COVID-19 Survival - The COVIVA Study

NCT04366765 | Completed

• 1 other identifier: UHospital Switz
• Study Type: observational
• Target: 1,325
• Locations: 1 country
• Sites: 1

Brief Summary

The COVID-19 pandemic poses a major and imminent challenge for health care systems regarding patient triage and allocation of limited resources worldwide. The involved pathogenetic mechanisms as well as the clinical value of established and emerging biomarkers for early risk prediction are largely unknown. To fill these gaps in knowledge, investigators designed the prospective, interdisciplinary, observational, case-control "COronaVIrus surviVAl (COVIVA)" study platform, aiming to deliver an open-source platform to i) perform extensive clinical and biomarker phenotyping in COVID-19 suspects presenting to the emergency department (ED) as well as admitted to the intensive care unit, ii) compare clinical and biomarker profiles of COVID-19 patients with a control group, iii) derive and validate personalized risk prediction models for early clinical decision support, and iv) explore pathophysiological mechanisms including but not limited to inflammatory, immunological and cardiovascular pathways. Blood samples (serum) are routinely collected for bio banking both in cases and controls. Patients are followed 30 days after discharge. Personalized risk prediction models will be derived and validated based on advanced statistical models including machine-based learning incorporating a variety of clinical parameters and biomarker signatures (including digitally stored in-hospital data, e.g. imaging, ECG, ventilation parameters). Close cooperation with multiple other national and international COVID-19 cohorts is endorsed. The personalized risk prediction models from the COVIVA study will support clinicians in the most challenging process of limited resource allocation in a timely fashion. In addition, pathophysiological mechanisms and differences in mild and severe variants of COVID-19 as well as in the control group can be extensively studied in a multidisciplinary approach.

Conditions

COVID-19; SARS-CoV 2

Keywords

precision medicine; risk prediction; pathomechanisms; renin-angiotensin-aldosterone system (RAAS); biomarkers; biobank; serum; resource allocation; artificial intelligence; big data

Outcome Measures

Primary Outcomes (1)

• short-term prognosis

  incidence of death during index hospital stay

  at 30 days

Secondary Outcomes (10)

• Admission to the intensive care unit (ICU)

  at 30 days

• Invasive ventilation (Intubation)

  at 30 days

• Need for extracorporal membrane oxygenation (ECMO)

  at 30 days

• Hemodynamic support

  at 30 days

• Length of ICU stay

  at 30 days

Study Arms (1)

COVID-19 suspects

Patients presenting with suspected COVID-19 to the emergency department of the University Hospital Basel.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with clinical suspicion of COVID-19 or confirmed SARS-CoV2 infection triaged to the Emergency Department (ED) of the University Hospital Basel, Switzerland, are potentially eligible for enrolment in this study. An upstream pre-triage located outside the ED (in a nearby church) routinely performs clinical risk assessment in all patients with clinical suspicion of SARS-CoV-2 infection irrespective of symptoms severity and, if clinically indicated, nasopharyngeal swab testing. While patients with mild symptoms and in good clinical condition are assigned towards outpatient management, patients in poorer clinical conditions and higher likelihood of need for in-patient management are assigned to the ED, where they will be screened for potential COVIVA inclusion.

You may qualify if:

• Clinically suspected or confirmed SARS-CoV-2 infection triaged to the ED
• SARS-CoV-2 swab test performed (result may be pending at time of study enrolment)
• Age ≥18 years
• Patient or legally authorized representative is willing to sign local General consent form

You may not qualify if:

• Patient or legally authorized representative is unable or unwilling to participate in the study.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Serum sampling

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 Officials

• Raphael Twerenbold, MD

  Department of Cardiology and Cardiodiovascular Research Institute Basel (CRIB)

  PRINCIPAL INVESTIGATOR

• Gabriela Kuster Pfister, MD

  Department of Cardiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 29, 2020
• Study Start: March 19, 2020
• Primary Completion: January 5, 2021
• Study Completion: June 30, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)