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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2021-000781-15
    Sponsor's Protocol Code Number:COVFATI
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-01
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-000781-15
    A.3Full title of the trial
    Neuroinflammation and post-infectious fatigue in individuals with and without Covid-19
    Chronische vermoeidheidsklachten en neuro-inflammatie na een covid-19 infectie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Measuring neuro-inflammation in individuals with fatigue symptoms after a covid-19 infection
    A.3.2Name or abbreviated title of the trial where available
    COVFATI
    A.4.1Sponsor's protocol code numberCOVFATI
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmsterdam UMC VUmc
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportME/CVS stichting
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC VUmc
    B.5.2Functional name of contact pointdept. Radiology & Nuclear Medicine
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.6E-maile.coomans@amsterdamumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product name[18F]DPA-714
    D.3.4Pharmaceutical form Radiopharmaceutical precursor, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic fatigue after COVID-19 infection
    E.1.1.1Medical condition in easily understood language
    COVID-19
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to quantify neuroinflammation and whole-body inflammation with [18F]DPA-714 whole-body PET scans in post-COVID-19 infection
    E.2.2Secondary objectives of the trial
    To relate neuroinflammation and whole-body inflammation to cognitive, psychiatric and post-infectious fatigue symptoms.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1. In order to participate in this study, individuals with a previous COVID-19 infection and with post-infectious fatigue should meet the following criteria:
    1) The patient was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2, positive SARS-CoV-2 serology or CO-RADS (COVID-19 Reporting and Data System) 4 or 5 on CT-scan, or antigen quicktest, or had typical symptoms and was part of a household in which another person was tested positive by PCR 2 weeks before or after the first day of illness;
    2) The patient is 3 up to and including 16 months after being diagnosed with COVID-19 or after hospital discharge in case the patient was admitted.
    3) The patient experiences severe levels of fatigue (≥ 40) on the fatigue subscale of the Checklist Individual Strength [CIS-fatigue])9. The severe fatigue started with or increased substantially directly after the onset of symptoms of COVID-19;
    4) The patient reports physical/social disability (≤ 65 on the Rand36 physical functioning subscale or a score of ≥ 10 on the Work and Social Adjustment Scale [WSAS]10;
    5) The patient is in the range 40-60 years of age (to ensure radiation safety)
    6) The patient has sufficient command of the Dutch language
    7) Genotyping of rs6971 must show that patient is a mixed or high affinity binder

    Group 2. In order to participate in this study, individuals with a previous COVID-19 infection and without post-infectious fatigue should meet the following criteria:
    1) The patient was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2, positive SARS-CoV-2 serology or CO-RADS 4 or 5 on CT-scan, or antigen quicktest, or had typical symptoms and was part of a household in which another person was tested positive by PCR 2 weeks before or after the first day of illness;
    2) The patient is 3 up to and including 16 months after being diagnosed with COVID-19 or after hospital discharge in case the patient was admitted.
    3) The patient experiences no significant levels of fatigue (< 35 on the fatigue subscale of the Checklist Individual Strength [CIS-fatigue] and does not subjectively major symptoms of fatigue. Based upon average of normal population +1SD9
    4) The patient reports no physical/social disability (> 65 on the Rand36 physical functioning subscale or a score of < 10 on the Work and Social Adjustment Scale [WSAS]10;
    5) The patient is in the range 40-60 years of age (to ensure radiation safety)
    6) The patient has sufficient command of the Dutch language
    7) Genotyping of rs6971 must show that patient is a mixed or high affinity binder

    Group 3. Healthy controls should meet the following criteria:
    1) Should be negatively tested for COVID-19 trough PCR, serology, antibodies, or via antigen quicktest
    2) No evidence for substantial fatigue complaints as evidenced by the CIS subscale fatigue (<34) and does not subjectively major symptoms of fatigue. Based upon average of normal population +1SD9
    3) The patient is in the range 40-60 years of age (to ensure radiation safety)
    4) The patient has sufficient command of the Dutch language
    5) Genotyping of rs6971 must show that patient is a mixed or high affinity binder
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    1) Rs6971 shows low affinity binding
    2) Patients who are unable to lay still for scanning due to claustrophobia or severe back pain or trypanophobia (fear of needles)
    3) Gross neurological pathology (strategic or lobar infarcts or stroke or neurotrauma) on MRI or CT that may interfere with the interpretation of the PET scan.
    4) Have a hemoglobin test (Hb) result of < to 8 in males and < to 7 in females;
    5) Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum β-HCG at the time of screening and negative urine β-HCG within 24 hours prior to injection) or breastfeeding at screening.
    6) Have donated blood within 6 months prior to the [18F]DPA-714 PET scan day;
    7) The patient has an already known psychiatric or somatic condition that can explain
    his/her fatigue or major psychiatric disorder other than somatic-symptom disorder (chronic fatigue) as a main diagnosis. We will also screen for the presence of Post-Traumatic Stress Disorder PTSD as a main diagnosis] (PCL-5) which prevalence may be high in this patient group because of traumatic experiences during the acute phase of COVID-19. We will also screen for the presence of depressive disorder as a main diagnosis. To screen for PTSD and depressive disorder we will use the Diagnostic and Statistical Manual of Mental Disorders version 5 and verbally check if (any) symptoms do not meet the requirements for a PTSS or depression diagnostic/classification;
    8) Current use of benzodiazepines
    E.5 End points
    E.5.1Primary end point(s)
    Main study parameter/endpoint
    Differences in spatial-temporal TSPO binding capacity between 3 groups:
    1) Patients with post-infectious fatigue (of COVID-19 infection)
    2) Patients without post-infectious fatigue (of COVID-19 infection)
    3) Controls without evidence of COVID-19 and not severely fatigued.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After all participants have completed their study visits (2 visits per participant)
    E.5.2Secondary end point(s)
    Secondary study parameters/endpoints
    Correlation between TSPO binding capacity and degree of post-infectious fatigue and brain damage measured with MRI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After all participants have completed their study visits.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Pathophysiology
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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