IL-1 levels

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

  4. Rate of decline OF interleukin-10(IL-10)

    change from baseline in IL-10 levels

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

  5. Rate of decline OF Interleukin-6,( IL-6)

    change from baseline in IL-6levels

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

  6. Rate of decline OF Tumour necrosis factor α (TNFα)

    change from baseline in TNFα levels

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

  7. Time to 50% a decrease of ferritin levels compared to peak value during trial

    change from baseline in ferritin levels

    Measured: up to 28 days

  8. Lung imaging improvement time

    COVID19 Lung imaging determination

    Measured: up to 28 days

  9. Time for non-invasive or invasive initial use

    efficacy of CSA in reducing days of ventilators

    Measured: during hospital admission (up to 28 days)]

  10. Time to improvement in oxygenation

    defined as independence from supplemental oxygen

    Measured: up to 28 days) from hospitalization

  11. Number of days safe from ventilators

    efficacy of CSA in reducing days of ventilators

    Measured: during hospital admission (up to 28 days)

  12. Number of days on mechanical ventilation

    to evaluate the efficacy of CSA in reducing days of ventilators

    Measured: during hospital admission (up to 28 days)

  13. Number of days in the intensive care unit after randomization

    to evaluate the efficacy of CSA in reducing days in the intensive care unit

    Measured: during hospital admission (up to 28 days)]

  14. Incidence of (Adverse Events) and Incidence of nosocomial bacterial or invasive fungal infection

    to evaluate the safety of CSA

    Measured: during hospital admission (up to 28 days)]

  15. Mean change of SOFA score in ICU patients

    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

    Measured: between 1, 15 days) hospital discharge

  16. Mean improvement in Clinical Deterioration Changed Early Warning Score (MEWS) between 1, 15 days)

    efficacy of CsA in Clinical improvement

    Measured: between 1, 15 days) hospital discharge

  17. rate of Mortality

    efficacy of CsA in reducing mortality

    Measured: throughout 30 and 90 days

  18. all-cause mortality will be measured.

    efficacy of CsA in reducing mortality

    Measured: At 28, 30, and 90 days,

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start3 Jan 2022
  3. Primary completion9 Sep 2022
  4. Study completion9 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04979884
Sponsor's protocol ID
cyclosporine in COVID-19
Status last verified
Jul 2021
First submitted
14 Jul 2021
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31446206

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

    PubMed 8129618

  • 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.

    PubMed 19821520

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cyclosporine in people with COVID-19 Acute Respiratory Distress Syndrome and Cytokine Release Syndrome, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of subjects with a 6-point ordinal scale showing each severity level (time frame: 7-14 days after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04979884, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.

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