NCT04347278

Brief Summary

The infection caused by COVID19 worldwide makes it necessary to monitor drugs administered for the treatment of patients hospitalized with SARS-CoV-2. In order to know more about the efficacy and safety of the treatments used, researchers from the Cantabrian health service have developed an observational study, in the form of an ambispective registry, in which clinical data from patients treated with the different drugs currently recommended by the Spanish Agency of Medicines and Health Products (SAMHP) and the Ministry of Health, or others that may arise, are collected and analyzed. Although the conduct of clinical trials is a priority at this time, we cannot lose the clinical experience that is currently being generated, which may allow us to improve the therapeutic strategies for future patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 3, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

April 22, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

1.5 years

First QC Date

April 3, 2020

Last Update Submit

September 9, 2021

Conditions

SARS-CoV-2

Keywords

COVID19ICU

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice

    Measured in terms of clinical recovery

    6 months

Secondary Outcomes (6)

  • Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication.

    6 months

  • Information on the patterns of use of these drugs (dose, duration of treatment,

    6 months

  • Adverse events

    6 months

  • Time of hospital admission and/or stay in ICU and maximum severity reached.

    6 months

  • Treatments for SARS-CoV-2 positive patients not described in the protocol

    6 months

  • +1 more secondary outcomes

Study Arms (1)

Patients receiving treatment for COVID19

Drug: Patients with the treatment agains COVID19

Interventions

Patients with the treatment agains COVID19DRUG

Data will be collected from patients who receive any of the treatments included in the "Technical Document. Manejo clínico del COVID-19: tratamiento médico" of the Ministry of Health, and "Tratamientos disponibles para el manejo de la infección respiratoria por SARS-CoV-2" of the AEMPS, either as antivirals or as treatment of the inflammatory process in patients with SARS, or others as they arise.

Patients receiving treatment for COVID19

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subject of the study is any person diagnosed with COVID-19 who is admitted to a hospital either as an inpatient or in an intensive care unit (ICU).

You may qualify if:

  • Patients of any age and gender, including minors and pregnant women.
  • Hospital admission with diagnosis of COVID-19 according to clinical and microbiological criteria established by the Health Authorities and clinical practice (these may be modified based on the "Technical Document. Clinical management of COVID-19: hospital care" of the Ministry of Health).
  • Patients receiving any specific treatment for COVID-19 disease (according to the "Technical Document. Clinical management of COVID-19: medical treatment" of the Ministry of Health, and "Available treatments for the management of respiratory infection by SARS-CoV-2" of the AEMPS).
  • Patients admitted but not receiving specific treatment for COVID-19 disease

You may not qualify if:

  • Patients who do not wish to give informed consent once requested.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

MARIA DEL MAR GARCIA SAIZ, MDPhD

CONTACT

942203333mmar.garcia@scsalud.es

LUCIA LAVIN ALCONERO, Phd

CONTACT

942203373eclinicos5@idival.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 15, 2020

Study Start

April 22, 2020

Primary Completion

October 15, 2021

Study Completion

January 1, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)