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

SARS-CoV-2 Clinical Trial

— RegCOVID19  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04347278
• Other study ID #: IDI-REM-2020-1
• Status: Recruiting
• Start date: April 22, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: September 2021
• Source: Instituto de Investigación Marqués de Valdecilla
• Contact: MARIA DEL MAR GARCIA SAIZ, MDPhD
• Phone: 942203333
• Email: mmar.garcia[@]scsalud.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria

Sponsors (4)

Lead Sponsor	Collaborator
Instituto de Investigación Marqués de Valdecilla	Hospital San Pedro de Alcantara, Hospital Universitario de Canarias, Hospital Universitario Marqués de Valdecilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication.		6 months
Secondary	Information on the patterns of use of these drugs (dose, duration of treatment,	to know the use according to the Ministry of Health Technical Document	6 months
Secondary	Adverse events	Adverse effects of the medicines used	6 months
Secondary	Time of hospital admission and/or stay in ICU and maximum severity reached.		6 months
Secondary	Treatments for SARS-CoV-2 positive patients not described in the protocol	Determine the evolution of the treatments	6 months
Secondary	healthy survey for patients after their recovery/discharge from hospital.	It is composed of 10 items, with scores from 0 (worst health) to 100 points (best health)	6 months