Brief Summary

The present study is part of ORCHESTRA project, a three-year international research project aimed at tackling the coronavirus pandemic. ORCHESTRA provides an innovative approach to learn from the pandemic SARS-CoV-2 crisis, derive recommendations to further management of COVID-19 and be prepared for the possible future pandemic waves. The ORCHESTRA project aims to deliver sound scientific evidence for the prevention and treatment of the infections caused by SARS-CoV-2 assessing epidemiological, clinical, microbiological, and genotypic aspects of population, environment and socio-economic features. The project builds upon existing, and new largescale population cohorts in Europe (France, Germany, Spain, Italy, Belgium, Romania, Netherlands, Luxemburg, and Slovakia) and non-European countries (India, Perú, Ecuador, Colombia, Venezuela, Argentina, Brazil and Gabon) including SARS-CoV-2 infected and non-infected individuals of all ages and conditions. The primary aim of ORCHESTRA is the creation of a new pan European cohort applying homogenous protocols for data collection, data sharing, sampling, and follow-up, which can rapidly advance the knowledge on the control and management of the COVID-19. ORCHESTRA will include SARS-CoV-2-negative individuals and thereby enable a prospective follow-up and an analysis of vaccination response. The cohort will involve four different populations: general population, COVID-19 patients, fragile individuals (children, elderly, transplanted, oncological, HIV infected, and those with Parkinson disease), and health-care workers. Each of these "perpetual" cohorts can answer different research questions and vaccine strategies. Within the ORCHESTRA project, the Work Package 4 (WP4) will focus on the cohort of fragile patients including pregnant women/new-born, children, patients with HIV infection, patients with autoimmune disease, solid organ transplant recipients, patients with oncological and hematological diseases, patients with cystic fibrosis, patients with Parkinson Disease and rheumatological diseases from from 14 countries (5 European and 9 non-European countries), with approximately 20000 subjects.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

8,894

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started May 2021

Typical duration for all trials

Geographic Reach

7 countries

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

Study Start

First participant enrolled

May 24, 2021

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2021

Completed

3 months until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2023

Completed

1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed

Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

November 8, 2021

Last Update Submit

March 24, 2025

Conditions

SARS CoV 2 Infection Vaccination; Infection Breakthrough Infection

Keywords

Frail patients

Outcome Measures