Long COVID in Military Organisations

NCT04942249 | Unknown

• 1 other identifier: 2021-00256
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• to longitudinally follow-up on a cohort of 500 military who tested either positive or negative for SARS-CoV-2 in early 2020 for possible sequelae, one year post infection

  The primary endpoint is the occurrence of SARS-CoV-2 infection sequelae in a longitudinally follow-up cohort of a total of 500 military who tested either positive or negative for SARS-CoV-2 in early 2020.

  One year

Secondary Outcomes (1)

• Outcomes from components of the test battery

  One year

Study Arms (3)

Symptomatic

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

Other: No intervention

Asymptomatic

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

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)

Other: No intervention

Interventions

No intervention OTHER

No intervention

Asymptomatic; No evidence of infection; Symptomatic

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The project population is Swiss army recruits who were tested for SARS-CoV-2 in 2020 (regardless of whether they tested positive or negative, but with a known test result). The total number of participants is 500 stratified to 167 participants per infection status (symptomatic, asymptomatic or no evidence of infection).

You may qualify if:

• 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)

You may not qualify if:

• Unwilling to provide consent. Unable to attend the testing day in Zurich.

Sponsors & Collaborators

• University of Zurich: lead
• Labor Speiz: collaborator
• Swiss Armed Forces: collaborator
• Universitatsspital Zurich: collaborator

Study Sites (1)

Epidemiology, Biostatistics and Prevention Institute at the University of Zurich

Zurich, 8001, Switzerland

Location

Related Publications (10)

• 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.

  PMID: 32601577 BACKGROUND

• 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.

  PMID: 33271682 BACKGROUND

• 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.

  PMID: 32475821 BACKGROUND

• 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.

  PMID: 32903391 BACKGROUND

• 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.

  PMID: 32594121 BACKGROUND

• 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.

  PMID: 32644129 BACKGROUND

• 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.

  PMID: 32421258 BACKGROUND

• 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.

  PMID: 33031513 BACKGROUND

• 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.

  PMID: 32675661 BACKGROUND

• 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.

  PMID: 36030795 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and blood.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: June 24, 2021
• First Posted: June 28, 2021
• Study Start: May 20, 2021
• Primary Completion: October 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Locations

CH (1)