SARS-CoV-2RegCOVID19NCT04347278
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
An observational study of SARS-CoV-2, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- Patients with the treatment agains COVID19
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 22 Apr 2020to 1 Jan 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patients who do not wish to give informed consent once requested.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
MAR GARCIA
About this study
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.
- Conditions
- SARS-CoV-2
- Being tested
- Patients with the treatment agains COVID19
- Keywords
- COVID19, ICU
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving treatment for COVID19 | Not described Receives: Drug: Patients with the treatment agains COVID19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (6)
Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication.
Measured: 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
Measured: 6 months
Adverse events
Adverse effects of the medicines used
Measured: 6 months
Time of hospital admission and/or stay in ICU and maximum severity reached.
Measured: 6 months
Treatments for SARS-CoV-2 positive patients not described in the protocol
Determine the evolution of the treatments
Measured: 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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start22 Apr 2020
- Primary completion15 Oct 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Marqués de Valdecilla
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Marqués de Valdecilla, Hospital Universitario de Canarias, Hospital San Pedro de Alcantara
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347278
- Sponsor's protocol ID
- IDI-REM-2020-1
- Acronym
- RegCOVID19
- Status last verified
- Sep 2021
- First submitted
- 3 Apr 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04347278
- Acronym / sponsor ID
- RegCOVID19 / IDI-REM-2020-1
- Conditions
- SARS-CoV-2
- Keywords
- COVID19, ICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Instituto de Investigación Marqués de ValdecillaUniversity, hospital or other
- Collaborators
- Hospital Universitario Marqués de Valdecilla, Hospital Universitario de Canarias, Hospital San Pedro de Alcantara
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 15 Oct 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving treatment for COVID19 | – | Drug: Patients with the treatment agains COVID19 |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who do not wish to give informed consent once requested.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with the treatment agains COVID19Data 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. | Drug | Patients receiving treatment for COVID19 |
Primary outcome
Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice
Time frame: 6 months
Measured in terms of clinical recovery
6 secondary outcomes
Risk factors or modifiers of pharmacological effect such as demographic characteristics, comorbidity or underlying pathology, concomitant medication.
Time frame: 6 months
Information on the patterns of use of these drugs (dose, duration of treatment,
Time frame: 6 months
Adverse events
Time frame: 6 months
Time of hospital admission and/or stay in ICU and maximum severity reached.
Time frame: 6 months
Treatments for SARS-CoV-2 positive patients not described in the protocol
Time frame: 6 months
healthy survey for patients after their recovery/discharge from hospital.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by Instituto de Investigación Marqués de Valdecilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MARIA DEL MAR GARCIA SAIZ, MDPhD (942203333, mmar.garcia@scsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of current drug treatments for hospitalized patients with SARS-CoV-2 infection (COVID-19 patients) in routine clinical practice (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.