COVID-19 Antibody Responses In Cystic Fibrosis

NCT04904445 | Completed

• 1 other identifier: NL
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is due to enhanced infection prevention practices or whether pwCF have protective genetic/immune factors. This study aims to prospectively assess the proportion of pwCF, including both adults and children with CF who have evidence of SARS-CoV-2 antibodies over a two-year period. This study will also examine whether pwCF who have antibodies for SARS-CoV-2 have a different clinical presentation and what impact this has on their CF disease. The proposed study will recruit pwCF from paediatric and adult CF centres throughout the United Kingdom. Serological testing to detect antibodies will be performed on blood samples taken at month 0, 6, 12, 18 and 24 with additional time-points if bloodwork is available via normal clinical care. Clinical data on, lung function, CF-related medical history, pulmonary exacerbations, antibiotic use, and microbiology and vaccination receipt, will be collected during routine clinical assessments. Associations will be examined between socio-demographic and clinical variables and serologic testing. The effects of SARS-CoV-2 infection on clinical outcomes and analyse end-points will be examined to explore any age-related or gender-based differences, as well as subgroup analysis of outcomes in lung-transplant recipients and pwCF receiving CFTR modulator therapies. As pwCF receive COVID-19 vaccination a comparison of the development and progression of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2 over time will be performed.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; COVID-19; SARS-CoV-2; Seroprevalence

Outcome Measures

Primary Outcomes (3)

• To evaluate SARS-CoV-2 seroprevalence

  proportion of pwCF with at least 1 seropositive result over the study period and the difference in this proportion by age, geographical area and over time.

  3-year period (comprising a 1-year enrollment period and a 2-year follow-up)

• To examine the associations

  Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF: incidence of symptomatic COVID-19 over the study period and severity; proportion of seropositive pwCF with subsequent CF exacerbation compared to pwCF who are seronegative; death rate in pwCF with at least one seropositive result compared to pwCF who are seronegative.

  3-year period (comprising a 1-year enrollment period and a 2-year follow-up)

• To perform a longitudinal comparison

  Longitudinal comparison of the detection including level and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and SARS-CoV-2 vaccination.

  3-year period (comprising a 1-year enrollment period and a 2-year follow-up)

Secondary Outcomes (1)

• Storage of samples for future analysis

  anticipated 5-10 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting people with cystic fibrosis of any age, genotype, transplant status and disease severity will be eligible to participate in the study. The study population is expected to be representative of the general CF population.

You may qualify if:

• Consenting people with cystic fibrosis of any age, genotype, transplant status and disease severity.

You may not qualify if:

• Refusal to give informed consent
• Contraindication to venepuncture.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Queen's University, Belfast: collaborator
• Cystic Fibrosis Foundation: collaborator
• European Cystic Fibrosis Society - Clinical Trials Network: collaborator

Study Sites (1)

Erasmus Medical Center Sophia Children's Hospital

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Related Publications (21)

• Abdollahi E, Champredon D, Langley JM, Galvani AP, Moghadas SM. Temporal estimates of case-fatality rate for COVID-19 outbreaks in Canada and the United States. CMAJ. 2020 Jun 22;192(25):E666-E670. doi: 10.1503/cmaj.200711. Epub 2020 May 22.

  PMID: 32444481 BACKGROUND

• Stadlbauer D, Amanat F, Chromikova V, Jiang K, Strohmeier S, Arunkumar GA, Tan J, Bhavsar D, Capuano C, Kirkpatrick E, Meade P, Brito RN, Teo C, McMahon M, Simon V, Krammer F. SARS-CoV-2 Seroconversion in Humans: A Detailed Protocol for a Serological Assay, Antigen Production, and Test Setup. Curr Protoc Microbiol. 2020 Jun;57(1):e100. doi: 10.1002/cpmc.100.

  PMID: 32302069 BACKGROUND

• Wolfel R, Corman VM, Guggemos W, Seilmaier M, Zange S, Muller MA, Niemeyer D, Jones TC, Vollmar P, Rothe C, Hoelscher M, Bleicker T, Brunink S, Schneider J, Ehmann R, Zwirglmaier K, Drosten C, Wendtner C. Virological assessment of hospitalized patients with COVID-2019. Nature. 2020 May;581(7809):465-469. doi: 10.1038/s41586-020-2196-x. Epub 2020 Apr 1.

  PMID: 32235945 BACKGROUND

• Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344.

  PMID: 32221519 BACKGROUND

• Chandrashekar A, Liu J, Martinot AJ, McMahan K, Mercado NB, Peter L, Tostanoski LH, Yu J, Maliga Z, Nekorchuk M, Busman-Sahay K, Terry M, Wrijil LM, Ducat S, Martinez DR, Atyeo C, Fischinger S, Burke JS, Slein MD, Pessaint L, Van Ry A, Greenhouse J, Taylor T, Blade K, Cook A, Finneyfrock B, Brown R, Teow E, Velasco J, Zahn R, Wegmann F, Abbink P, Bondzie EA, Dagotto G, Gebre MS, He X, Jacob-Dolan C, Kordana N, Li Z, Lifton MA, Mahrokhian SH, Maxfield LF, Nityanandam R, Nkolola JP, Schmidt AG, Miller AD, Baric RS, Alter G, Sorger PK, Estes JD, Andersen H, Lewis MG, Barouch DH. SARS-CoV-2 infection protects against rechallenge in rhesus macaques. Science. 2020 Aug 14;369(6505):812-817. doi: 10.1126/science.abc4776. Epub 2020 May 20.

  PMID: 32434946 BACKGROUND

• Petherick A. Developing antibody tests for SARS-CoV-2. Lancet. 2020 Apr 4;395(10230):1101-1102. doi: 10.1016/S0140-6736(20)30788-1. No abstract available.

  PMID: 32247384 BACKGROUND

• Wang S, Chou TH, Sakhatskyy PV, Huang S, Lawrence JM, Cao H, Huang X, Lu S. Identification of two neutralizing regions on the severe acute respiratory syndrome coronavirus spike glycoprotein produced from the mammalian expression system. J Virol. 2005 Feb;79(3):1906-10. doi: 10.1128/JVI.79.3.1906-1910.2005.

  PMID: 15650214 BACKGROUND

• He Y, Zhou Y, Siddiqui P, Jiang S. Inactivated SARS-CoV vaccine elicits high titers of spike protein-specific antibodies that block receptor binding and virus entry. Biochem Biophys Res Commun. 2004 Dec 10;325(2):445-52. doi: 10.1016/j.bbrc.2004.10.052.

  PMID: 15530413 BACKGROUND

• Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24.

  PMID: 31978945 BACKGROUND

• Coronaviridae Study Group of the International Committee on Taxonomy of Viruses. The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020 Apr;5(4):536-544. doi: 10.1038/s41564-020-0695-z. Epub 2020 Mar 2.

  PMID: 32123347 BACKGROUND

• Colombo C, Burgel PR, Gartner S, van Koningsbruggen-Rietschel S, Naehrlich L, Sermet-Gaudelus I, Southern KW. Impact of COVID-19 on people with cystic fibrosis. Lancet Respir Med. 2020 May;8(5):e35-e36. doi: 10.1016/S2213-2600(20)30177-6. Epub 2020 Apr 15. No abstract available.

  PMID: 32304639 BACKGROUND

• Cosgriff R, Ahern S, Bell SC, Brownlee K, Burgel PR, Byrnes C, Corvol H, Cheng SY, Elbert A, Faro A, Goss CH, Gulmans V, Marshall BC, McKone E, Middleton PG, Ruseckaite R, Stephenson AL, Carr SB; Global Registry Harmonization Group. A multinational report to characterise SARS-CoV-2 infection in people with cystic fibrosis. J Cyst Fibros. 2020 May;19(3):355-358. doi: 10.1016/j.jcf.2020.04.012. Epub 2020 Apr 25.

  PMID: 32376098 BACKGROUND

• Flight WG, Bright-Thomas RJ, Tilston P, Mutton KJ, Guiver M, Morris J, Webb AK, Jones AM. Incidence and clinical impact of respiratory viruses in adults with cystic fibrosis. Thorax. 2014 Mar;69(3):247-53. doi: 10.1136/thoraxjnl-2013-204000. Epub 2013 Oct 14.

  PMID: 24127019 BACKGROUND

• Wang EE, Prober CG, Manson B, Corey M, Levison H. Association of respiratory viral infections with pulmonary deterioration in patients with cystic fibrosis. N Engl J Med. 1984 Dec 27;311(26):1653-8. doi: 10.1056/NEJM198412273112602.

  PMID: 6504106 BACKGROUND

• Peckham D, McDermott MF, Savic S, Mehta A. COVID-19 meets Cystic Fibrosis: for better or worse? Genes Immun. 2020 Aug;21(4):260-262. doi: 10.1038/s41435-020-0103-y. Epub 2020 Jul 1.

  PMID: 32606316 BACKGROUND

• Wat D. Impact of respiratory viral infections on cystic fibrosis. Postgrad Med J. 2003 Apr;79(930):201-3. doi: 10.1136/pmj.79.930.201.

  PMID: 12743335 BACKGROUND

• Bucher J, Boelle PY, Hubert D, Lebourgeois M, Stremler N, Durieu I, Bremont F, Deneuville E, Delaisi B, Corvol H, Bassinet L, Grenet D, Remus N, Vodoff MV, Boussaud V, Troussier F, Leruez-Ville M, Treluyer JM, Launay O, Sermet-Gaudelus I. Lessons from a French collaborative case-control study in cystic fibrosis patients during the 2009 A/H1N1 influenza pandemy. BMC Infect Dis. 2016 Feb 1;16:55. doi: 10.1186/s12879-016-1352-2.

  PMID: 26830335 BACKGROUND

• Stanton BA, Hampton TH, Ashare A. SARS-CoV-2 (COVID-19) and cystic fibrosis. Am J Physiol Lung Cell Mol Physiol. 2020 Sep 1;319(3):L408-L415. doi: 10.1152/ajplung.00225.2020. Epub 2020 Jul 15.

  PMID: 32668165 BACKGROUND

• Berardis S, Verroken A, Vetillart A, Struyf C, Gilbert M, Gruson D, Gohy S. SARS-CoV-2 seroprevalence in a Belgian cohort of patients with cystic fibrosis. J Cyst Fibros. 2020 Nov;19(6):872-874. doi: 10.1016/j.jcf.2020.08.005. Epub 2020 Aug 11.

  PMID: 32828701 BACKGROUND

• Farrell PM, Rosenstein BJ, White TB, Accurso FJ, Castellani C, Cutting GR, Durie PR, Legrys VA, Massie J, Parad RB, Rock MJ, Campbell PW 3rd; Cystic Fibrosis Foundation. Guidelines for diagnosis of cystic fibrosis in newborns through older adults: Cystic Fibrosis Foundation consensus report. J Pediatr. 2008 Aug;153(2):S4-S14. doi: 10.1016/j.jpeds.2008.05.005.

  PMID: 18639722 BACKGROUND

• Howie SR. Blood sample volumes in child health research: review of safe limits. Bull World Health Organ. 2011 Jan 1;89(1):46-53. doi: 10.2471/BLT.10.080010. Epub 2010 Sep 10.

  PMID: 21346890 BACKGROUND

Related Links

• European Centre for Disease Prevention and Control. Immune responses and immunity to SARS-CoV-2. Published 2020.

Biospecimen

Retention: SAMPLES WITH DNA

A 6-monthly blood sample will be collected when the participants attend clinic or hospital. For participants who consent to the optional study, a second blood sample will also be drawn.

MeSH Terms

Conditions

Cystic Fibrosis; COVID-19

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Damian Downey, Dr

  Queen's University, Belfast

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Pulmonologist

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: May 21, 2021
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)