Long COVID in Military Organisations

NCT ID: NCT04942249

Last Updated: 2021-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2021-12-31

Brief Summary

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A prospective, longitudinal cohort study designed to follow-up on 500 Swiss military personnel who tested in 2020 for SARS-CoV-2 (regardless of whether positive or negative, but with a known test result). Participants are invited to undergo an intensive test battery to evaluate if they suffer COVID-19 sequelae. The testing will include evaluation of several body systems (cardio-vascular, pulmonary, neurological, ophthalmological, psychological and general) and male fertility in a voluntary subgroup. Immune markers and SARS-CoV-2 reinfection rates will also be evaluated. The study hypothesis is that SARS-CoV-2 infection causes a multi-system disease with sequelae detectable in a significant proportion of army recruits after infection with SARS-CoV-2.

Detailed Description

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During the COVID-19 pandemic, many members of the Swiss armed forces (SAF) contracted SARS-CoV-2. Up to one fifth may suffer from long-term sequelae, or so-called "Long COVID". The "LoCoMo" study is a prospective, longitudinal cohort study designed to follow-up on 500 tested recruits who tested either positive or negative while serving in the SAF in early 2020.

The aim of this research project is to evaluate long-term sequelae that may have occurred in members of the armed forces. By following up on those army recruits who tested positive and who were either symptomatic or asymptomatic and comparing them with those who test negative; symptoms and sequelae of the infection and impact on life quality can be tracked. The acquired data will also provide insights into the duration of immunity (or lack thereof) after symptomatic and asymptomatic infection and the kinetics of antibody decline in those who test positive. Furthermore, the study allows to follow-up on those army recruits who have confirmed positive tests for SARS-CoV-2 and to compare them to those who were negative. The data collected with this extensive test battery allows for a follow-up on a wide range of symptoms, estimated rates of re-infection as well as long- term sequelae after infection, including impact on ophthalmological function, on life quality and activities and impact on male fertility.

The results of the study can also be extrapolated to health-care workers and other young adults who constitute the backbone of the workforce. Because the proposed test battery is very broad and comprehensive it may also detect hitherto unknown, long-term sequelae, which might provide insight in the pathophysiology and general understanding of consequences of SARS-CoV-2 infection which is the basis to develop strategies to mitigate the sequelae. This study will provide essential knowledge on the multi-organ impact of COVID-19 in young persons in Switzerland.

Conditions

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Covid19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptomatic

167 symptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020

No intervention

Intervention Type OTHER

No intervention

Asymptomatic

167 asymptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020

No intervention

Intervention Type OTHER

No intervention

No evidence of infection

167 Swiss army recruits with no evidence of infection (who also were tested for SARS-CoV-2 in 2020)

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Army recruits and personnel who tested for SARS-CoV-2.
* Completion of a consent form.
* Willing to participate and to complete the testing day in Zürich.


* Male
* No known abnormality of the reproductive system (e.g. Klinefelter-Syndrome)

Exclusion Criteria

* Unwilling to provide consent. Unable to attend the testing day in Zurich.
* A narrow-angle glaucoma or sensitivity to a component of the Tropicamide eye drops is not an exclusion criterion, but the eye examination will be performed without pharmacological mydriasis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Labor Speiz

UNKNOWN

Sponsor Role collaborator

Swiss Armed Forces

OTHER

Sponsor Role collaborator

Universitatsspital Zurich

UNKNOWN

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Patricia Schlagenhauf

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Epidemiology, Biostatistics and Prevention Institute at the University of Zurich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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Azim D, Nasim S, Kumar S, Hussain A, Patel S. Neurological Consequences of 2019-nCoV Infection: A Comprehensive Literature Review. Cureus. 2020 Jun 24;12(6):e8790. doi: 10.7759/cureus.8790.

Reference Type BACKGROUND
PMID: 32601577 (View on PubMed)

Banerjee D, Viswanath B. Neuropsychiatric manifestations of COVID-19 and possible pathogenic mechanisms: Insights from other coronaviruses. Asian J Psychiatr. 2020 Dec;54:102350. doi: 10.1016/j.ajp.2020.102350. Epub 2020 Aug 12.

Reference Type BACKGROUND
PMID: 33271682 (View on PubMed)

Barker-Davies RM, O'Sullivan O, Senaratne KPP, Baker P, Cranley M, Dharm-Datta S, Ellis H, Goodall D, Gough M, Lewis S, Norman J, Papadopoulou T, Roscoe D, Sherwood D, Turner P, Walker T, Mistlin A, Phillip R, Nicol AM, Bennett AN, Bahadur S. The Stanford Hall consensus statement for post-COVID-19 rehabilitation. Br J Sports Med. 2020 Aug;54(16):949-959. doi: 10.1136/bjsports-2020-102596. Epub 2020 May 31.

Reference Type BACKGROUND
PMID: 32475821 (View on PubMed)

Battaglini D, Brunetti I, Anania P, Fiaschi P, Zona G, Ball L, Giacobbe DR, Vena A, Bassetti M, Patroniti N, Schenone A, Pelosi P, Rocco PRM, Robba C. Neurological Manifestations of Severe SARS-CoV-2 Infection: Potential Mechanisms and Implications of Individualized Mechanical Ventilation Settings. Front Neurol. 2020 Aug 12;11:845. doi: 10.3389/fneur.2020.00845. eCollection 2020.

Reference Type BACKGROUND
PMID: 32903391 (View on PubMed)

Bielecki M, Zust R, Siegrist D, Meyerhofer D, Crameri GAG, Stanga Z, Stettbacher A, Buehrer TW, Deuel JW. Social Distancing Alters the Clinical Course of COVID-19 in Young Adults: A Comparative Cohort Study. Clin Infect Dis. 2021 Feb 16;72(4):598-603. doi: 10.1093/cid/ciaa889.

Reference Type BACKGROUND
PMID: 32594121 (View on PubMed)

Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.

Reference Type BACKGROUND
PMID: 32644129 (View on PubMed)

Chen L, Deng C, Chen X, Zhang X, Chen B, Yu H, Qin Y, Xiao K, Zhang H, Sun X. Ocular manifestations and clinical characteristics of 535 cases of COVID-19 in Wuhan, China: a cross-sectional study. Acta Ophthalmol. 2020 Dec;98(8):e951-e959. doi: 10.1111/aos.14472. Epub 2020 May 18.

Reference Type BACKGROUND
PMID: 32421258 (View on PubMed)

Del Rio C, Collins LF, Malani P. Long-term Health Consequences of COVID-19. JAMA. 2020 Nov 3;324(17):1723-1724. doi: 10.1001/jama.2020.19719. No abstract available.

Reference Type BACKGROUND
PMID: 33031513 (View on PubMed)

Disser NP, De Micheli AJ, Schonk MM, Konnaris MA, Piacentini AN, Edon DL, Toresdahl BG, Rodeo SA, Casey EK, Mendias CL. Musculoskeletal Consequences of COVID-19. J Bone Joint Surg Am. 2020 Jul 15;102(14):1197-1204. doi: 10.2106/JBJS.20.00847.

Reference Type BACKGROUND
PMID: 32675661 (View on PubMed)

Deuel JW, Lauria E, Lovey T, Zweifel S, Meier MI, Zust R, Gultekin N, Stettbacher A, Schlagenhauf P. Persistence, prevalence, and polymorphism of sequelae after COVID-19 in unvaccinated, young adults of the Swiss Armed Forces: a longitudinal, cohort study (LoCoMo). Lancet Infect Dis. 2022 Dec;22(12):1694-1702. doi: 10.1016/S1473-3099(22)00449-2. Epub 2022 Aug 26.

Reference Type DERIVED
PMID: 36030795 (View on PubMed)

Other Identifiers

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2021-00256

Identifier Type: -

Identifier Source: org_study_id

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