An observational study in Aging, SARS-CoV-2 Infection and Caregivers, sponsored by Gerencia de Atención Primaria, Madrid. Completed at 2 sites in Spain. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2025-09-03.
Sponsored by Gerencia de Atención Primaria, Madrid · Observational
Among 401 studies in COVID-19 with a site in Spain — 25 open to participants now, 32 under way, 7 of them phase 3. COVID-19 · Spain.
Among the 401 studies in COVID-19 with a site in Spain, this one is the 50th largest by enrollment of the 146 observational ones that give a count, is one of 48 that started in 2022, is one of 146 observational ones, and was the 301st registered.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
Browse COVID-19 studies →25 of the 401 studies in COVID-19 with a site in Spain are open now. Recruiting first, the newest first:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Sites in Spain
Pfizer · Sites in Spain, United States, Argentina and 15 more countries
Pfizer · Sites in Spain, United States, Argentina and 16 more countries
Merck Sharp & Dohme LLC · Sites in Spain, United States, Argentina and 21 more countries
PEACHES BIOTECH · Sites in Spain
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 356 COVID-19 studies recruiting now, 207 (58%) set no upper age limit and 83 (23%) stop at 75 or younger; 91 take children under 18; 136 take healthy volunteers.
This study: 75 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
401 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 11 · Phase 2 84 · Phase 3 90 · Phase 4 14
First in 2015; this study’s year is marked. 48 started in 2022.
This study's enrollment of 1,035 is above the median of 268 across 3,208 observational studies indexed under COVID-19.
Median enrollment 132 across the 254 interventional studies, 600 across the 146 observational. Of the 287 that completed or were terminated, 73 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
107 of 401 have an industry lead sponsor. The 10 most frequent:
Gerencia de Atención Primaria, Madrid is the lead sponsor of 29 studies on the registry; 2 are open to participants now.
Gerencia de Atención Primaria, Madrid has 1 study filed under COVID-19 — fewer than ten, so there is no comparison to draw.
8 of the studies in COVID-19 with a site in Spain that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07013474Phase 3PfizerA Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised | 2027-09-28 |
| NCT06679140Phase 3PfizerA Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease | 2027-10-01 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT06544395Clinica Gema LeonEfficacy of Non-invasive Neuromodulation Treatments for COVID-19 Sequelae | 2026-12-01 |
| NCT07197164Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaSafety and Effectiveness of a Remdesivir Treatment to Prevent Severe COVID-19 in Kidney Transplant Patients | 2026-12-30 |
Among the 401 studies in COVID-19 with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The measures to control the transmissibility of the Covid-19 pandemic have changed the daily routines of the population, increasing sedentary lifestyles, decreasing outdoor physical activity and limiting contact with neighbors, family and friends. This could be having negative consequences for the health of vulnerable people.
The investigators want to know how this situation has affected the health of people aged 75 years or older and their caregivers and how the circumstances experienced may mark new care needs.
To this end, will be analyzed clinical data, follow up people who have become ill with COVID-19 and those who have not, and interview groups of caregivers and patients to hear about the personal impact of the pandemic on them.
This will allow us to explore what changes are needed in health care to achieve an improvement in the health and quality of life of this population.
CUIDAMOS+75 seeks the commitment of the population and of the different people in charge of the health services from the very beginning.
Objective:
To explore the impact of the pandemic SARS-CoV-2 on the state of health of people aged ≥75 years.
Design:
Mixed-methods study. 1) Multipurpose, ambispective, longitudinal population-based cohort study with real world data and 6 years of follow-up; 2) Prospective observational cohort study with 18 months of follow-up; 3) Qualitative study with a critical-social approach. Scope:
Primary care in 11 Autonomous Regions.
Population:
People aged ≥75 years, attending healthcare centres in the study area.
Sample:
The population cohort will include the total population that meets the criteria, out of the estimated 1619620. The prospective cohort size is 1035, recruited on a probabilistic basis by clinical nurses. In the social critical approach the selection will be intentional and will progress towards theoretical sampling according to the emerging findings.
V. outcome:
Population-based cohort: nursing diagnostic and interventions and use of services; mortality, quality of life (EQ-5D) and functional capacity (Barthel) for cohort follow-up.
V. exposure:
SARS-CoV-2 infection.
Sources:
Clinical history, clinical interview, semi-structured interviews and focus groups.
Analysis:
Population cohort: to explore the evolution of diagnostic and interventions, a time series analysis will be carried out. Cohort study: Kaplan-Meier survival curves for mortality, functional change and quality of life. Cox proportional hazards models will be used to study the impact of infection on the three variables at 6, 12 and 18 months, adjusted for socio-demographic and clinical variables. Qualitative study: thematic, semiotic and discursive positions analysis.
Persons ≥75 years of age registered at the health centres in the study area. A total population of 1,619,620 users is estimated.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Confirmed SARS-CoV-2 infection diagnosed after 11 May 2020 and registered in electronic health records. (positive confirmatory test on nucleic acid amplification (rRT-PCR) or having had symptoms for \<5 days is positive on a PRAg test)
Other: Exposure SARS-CoV-2 Infection
No confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020.
The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Positive confirmatory test on nucleic acid amplification (rRT-PCR) or having had symptoms for \<5 days is positive on a PRAg test.
Changes caused by the SARS-CoV-2 pandemic in the use of health services in a population-based cohort of non-institutionalised people aged 75 years and older.
By analysing real-life data from electronic clinical records.
Time frame: up to 1 year
Changes from baseline prevalence of care needs of non-institutionalised people aged 75 and over in the context of the SARS-CoV-2 pandemic.
Sub-study 1: Longitudinal study of a population-based, multipurpose, ambispective cohort. Variables on nursing interventions will be collected through the primary care electronic medical record.
Time frame: at the basal time.
Changes from baseline prevalence of care needs of non-institutionalised people aged 75 and over in the context of the SARS-CoV-2 pandemic.
Sub-study 1: Longitudinal study of a population-based, multipurpose, ambispective cohort. Variables on nursing interventions will be collected through the primary care electronic medical record.
Time frame: 6 years follow-up.
Number of participants with changes caused by the SARS-CoV-2 pandemic in the functional capacity of non-institutionalised people aged 75 and over.
Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change in functioning will be collected using the Barthel scale.
Time frame: 18 months follow-up
Number of participants with changes caused by the SARS-CoV-2 pandemic in the quality of life of non-institutionalised people aged 75 and over.
Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change quality of life will be collected using the EQ-5D.
Time frame: 18 months follow-up
Number of participants with changes caused by the SARS-CoV-2 pandemic in the cognitive capacity of non-institutionalised people aged 75 years and over.
Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on change cognitive capacity will be collected using the Mini Mental Status Examination.
Time frame: 18 months follow-up
Number of participants with changes caused by the SARS-CoV-2 pandemic in the mental health of non-institutionalised people aged 75 and over.
Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Data on mental health capacity will be collected using the Hamilton Scale.
Time frame: 18 months follow-up
Incidence of mortality caused by the SARS-CoV-2 pandemic among non-institutionalised persons aged 75 years and over.
Sub-study 2: Prospective observational cohort study with a follow-up of 18 months. The exposure variable is confirmed SARS-CoV-2 infection with diagnosis after 11 May 2020. Mortality data shall be studied through medical records.
Time frame: 18 months follow-up
Understand and interpret the social, political and economic dimensions linked to the use of health services by people aged 75 and over and family caregivers during the pandemic and think about possible coping strategies.
Sub-study 3:Qualitative study with a social critical approach through semi-structured interviews for ≥75 years and focus groups for caregivers. A thematic analysis will be carried out, which will be complemented at the textual level by a semiotic analysis of discursive positions. In accordance with the critical character, discourse will be analysed as a reflection of ideological positions of inequality and domination.
Time frame: zero time, baseline.
Ran from Jun 2022 to primary completion in Dec 2024, 30 months.
Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 30 months is above that.
Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Gerencia de Atención Primaria, Madrid