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 (RegCOVID19)

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.

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV-2
• Intervention / Treatment: Drug: Patients with the treatment agains COVID19

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: MARIA DEL MAR GARCIA SAIZ, MDPhD; Phone Number: 942203333; Email: mmar.garcia@scsalud.es
• Study Contact Backup: Name: LUCIA LAVIN ALCONERO, Phd; Phone Number: 942203373; Email: eclinicos5@idival.org

Study Locations

• Spain
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Recruiting
      • Hospital Universitario Marques de Valdecilla
      • Contact: MAR GARCIA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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,	to know the use according to the Ministry of Health Technical Document	6 months
Adverse events	Adverse effects of the medicines used	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	Determine the evolution of the treatments	6 months
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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Marqués de Valdecilla
• Collaborators: Hospital Universitario de Canarias; Hospital Universitario Marqués de Valdecilla; Hospital San Pedro de Alcantara

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Anticipated): October 15, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 11, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: ICU; COVID19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IDI-REM-2020-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No