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

• Conditions: SARS-CoV-2
• Interventions: Drug: Patients with the treatment agains COVID19

• Registration Number: NCT04347278
• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-11
• Study First Posted: 2020-04-15
• Study Start: 2020-04-22
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-09
• Last Update Posted: 2021-09-16
• Primary Completion: 2021-10-15
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients receiving treatment for COVID19	Patients with the treatment agains COVID19	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication.	6 months
Adverse events	6 months	Adverse effects of the medicines used
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)
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
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

Trial Locations

Locations (1)

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain