Follow-up of Covid-19 Long Term Sequelae

NCT05097677 | Completed

• 1 other identifier: ORCHESTRA WP2
• Study Type: observational
• Target: 7,599
• Locations: 6 countries
• Sites: 7

Brief Summary

The protocol, in accordance with the objectives of ORCHESTRA project - Work Package 2, aims at investigating the characteristics and determinants of COVID-19 long-term sequelae. This goal will be reached through the harmonization of follow-up strategies across the participating cohorts to allow a standardized collection of data on COVID-19 long-term sequelae. The result will be a platform including a set of data and biomaterials from large scale international cohorts, that will be uniformly recorded, prospectively tracked and analysed. The ultimate goal will be that of providing evidence to contribute to the optimization and improvement of the management and prevention of COVID-19 sequelae. The follow-up will be organized in multiple levels of tests, according to the capability of each cohort, and will include questionnaires to collect demographic, epidemiological and clinical data, physical examination, radiological exams and biological sampling. The long-term follow-up will also allow the assessment of long-term immunological response to SARS-CoV-2 infection and its association to the vaccination and to different treatment strategies, including monoclonal antibodies.

Conditions

COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Bronchitis; COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Lower Respiratory Infection; Covid19; Corona Virus Infection; Coronavirus; Coronavirus Infections; SARS-CoV2 Infection; SARS-CoV-2 Acute Respiratory Disease; SARS-Associated Coronavirus; SARS Pneumonia; SARS (Severe Acute Respiratory Syndrome); SARS (Disease); Coronavirus Pneumonia; Coronavirus Disease 2019; Coronavirus Sars-Associated

Outcome Measures

Primary Outcomes (10)

• Clinical assessments of COVID-19 sequelae

  Type of COVID-19 sequelae

  18 months

• Laboratory assessments of COVID-19 sequelae

  laboratory values out of the normal ranges identified by each local laboratory

  18 months

• Radiological assessments of COVID-19 sequelae

  Radiological exams described as abnormal with new findings

  18 months

• Length of COVID-19 sequelae

  Days of persistence of COVID-19 sequelae

  18 months

• Association between SARS-CoV-2 variants and COVID-19 sequelae

  SARS-CoV-2 variants

  18 months

• Association between immunological patterns and COVID-19 sequelae

  Serological assays for virus specific neutralizing and non-neutralizing antibodies

  18 months

• COVID-19 reinfections

  Rate of COVID-19 reinfections

  18 months

• Patterns of intestinal microbiome after SARS-CoV-2 infection

  Metagenomic sequencing on rectal swabs/stools

  18 months

• Patterns of pulmonary microbiome after SARS-CoV-2 infection

  Metagenomic sequencing on NP swabs

  18 months

• Human and viral genetic markers related to disease severity

  Whole-genome sequencing or whole-exome sequencing followed by functional analysis of the most promising variants.

  18 months

Interventions

Not applicable (observational study) OTHER

Not applicable (observational study)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with any comorbidity with previous diagnosis of SARS-CoV-2 infection admitted to or treated as inpatients or outpatients in university and non-university hospitals or medical practices.

You may qualify if:

• Any comorbidity
• Laboratory confirmed SARS-CoV-2 infection by PCR diagnosis from nasopharynx, oropharynx, bronchoalveolar lavage, stool, or blood. Rapid tests are an acceptable alternative.
• Individuals (or attorney or deputy who has been authorized to make the decision for patients who lack capacity) consent to participate
• Individuals over 14 years of ages

You may not qualify if:

• Lack of consent to participate
• Lack of laboratory confirmed SARS-CoV-2 infection.
• Individuals under 14 years of ages

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• University of Bologna: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Universiteit Antwerpen: collaborator
• University of Sao Paulo: collaborator
• Barcelona Institute for Global Health: collaborator
• Fondation pour la Recherche Médicale: collaborator
• Andaluz Health Service: collaborator
• Charite University, Berlin, Germany: collaborator
• CINECA consorzio universitario italiano: collaborator
• University Medical Center Groningen: collaborator
• Hospital Universitario Virgen Macarena: collaborator

Study Sites (7)

University of Antwerp - Laboratory of Medical Microbiology

Antwerp, 2610, Belgium

Location

INSERM

Paris, 75013, France

Location

Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento

Verona, 37126, Italy

Location

UMCG, University of Groningen

Groningen, Netherland, 9713, Netherlands

Location

Fondation Congolaise pour la Recherche Médicale

Brazzaville, 2672, Republic of the Congo

Location

Hosp. Univ. Virgen Macarena / Universidad de Sevilla

Seville, 41009, Spain

Location

Related Publications (1)

• Gentilotti E, Gorska A, Tami A, Gusinow R, Mirandola M, Rodriguez Bano J, Palacios Baena ZR, Rossi E, Hasenauer J, Lopes-Rafegas I, Righi E, Caroccia N, Cataudella S, Pasquini Z, Osmo T, Del Piccolo L, Savoldi A, Kumar-Singh S, Mazzaferri F, Caponcello MG, de Boer G, Hara GL; ORCHESTRA Study Group; De Nardo P, Malhotra S, Canziani LM, Ghosn J, Florence AM, Lafhej N, van der Gun BTF, Giannella M, Laouenan C, Tacconelli E. Clinical phenotypes and quality of life to define post-COVID-19 syndrome: a cluster analysis of the multinational, prospective ORCHESTRA cohort. EClinicalMedicine. 2023 Jul 21;62:102107. doi: 10.1016/j.eclinm.2023.102107. eCollection 2023 Aug.

  PMID: 37654668 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

COVID-19 biological samples (including blood, naso-pharingeal swabs, urine, and stool) will be collected and stored in the biobank of each participating center according to local authority regulation.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome; Disease

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Evelina Tacconelli, Professor

  Universita di Verona

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: October 28, 2021
• Study Start: April 16, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

BE (1); RE (1); ES (1); FR (1); NL (1); IT (2)