NCT04780373

Brief Summary

The aim of the study is to define the clinical and biochemical parameters that characterize COVID-19 patients with a negative prognostic evolution. Our clinical score will be capable to recognize patient with favorable prognosis or patient with poor prognosis by statistical data analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

January 22, 2021

Last Update Submit

April 27, 2021

Conditions

Covid19 Prognostic Parameters

Outcome Measures

Primary Outcomes (1)

  • Data collection of clinical and demographical parameters of patients affected by COVID-19

    Data about sex, age, symptom start date, vital parameters, comorbidity, symptoms, hematochemicals blood tests, therapy, oxygen support, radiology, condition evaluation will be manual collected.

    8 months

Secondary Outcomes (1)

  • Application of statistical analysis on data of patients affected by COVID-19

    2 months

Study Arms (2)

Development cohort

Other: data collection

Validation cohort

Other: data collection

Interventions

data collectionOTHER

clinical data collection

Development cohortValidation cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Italian Caucasian Patients ≥ 18 years old SARS-CoV-2 infection confirmed by PCR

You may qualify if:

  • patients over 18 and symptomatic and positive for COVID-19 by polymerase chain reaction assay for rhino-pharingeal swab

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of L'Aquila

L’Aquila, 67100, Italy

Location

Related Publications (1)

  • Sinatti G, Santini SJ, Tarantino G, Picchi G, Cosimini B, Ranfone F, Casano N, Zingaropoli MA, Iapadre N, Bianconi S, Armiento A, Carducci P, Ciardi MR, Mastroianni CM, Grimaldi A, Balsano C. PaO2/FiO2 ratio forecasts COVID-19 patients' outcome regardless of age: a cross-sectional, monocentric study. Intern Emerg Med. 2022 Apr;17(3):665-673. doi: 10.1007/s11739-021-02840-7. Epub 2021 Oct 12.

    PMID: 34637082DERIVED

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

January 22, 2021

First Posted

March 3, 2021

Study Start

April 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

IT(1)