The Corona Study of Middle Norway

Study at a glance

From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

The Middle Norway Corona Study - Individual and Genetic Risk Factors for COVID-19 Infection.

ClinicalTrials.gov ID

NCT05638178

Acronym / sponsor ID

CUT COVID-19 / 121891

Conditions

SARS-CoV-2 Acute Respiratory Disease, SARS-CoV-2 Sepsis, SARS CoV 2 Infection

Study type

Observational

Recruitment status

Completed

Enrolment

223 participants (actual)

Lead sponsor

St. Olavs HospitalUniversity, hospital or other

Collaborators

The Research Council of Norway, Alesund Hospital, Namsos Hospital, Molde Hospital, Helse Nord-Trøndelag HF

Study start

1 May 2020 (actual)

Primary completion

31 Dec 2021 (actual)

Study completion

12 Aug 2022 (actual)

First posted

6 Dec 2022 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

2

Who may qualify

Sex

All

Healthy volunteers

Not accepted

Age groups

Child, Adult, Older adult

Study population

Population of Middle Norway Health Region

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Predictors of COVID-19 severity

   Time frame: 1 year after inclusion.

   Primary aim is to assess predictors of severe COVID disease in children and adults

Results and safety

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

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
• Background: PubMed 32966752Ponsford MJ, Gkatzionis A, Walker VM, Grant AJ, Wootton RE, Moore LSP, Fatumo S, Mason AM, Zuber V, Willer C, Rasheed H, Brumpton B, Hveem K, Kristian Damas J, Davies N, Asvold BO, Solligard E, Jones S, Burgess S, Rogne T, Gill D. Cardiometabolic Traits, Sepsis, and Severe COVID-19: A Mendelian Randomization Investigation. Circulation. 2020 Nov 3;142(18):1791-1793. doi: 10.1161/CIRCULATIONAHA.120.050753. Epub 2020 Sep 23. No abstract available.
• Background: PubMed 34237774COVID-19 Host Genetics Initiative. Mapping the human genetic architecture of COVID-19. Nature. 2021 Dec;600(7889):472-477. doi: 10.1038/s41586-021-03767-x. Epub 2021 Jul 8.
• Background: PubMed 35848942Degenhardt F, Ellinghaus D, Juzenas S, Lerga-Jaso J, Wendorff M, Maya-Miles D, Uellendahl-Werth F, ElAbd H, Ruhlemann MC, Arora J, Ozer O, Lenning OB, Myhre R, Vadla MS, Wacker EM, Wienbrandt L, Blandino Ortiz A, de Salazar A, Garrido Chercoles A, Palom A, Ruiz A, Garcia-Fernandez AE, Blanco-Grau A, Mantovani A, Zanella A, Holten AR, Mayer A, Bandera A, Cherubini A, Protti A, Aghemo A, Gerussi A, Ramirez A, Braun A, Nebel A, Barreira A, Lleo A, Teles A, Kildal AB, Biondi A, Caballero-Garralda A, Ganna A, Gori A, Gluck A, Lind A, Tanck A, Hinney A, Carreras Nolla A, Fracanzani AL, Peschuck A, Cavallero A, Dyrhol-Riise AM, Ruello A, Julia A, Muscatello A, Pesenti A, Voza A, Rando-Segura A, Solier A, Schmidt A, Cortes B, Mateos B, Nafria-Jimenez B, Schaefer B, Jensen B, Bellinghausen C, Maj C, Ferrando C, de la Horra C, Quereda C, Skurk C, Thibeault C, Scollo C, Herr C, Spinner CD, Gassner C, Lange C, Hu C, Paccapelo C, Lehmann C, Angelini C, Cappadona C, Azuure C; COVICAT study group, Aachen Study (COVAS); Bianco C, Cea C, Sancho C, Hoff DAL, Galimberti D, Prati D, Haschka D, Jimenez D, Pestana D, Toapanta D, Muniz-Diaz E, Azzolini E, Sandoval E, Binatti E, Scarpini E, Helbig ET, Casalone E, Urrechaga E, Paraboschi EM, Pontali E, Reverter E, Calderon EJ, Navas E, Solligard E, Contro E, Arana-Arri E, Aziz F, Garcia F, Garcia Sanchez F, Ceriotti F, Martinelli-Boneschi F, Peyvandi F, Kurth F, Blasi F, Malvestiti F, Medrano FJ, Mesonero F, Rodriguez-Frias F, Hanses F, Muller F, Hemmrich-Stanisak G, Bellani G, Grasselli G, Pezzoli G, Costantino G, Albano G, Cardamone G, Bellelli G, Citerio G, Foti G, Lamorte G, Matullo G, Baselli G, Kurihara H, Neb H, My I, Kurth I, Hernandez I, Pink I, de Rojas I, Galvan-Femenia I, Holter JC, Afset JE, Heyckendorf J, Kassens J, Damas JK, Rybniker J, Altmuller J, Ampuero J, Martin J, Erdmann J, Banales JM, Badia JR, Dopazo J, Schneider J, Bergan J, Barretina J, Walter J, Hernandez Quero J, Goikoetxea J, Delgado J, Guerrero JM, Fazaal J, Kraft J, Schroder J, Risnes K, Banasik K, Muller KE, Gaede KI, Garcia-Etxebarria K, Tonby K, Heggelund L, Izquierdo-Sanchez L, Bettini LR, Sumoy L, Sander LE, Lippert LJ, Terranova L, Nkambule L, Knopp L, Gustad LT, Garbarino L, Santoro L, Tellez L, Roade L, Ostadreza M, Intxausti M, Kogevinas M, Riveiro-Barciela M, Berger MM, Schaefer M, Niemi MEK, Gutierrez-Stampa MA, Carrabba M, Figuera Basso ME, Valsecchi MG, Hernandez-Tejero M, Vehreschild MJGT, Manunta M, Acosta-Herrera M, D'Angio M, Baldini M, Cazzaniga M, Grimsrud MM, Cornberg M, Nothen MM, Marquie M, Castoldi M, Cordioli M, Cecconi M, D'Amato M, Augustin M, Tomasi M, Boada M, Dreher M, Seilmaier MJ, Joannidis M, Wittig M, Mazzocco M, Ciccarelli M, Rodriguez-Gandia M, Bocciolone M, Miozzo M, Imaz Ayo N, Blay N, Chueca N, Montano N, Braun N, Ludwig N, Marx N, Martinez N; Norwegian SARS-CoV-2 Study group; Cornely OA, Witzke O, Palmieri O; Pa Study Group; Faverio P, Preatoni P, Bonfanti P, Omodei P, Tentorio P, Castro P, Rodrigues PM, Espana PP, Hoffmann P, Rosenstiel P, Schommers P, Suwalski P, de Pablo R, Ferrer R, Bals R, Gualtierotti R, Gallego-Duran R, Nieto R, Carpani R, Morilla R, Badalamenti S, Haider S, Ciesek S, May S, Bombace S, Marsal S, Pigazzini S, Klein S, Pelusi S, Wilfling S, Bosari S, Volland S, Brunak S, Raychaudhuri S, Schreiber S, Heilmann-Heimbach S, Aliberti S, Ripke S, Dudman S, Wesse T, Zheng T; STORM Study group, The Humanitas Task Force, The Humanitas Gavazzeni Task Force; Bahmer T, Eggermann T, Illig T, Brenner T, Pumarola T, Feldt T, Folseraas T, Gonzalez Cejudo T, Landmesser U, Protzer U, Hehr U, Rimoldi V, Monzani V, Skogen V, Keitel V, Kopfnagel V, Friaza V, Andrade V, Moreno V, Albrecht W, Peter W, Poller W, Farre X, Yi X, Wang X, Khodamoradi Y, Karadeniz Z, Latiano A, Goerg S, Bacher P, Koehler P, Tran F, Zoller H, Schulte EC, Heidecker B, Ludwig KU, Fernandez J, Romero-Gomez M, Albillos A, Invernizzi P, Buti M, Duga S, Bujanda L, Hov JR, Lenz TL, Asselta R, de Cid R, Valenti L, Karlsen TH, Caceres M, Franke A. Detailed stratified GWAS analysis for severe COVID-19 in four European populations. Hum Mol Genet. 2022 Nov 28;31(23):3945-3966. doi: 10.1093/hmg/ddac158.
• Official project page in the Norwegian research information systemLink provided by the sponsor.
• Individual participant dataSharing planned: Undecided. Will be decided on a case-by-case basis dependent on data protection impact assessment.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

5 sites in 1 country: see every site and its status.