Covid19LoCoMoNCT04942249
Long COVID in Military Organisations
An observational study of Covid19, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- How many people
- 500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 May 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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.
- Additional inclusion criteria solely for the voluntary spermiogram test:
- Male
- No known abnormality of the reproductive system (e.g. Klinefelter-Syndrome)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Epidemiology, Biostatistics and Prevention Institute at the University of Zurich
Zurich, 8001
About this study
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.
Read the detailed description
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
- Covid19
- Being tested
- No intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic | 167 symptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020 Receives: Other: No intervention | |
| Asymptomatic | 167 asymptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020 Receives: 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) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (1)
Outcomes from components of the test battery
The test battery will detect anticipated sequelae in the following categories: general systemic, pulmonary, cardiac, male fertility, psychological, ophthalmological.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start20 May 2021
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Labor Speiz, Swiss Armed Forces, University Hospital, Zürich
- Responsible party
- Principal investigator, Patricia Schlagenhauf, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942249
- Sponsor's protocol ID
- 2021-00256
- Acronym
- LoCoMo
- Status last verified
- Jun 2021
- First submitted
- 24 Jun 2021
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32601577Banerjee 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.
PubMed 33271682Barker-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.
PubMed 32475821Battaglini 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.
PubMed 32903391Bielecki 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.
PubMed 32594121Carfi 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.
PubMed 32644129Chen 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.
PubMed 32421258Del 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.
PubMed 33031513Disser 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.
PubMed 32675661Deuel 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.
PubMed 36030795
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long COVID in Military Organisations
- ClinicalTrials.gov ID
- NCT04942249
- Acronym / sponsor ID
- LoCoMo / 2021-00256
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Labor Speiz, Swiss Armed Forces, University Hospital, Zürich
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Jun 2021 (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.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Symptomatic | – | Other: No intervention167 symptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020 |
| Asymptomatic | – | Other: No intervention167 asymptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020 |
| No evidence of infection | – | Other: No intervention167 Swiss army recruits with no evidence of infection (who also were tested for SARS-CoV-2 in 2020) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Asymptomatic, No evidence of infection, Symptomatic |
Primary outcome
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
Time frame: One year
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.
1 secondary outcome
Outcomes from components of the test battery
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Background: PubMed 32601577Azim 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.
- Background: PubMed 33271682Banerjee 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.
- Background: PubMed 32475821Barker-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.
- Background: PubMed 32903391Battaglini 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.
- Background: PubMed 32594121Bielecki 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.
- Background: PubMed 32644129Carfi 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.
- Background: PubMed 32421258Chen 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.
- Background: PubMed 33031513Del 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.
- Background: PubMed 32675661Disser 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.
- Derived from this study: PubMed 36030795Deuel 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04942249, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.