Long COVID in Military Organisations (LoCoMo)

June 24, 2021 updated by: Patricia Schlagenhauf, University of Zurich
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8001
        • Epidemiology, Biostatistics and Prevention Institute at the University of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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.

Additional inclusion criteria solely for the voluntary spermiogram test:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Symptomatic
167 symptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020
Other: No intervention
No intervention
Asymptomatic
167 asymptomatic Swiss army recruits who tested positive for SARS-CoV-2 in 2020
Other: No intervention
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
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcomes from components of the test battery
Time Frame: One year
The test battery will detect anticipated sequelae in the following categories: general systemic, pulmonary, cardiac, male fertility, psychological, ophthalmological.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Labor Speiz
Swiss Armed Forces
Universitätsspital Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

June 24, 2021

First Posted (Actual)

June 28, 2021

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 24, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2021-00256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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