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    Clinical Trial Results:
    EFFICACY OF CYCLOSPORINE A IN THE TREATMENT OF COVID-19 PNEUMONIA: A RANDOMIZED CONTROLLED TRIAL.

    Summary
    EudraCT number
    		 2020-002123-11
    Trial protocol
    		 ES  
    Global end of trial date
    21 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Aug 2025
    First version publication date
    16 Aug 2025
    Other versions
    Summary report(s)
    		 Cyclosporine A in hospitalized COVID‑19 pneumonia patients to prevent the development of interstitial lung disease: a pilot randomized clinical trial

    Trial information

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    Trial identification
    Sponsor protocol code
    HUIS-04-2020
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hospital Universitario Infanta Sofía
    Sponsor organisation address
    Paseo de Europa 34, Madrid, Spain, 28702
    Public contact
    Tatiana Cobo Ibáñez, Hospital Universitario Infanta Sofía, 34 911914037, mtatiana.cobo@salud.madrid.org
    Scientific contact
    Tatiana Cobo Ibáñez, Hospital Universitario Infanta Sofía, 34 911914037, mtatiana.cobo@salud.madrid.org
    Sponsor organisation name
    Hospital Universitario Infanta Sofía
    Sponsor organisation address
    Paseo de Europa 34, Madrid, Spain, 28702
    Public contact
    Gemma María Mora Ortega, Hospital Universitario Infanta Sofía, 34 911914061, gemma.moraor@salud.madrid.org
    Scientific contact
    Gemma María Mora Ortega, Hospital Universitario Infanta Sofía, 34 911914061, gemma.moraor@salud.madrid.org
    Sponsor organisation name
    Hospital Universitario Infanta Sofía
    Sponsor organisation address
    Paseo de Europa 34, Madrid, Spain, 28702
    Public contact
    Gonzalo Serralta San Martín, Hospital Universitario Infanta Sofía, 34 911914133, gonzalo.serralta@salud.madrid.org
    Scientific contact
    Gonzalo Serralta San Martín, Hospital Universitario Infanta Sofía, 34 911914133, gonzalo.serralta@salud.madrid.org
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of cyclosporine A (treatment group) versus non treatment (control group) in patients with acute COVID-19 pneumonia .
    Protection of trial subjects
    Yes. At each scheduled study visit on day 1, day 4, day 8, at discharge, day 30 and day 90, the detection of possible adverse events will be carried out through an interview with the patient, physical assessment and review of medical records including complementary tests. In addition, a telephone consultation will be carried out between the day of hospital discharge and day 30 (halfway between discharge and day 30), evaluating the patient's condition and possible adverse events.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 May 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    23
    From 65 to 84 years
    10
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From May 12, 2020 to May 15, 2021

    Pre-assignment
    Screening details
    		 Inclusion criteria: - Adult ≥ 18 years and <80 years - Very characteristic initial symptoms of SARS-CoV2 infection ≤ 7 days in duration - Presence of alveolar-interstitial lung infiltrates - Basal oxygen saturation <95% - Hospitalization - Patient status ≥ 3 according to the WHO clinical improvement ordinal scale - Positivity SAR-CoV2 PCR

    Pre-assignment period milestones
    Number of subjects started
    		 33
    Number of subjects completed
    		 33

    Period 1
    Period 1 title
    Baseline period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control group
    Arm description
    		 NON TREATMENT ASSOCIATED TO STANDARD OF CARE OF THE COVID-19 PNEUMONIA.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment group
    Arm description
    		 CYCLOSPORINE A ASSOCIATED TO STANDARD OF CARE OF THE COVID-19 PNEUMONIA.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    CYCLOSPORINE A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    - Starting dose: <60 kg: 100 mg/day (50-0-50); 60-80 Kg: 150 mg/day (100-0-50), >80 kg: 200 mg/day (100-0-100) - After 48 hours, if well tolerated: <60 kg: 150 mg/day (100-0-50); 60-80 Kg: 200 mg/day (100-0-100); >80 kg: 300 mg/day (150-0-150) - Monitor every 48 hours with trough levels in a blood or plasma sample (12 hours after the night dose and prior to administration of the morning dose) until the therapeutic range of 100-250 ng/mL is reached. Depending on the levels, the dose may be increased or decreased by 50 mg/day up to a maximum of 5 mg/kg/day.

    Number of subjects in period 1
    		Control group Treatment group
    Started
    16
    17
    Completed
    11
    14
    Not completed
    5
    3
         Death
    5
    1
         Lost to follow-up
    -
    1
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 NON TREATMENT ASSOCIATED TO STANDARD OF CARE OF THE COVID-19 PNEUMONIA.

    Reporting group title
    Treatment group
    Reporting group description
    		 CYCLOSPORINE A ASSOCIATED TO STANDARD OF CARE OF THE COVID-19 PNEUMONIA.

    Reporting group values
    		 Control group Treatment group Total
    Number of subjects
    		 16 17 33
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    56.7 ± 11.8
    Units: years
        arithmetic mean (standard deviation)
    		 60.1 ( 11.0 ) 53.6 ( 12.1 ) -
    Gender categorical
    Female sex
    Units: Subjects
        Female
    		 6 5 11
        Male
    		 10 12 22
    Subject analysis sets

    Subject analysis set title
    The full analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The full analysis set included all randomized patients who received at least one dose of treatment.

    Subject analysis sets values
    		 The full analysis set
    Number of subjects
    33
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    56.7 ± 11.8
    Units: years
        arithmetic mean (standard deviation)
    56.7 ( 11.8 )
    Gender categorical
    Female sex
    Units: Subjects
        Female
    11
        Male
    22

    End points

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    End points reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 NON TREATMENT ASSOCIATED TO STANDARD OF CARE OF THE COVID-19 PNEUMONIA.

    Reporting group title
    Treatment group
    Reporting group description
    		 CYCLOSPORINE A ASSOCIATED TO STANDARD OF CARE OF THE COVID-19 PNEUMONIA.

    Subject analysis set title
    The full analysis set
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The full analysis set included all randomized patients who received at least one dose of treatment.

    Primary: Complete response:

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    End point title
    		 Complete response:
    End point description
    The percentage of living patients who had not developed interstitial lung disease and did not require invasive mechanical ventilation (IMV) with orotracheal intubation (IOT) 3 months after the diagnosis of COVID-19 pneumonia.
    End point type
    Primary
    End point timeframe
    3 months
    End point values
    		 Control group Treatment group
    Number of subjects analysed
    16
    17
    Units: Percentage
        number (confidence interval 95%)
    50 (25.5 to 74.5)
    76.5 (56.3 to 96.7)
    Statistical analysis title
    		 Rate comparison
    Comparison groups
    Treatment group v Control group
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Partial response

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    End point title
    		 Partial response
    End point description
    The percentage of living patients who did not develop interstitial lung disease and required invasive mechanical ventilation (IMV) with orotracheal intubation (IOT) 3 months after the diagnosis of COVID-19 pneumonia
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Control group Treatment group
    Number of subjects analysed
    16
    17
    Units: Percentage
        number (confidence interval 95%)
    0 (0 to 0)
    5.9 (0 to 17.1)
    No statistical analyses for this end point

    Secondary: Complete plus partial response

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    End point title
    		 Complete plus partial response
    End point description
    The percentage of living patients who did not develop interstitial lung disease and required or did not require invasive mechanical ventilation (IMV) with orotracheal intubation (IOT) 3 months after the diagnosis of COVID-19 pneumonia.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Control group Treatment group
    Number of subjects analysed
    16
    17
    Units: Percentage
        number (confidence interval 95%)
    50 (25.5 to 74.5)
    82.4 (64.3 to 100)
    No statistical analyses for this end point

    Secondary: Not response due to difuse interstitial lung disease

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    End point title
    		 Not response due to difuse interstitial lung disease
    End point description
    Rate of patients who developing of diffuse interstitial lung disease 3 months after the diagnosis of COVID-19 pneumonia.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Control group Treatment group
    Number of subjects analysed
    11
    16
    Units: percentage
        number (confidence interval 95%)
    27.3 (5.5 to 49.1)
    12.5 (0 to 28.2)
    No statistical analyses for this end point

    Secondary: Not response due to death

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    End point title
    		 Not response due to death
    End point description
    Rate of patients who died 3 months after the diagnosis of COVID-19 pneumonia
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Control group Treatment group
    Number of subjects analysed
    16
    17
    Units: Percentage
        number (confidence interval 95%)
    31.3 (8.4 to 53.8)
    5.9 (0 to 17.1)
    No statistical analyses for this end point

    Secondary: Invasive mechanical ventilation (IMV)

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    End point title
    		 Invasive mechanical ventilation (IMV)
    End point description
    Rate of patients receiving invasive mechanical ventilation (IMV) with orotracheal intubation (OTI) 3 months after the diagnosis of COVID-19 pneumonia.
    End point type
    Secondary
    End point timeframe
    3 moths
    End point values
    		 Control group Treatment group
    Number of subjects analysed
    16
    17
    Units: Percentage
        number (confidence interval 95%)
    37.5 (13.8 to 61.2)
    11.8 (0 to 27.1)
    No statistical analyses for this end point

    Secondary: Rescue treatment with methylprednisolone

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    End point title
    		 Rescue treatment with methylprednisolone
    End point description
    Rate of patients requiring rescue treatment with methylprednisolone 3 months after the diagnosis of COVID-19 pneumonia.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Control group Treatment group
    Number of subjects analysed
    16
    17
    Units: Percentage
        number (confidence interval 95%)
    56.3 (32.0 to 80.6)
    52.9 (29.2 to 76.6)
    No statistical analyses for this end point

    Secondary: Rescue treatment with biological

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    End point title
    		 Rescue treatment with biological
    End point description
    Rate of patients requiring rescue treatment with biological therapy 3 months after the diagnosis of COVID-19 pneumonia.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Control group Treatment group
    Number of subjects analysed
    16
    17
    Units: Percentage
        number (confidence interval 95%)
    12.5 (0 to 28.7)
    17.6 (0 to 35.7)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    Control group
    Reporting group description
    		 NON TREATMENT ASSOCIATED TO STANDARD OF CARE OF THE COVID-19 PNEUMONIA.

    Reporting group title
    Treatment group
    Reporting group description
    		 CYCLOSPORINE A ASSOCIATED TO STANDARD OF CARE OF THE COVID-19 PNEUMONIA.

    Serious adverse events
    		 Control group Treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         number of deaths (all causes)
    5
    1
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control group Treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    2 / 17 (11.76%)
    Endocrine disorders
    hypoglycemia
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    Infections and infestations
    Pneumonia
    Additional description: nosocomial bacterial pneumonia
         subjects affected / exposed
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    Genital herpes
    Additional description: genital (type 2) herpes simplex infection
         subjects affected / exposed
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/38360855
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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