RegCOVID19: Observational Study of Follow-up of Hospitalized Patients Diagnosed With COVID-19 to Evaluate the Effectiveness of the Drug Treatment Used to Treat This Disease. COVID-19 Registry

Sponsor

Instituto de Investigación Marqués de Valdecilla (Other)

Overall Status

Recruiting

CT.gov ID

NCT04347278

Collaborator

Hospital Universitario Marqués de Valdecilla (Other), Hospital Universitario de Canarias (Other), Hospital San Pedro de Alcantara (Other)

1,000

Enrollment

Location

20.3

Anticipated Duration (Months)

49.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Drug: Patients with the treatment agains COVID19

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Observational Study of Follow-up of Hospitalized Patients Diagnosed With COVID-19 to Evaluate the Effectiveness of the Drug Treatment Used to Treat This Disease. COVID-19 Registry

Actual Study Start Date :

Apr 22, 2020

Anticipated Primary Completion Date :

Oct 15, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients receiving treatment for COVID19	Drug: Patients with the treatment agains COVID19 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.

Arm

Intervention/Treatment

Patients receiving treatment for COVID19

Drug: Patients with the treatment agains COVID19

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.

Outcome Measures

Primary Outcome Measures

Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice [6 months]
Measured in terms of clinical recovery

Secondary Outcome Measures

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]
to know the use according to the Ministry of Health Technical Document
Adverse events [6 months]
Adverse effects of the medicines used
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]
Determine the evolution of the treatments
healthy survey for patients after their recovery/discharge from hospital. [6 months]
It is composed of 10 items, with scores from 0 (worst health) to 100 points (best health)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria	Spain	39008

Sponsors and Collaborators

Instituto de Investigación Marqués de Valdecilla
Hospital Universitario Marqués de Valdecilla
Hospital Universitario de Canarias
Hospital San Pedro de Alcantara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Investigación Marqués de Valdecilla

ClinicalTrials.gov Identifier:

NCT04347278

Other Study ID Numbers:

IDI-REM-2020-1

First Posted:

Apr 15, 2020

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Instituto de Investigación Marqués de Valdecilla

COVID19

ICU

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Sep 16, 2021