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    Summary
    EudraCT Number:2020-003628-18
    Sponsor's Protocol Code Number:000000
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-09-07
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2020-003628-18
    A.3Full title of the trial
    Adalimumab in COVID-19 to present respiratory failure in community care (AVID-CC): A randomised controlled trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adalimumab for Coronavirus in Community Care
    A.3.2Name or abbreviated title of the trial where available
    AVID-CC study
    A.4.1Sponsor's protocol code number000000
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN33260034
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1256-3361
    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 SponsorUniversity of Oxford, Clinical Trials and Research Governance
    B.1.3.4CountryUnited Kingdom
    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 supportSandoz UK Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportWellcome Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointJoanna Black
    B.5.3 Address:
    B.5.3.1Street AddressOCTRU, Botnar Research Centre, Windmill Road
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7LF
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailoctrutrialshub@ndorms.ox.ac.uk
    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 Yes
    D.2.1.1.1Trade name Hyrimoz
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameHyrimoz
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdalimumab
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number160
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 No
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19
    E.1.1.1Medical condition in easily understood language
    Coronavirus
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10070255
    E.1.2Term Coronavirus test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is using Adalimumab up to 2 times in the first 14 days from randomisation compared to standard care, effective in preventing and/or reducing the severity of COVID-19 disease at 28 days post randomisation?
    E.2.2Secondary objectives of the trial
    What is the safety profile of using Adalimumab in those with COVID-19 disease?

    What impact(if any) does Adalimumab have on the clinical course of a COVID-19 infection?

    There are some further exploratory variables being researched in this trial - they are:
    Exploratory investigation of biomarkers from those in the trial
    Exploratory investigation of drug levels in the blood for those given Adalimumab
    Compare the benefit/risk of the two dosing regimens of Adalimumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible for the trial if all of the following are true:
    • Aged at ≥ 18 years
    • Confirmed SARS-CoV-2 infection based on a validated test
    • CRP >50 mg/L or Lymphopaenia (<1.5 x 109/L) or Neutrophilia (>7.5 x 109/L)
    • Oxygen saturation >93% on air (pulse oximeter)
    E.4Principal exclusion criteria
    The participant may not enter the trial if ANY of the following apply:
    • Subject is considered to be in their last few weeks of life prior to this acute illness
    • Clinical frailty score of 8 or 9 prior to this acute illness
    o Note that acute delirium is not an exclusion
    • History of haematopoietic stem cell transplant or solid organ transplant
    • Chronic Obstructive Pulmonary Disease on long term oxygen therapy
    o Subjects with FEV1 known to be <50% will also be excluded
    • Concomitant use of DMARDs (including csDMARDs, tsDMARDs and bDMARDs) or other immuno-suppressants
    • Previous malignancy and lymphoproliferative disorders (within the last 5 years) with the exception of stable prostate cancer and basal cell carcinoma
    • Current participation in another therapeutic interventional clinical study for COVID-19
    • De-myelinating disease
    • Known to be co-infected with Hepatitis B Virus, HIV
    • Severe hepatic impairment
    • Acute Kidney Injury Stage 3 (NHS England Acute Kidney Injury algorithm)
    • Patients with tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, fungal superinfection and opportunistic infections requiring treatment.
    • Moderate or severe heart failure (NYHA class III/IV)
    • Treatment with anti-TNF drug in past 180 days (9 half lives of the drug)
    • Pregnancy
    • Lactating females
    • Women of child bearing potential who are unwilling to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the study and 5 months afterwards.
    E.5 End points
    E.5.1Primary end point(s)
    To establish whether treatment with Adalimumab is associated with a lower rate of progression to severe disease as defined by severe illness, or critical illness, or death from any cause in community care patients with COVID-19, 28 days after randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after randomisation
    E.5.2Secondary end point(s)
    Safety of Adalimumab

    Assessment of the impact of treatment with Adalimumab on the clinical course of COVID-19 infection
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 120 days post randomisation
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    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 Yes
    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
    The end of trial is the point at which all samples have been analysed and all the data has been entered into the clinical database and queries resolved. The maximum recruitment target is 750 subjects ((375 per arm) and standard of care) but the study may be stopped for futility or safety on the basis of recommendation from the DSMC. The TSC may terminate the study in the event that the incidence of cases of COVID-19 drops to a point where recruitment becomes impractical.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days28
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 650
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A small amount of those in the trial may have dementia and not be able to consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state750
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 750
    F.4.2.2In the whole clinical trial 750
    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)
    There is no provision for the IMP after the study period. Note the IMP is being used to see if it impacts an acute infection.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation N/A
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-23
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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