SARS-CoV 2COM-COVIDNCT04378452
Assessment of the Psycho-social Impact of COVID-19 Outbreak
An observational study of SARS-CoV 2 and COVID-19, run by Fundació Institut Germans Trias i Pujol at 4 sites in Spain.
Trial summary
It has been shown in previous important outbreaks of infectious diseases that they have a huge impact on individuals and communities. The psychological effects of the illness itself and the traumatic experiences of loved ones are experienced by individuals and complete health systems. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV 2, COVID-19, Quality of Life
- What is being tested?
- COM-COVID anonimous survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 56,656 participants
- Where
- 4 sitesSpain
- Study dates
- 31 Mar 2020to 7 Apr 2021
- How long will I take part?
- 1 Month
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All people >16 years old willing to participate in the COM-COVID survey study during the COVID-19 outbreak (period March 2020-September 2020).
Who may be able to join
- age = or >16 years old
- accepting to participate in the project and filling in the survey questionnaire
Who cannot join
- age <16 years old
- non accepting to participate in the project and filling in the survey questionnaire
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Fundació Institut Germans Trias i Pujol
Badalona, Catalonia, 08916
Fundació Lluita contra la Sida (FLS, Fight AIDS Foundation)
Badalona, Catalonia, 08916
Anaxomics biotech
Barcelona, 08007
Fundació Privada per a la Recerca i la Docència Sant Joan de Déu
Esplugues de Llobregat
About this study
Official title: Assessment of the Psycho-social Impact of COVID-19 Outbreak (COM-COVID)
It has been shown in previous important outbreaks of infectious diseases that they have a huge impact on individuals and communities. The psychological effects of the illness itself and the traumatic experiences of loved ones are experienced by individuals and complete health systems. Added to this, the social ecosystem and family finances are also severely affected. After several months of the outbreak start and several weeks of quarantine and self-isolation, the emotional burden on the community has increased. Added to this, many of the confirmed cases are healthcare workers. In addition to the risk of infection, these front-line staff are exposed to high levels of stress and anxiety. This gets worse as the pressure on the health system increases, forcing them to deal with significant ethical issues.
To respond to all these issues, the research group led by Dr. Cris Vilaplana at the Germans Trias i Pujol Research Institute (IGTP), have launched a questionnaire to ask the public, including health professionals, how are they being affected by the pandemic, not only in relation to their health but in terms of their emotional wellbeing and their family finances. The project is an initiative of the SMA-TB consortium (IGTP and Anaxomics) to fight against COVID-19. The Fundació Lluita contra la SIDA is also collaborating in the project. The survey is based on questions related to depression, anxiety, stress, and post-traumatic stress disorder, which have already been used in other epidemic outbreaks and in disaster situations, but it also includes questions adapted to the current situation.
The survey (now available in 4 languages) has been designed to be shared using a snowball strategy, making possible for everybody to participate and collaborate. The results obtained will initially help us to better understand the impact of the outbreak of COVID-19 on the general wellbeing of the population and health workers so that we can go on to develop strategies in coordination those in charge of administrations in order to adapt policies to people's real needs. The results of the study will be published in a scientific article and will be publicly available.
Read the detailed description
In March 30, 2020, 78797 confirmed cases of SARS-CoV-2, 6528 deaths and 14709 recovered were reported in Spain[1]; 16157 cases and 1410 deaths recorded in Catalonia[2]. Case fatality (8%) is calculated on the registered cases, even if the actual mortality rate is uncertain as the total number of cases (including those undiagnosed and with mild symptoms) is unknown [3]. It is already a fact that there is local transmission of SARS-CoV-2 in the community. Everyone with a compatible respiratory condition is considered likely to be a case of SARS-CoV-2[4], despite that the etiological diagnosis cannot be made in this context of health emergency for all cases suspected, because of the lack of kits, personnel and saturation of the health system.
Other major outbreaks of infectious diseases as Ebola have demonstrated that there is an important impact on the individuals and the communities. Psychological effects of the disease itself as well as the traumatic experience on the beloved ones are seen at individual level. At community level, health services, social system and economic productivity are severely affected[5].
After 2 months weeks of first case reported in Spain and 2,5 weeks of the quarantine and self-isolation of the region of Catalonia, the emotional burden of the general community has increased. In previous studies in other countries in which the SARS-CoV-2 epidemics have precede ours, a non despicable impact on mental health and emotional burden has been reported as well as has been demonstrated in mass quarantines which have been implemented in other epidemics context [6-8]. Moreover, a certain level of anxiety has been reported as necessary to adopt recommended precautionary measures against infection outbreaks[9], and therefore to successfully implement public health interventions understanding the attitudes and measuring psychological impact on people should be mandatory.
On the other hand, in our setting by last report at 30th March 2020, 2600 of the confirmed cases in Catalonia are healthcare workers, representing the 16%. Besides their obvious increased risk of being infected, the healthcare workers facing the SARS-CoV-2 epidemics at frontline (emergency rooms, ICUs and other dept.) are put under a lot of stress and levels of anxiety. This is worse as the tension to the Health Systems increase, they needing to face important ethical dilemmas including triage of patients. Moreover, SARS epidemic proved not only that frontline healthcare workers suffered from chronic stress, but that this lasted at least for one year after the epidemics wave was over [10].
The aim of the present study is to assess the psychological and socio-economic impact of the COVID-19 epidemics, and we intend to do this on both the general population and the healthcare workers.
An anonymous online survey is been shared through social media networks (including telegram, whatsapp, twitter) in order to get as many responses as possible from individuals of >16 years old. For the healthcare workers subpopulation the questionnaire will be also be distributed via email, posters, institutional websites and other means deemed appropriate (in hospital or other healthcare settings). The anonymous online survey will include questions on sociodemographic data, physical symptoms in the past 14 days, socio-economic impact of the COVID-19 outbreak, psychological impact of the COVID-19 outbreak and mental health status (through questions related to depression, anxiety, stress and PSTD, which have been used in other studies). We will share the survey through social media using the snowball sampling. We will continuously share the survey in order to collect responses 6 months after the outbreak, to learn how much the impact of it can last.
The results obtained will allow us to:
- Understand more accurately the impact of the COVID-19 outbreak on general population wellbeing.
- Measuring the impact on the health-care workers subpopulation which is critical to cope outbreaks is important to design interventions for stress management and enchance infection-control measures and patient care.
The COM-COVID project is led by Dr. Cris Vilaplana (Institute for Health Science Research Germans Trias i Pujol (IGTP)). Dr. Vilaplana's team, mainly dedicated to the study of tuberculosis (https://unitatdetuberculosiexperimental.wordpress.com/), has been following a research line for the last 4 years measuring the quality of life of people in the context of infectious diseases so that they can study people suffering from them in a more holistic and humanistic way[11,12]. The project is an initiative of the SMA-TB consortium (https://www.smatb.eu/) (IGTP and Anaxomics) to fight against COVID-19. The Fundació Lluita contra la SIDA (https://www.flsida.org/en) is also collaborating in the project.
- Conditions
- SARS-CoV 2, COVID-19, Quality of Life, Mental Health Wellness 1, Social Distance, SARS (Disease)
- Being tested
- COM-COVID anonimous survey
- Keywords
- SARS-CoV-2, COVID-19, psycho-social impact, mental health, infectious diseases
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Disease, Psychological Well-Being, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COM-COVID anonimous surveyBehavioural
Anonimous e-survey administered to the general population by sharing it through social and mass media, including questions on sociodemographic data, physical symptoms in the past 14 days compatible with SARS-CoV-2 infection, socio-economic impact of the COVID-19 outbreak and psychological impact of the COVID-19 outbreak and mental health status.
| Study group | Role | What they receive |
|---|---|---|
| COM-COVID cohort | Individuals of >16 years old evaluated during the COVID-19 outbreak by an anonymous survey and willing to respond. Expected timeframe for the collection of completed surveys: March 31th, 2020-September 30th, 2020] Receives: Behavioral: COM-COVID anonimous survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological impact of the outbreak, total score
Psychological impact of the outbreak, total score will be measured by the sum of the depression questions score, the anxiety questions score, the stress questions score and the PSTD questions score. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Measured: Through study completion, an average of 1 year.
Psychological impact of the outbreak: depression questions score
The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Measured: Through study completion, an average of 1 year.
Psychological impact of the outbreak: anxiety questions score
The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Measured: Through study completion, an average of 1 year.
Psychological impact of the outbreak: stress questions score
The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Measured: Through study completion, an average of 1 year.
Psychological impact of the outbreak: PSTD questions score
The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 0-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Measured: Through study completion, an average of 1 year.
Descriptive statistics for the non-psychological questions
Percentages of response will be calculated according to the number of respondents per each response out of the total number of responses of each question. All results will be given according to the respondents being part of the whole cohort of respondents, according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported per gender, age, country and postal code.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start31 Mar 2020
- Primary completion22 Mar 2021
- Study completion7 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 56,656 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Fundació Institut Germans Trias i Pujol
- Sponsor type
- University, hospital or other
- Collaborators
- Anaxomics SL, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, Fundació Sant Joan de Déu
- Responsible party
- Sponsor
- Investigators
- Cris Vilaplana, MD, PhD, Principal investigator, Fundació Institut Germans Trias i Pujol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378452
- Sponsor's protocol ID
- COM-COVID
- Acronym
- COM-COVID
- Status last verified
- Jul 2023
- First submitted
- 15 Apr 2020
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Results and database could be available upon request.
Publications
Farres J, Ruiz JL, Mas JM, Arias L, Sarrias MR, Armengol C, Cardona PJ, Munoz-Moreno JA, Vilaplana M, Arranz B, Usall J, Serrano-Blanco A, Vilaplana C. Identification of the most vulnerable populations in the psychosocial sphere: a cross-sectional study conducted in Catalonia during the strict lockdown imposed against the COVID-19 pandemic. BMJ Open. 2021 Nov 26;11(11):e052140. doi: 10.1136/bmjopen-2021-052140.
PubMed 34836903
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Psycho-social Impact of COVID-19 Outbreak (COM-COVID)
- ClinicalTrials.gov ID
- NCT04378452
- Acronym / sponsor ID
- COM-COVID / COM-COVID
- Conditions
- SARS-CoV 2, COVID-19, Quality of Life, Mental Health Wellness 1, Social Distance, SARS (Disease)
- Keywords
- SARS-CoV-2, COVID-19, psycho-social impact, mental health, infectious diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56,656 participants (actual)
- Lead sponsor
- Fundació Institut Germans Trias i PujolUniversity, hospital or other
- Collaborators
- Anaxomics SL, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia, Fundació Sant Joan de Déu
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 7 Apr 2021 (actual)
- First posted
- 7 May 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.
It has been shown in previous important outbreaks of infectious diseases that they have a huge impact on individuals and communities. The psychological effects of the illness itself and the traumatic experiences of loved ones are experienced by individuals and complete health systems. Added to this, the social ecosystem and family finances are also severely affected. After several months of the outbreak start and several weeks of quarantine and self-isolation, the emotional burden on the community has increased. Added to this, many of the confirmed cases are healthcare workers. In addition to the risk of infection, these front-line staff are exposed to high levels of stress and anxiety. This gets worse as the pressure on the health system increases, forcing them to deal with significant ethical issues.
To respond to all these issues, the research group led by Dr. Cris Vilaplana at the Germans Trias i Pujol Research Institute (IGTP), have launched a questionnaire to ask the public, including health professionals, how are they being affected by the pandemic, not only in relation to their health but in terms of their emotional wellbeing and their family finances. The project is an initiative of the SMA-TB consortium (IGTP and Anaxomics) to fight against COVID-19. The Fundació Lluita contra la SIDA is also collaborating in the project. The survey is based on questions related to depression, anxiety, stress, and post-traumatic stress disorder, which have already been used in other epidemic outbreaks and in disaster situations, but it also includes questions adapted to the current situation.
The survey (now available in 4 languages) has been designed to be shared using a snowball strategy, making possible for everybody to participate and collaborate. The results obtained will initially help us to better understand the impact of the outbreak of COVID-19 on the general wellbeing of the population and health workers so that we can go on to develop strategies in coordination those in charge of administrations in order to adapt policies to people's real needs. The results of the study will be published in a scientific article and will be publicly available.
Detailed description
In March 30, 2020, 78797 confirmed cases of SARS-CoV-2, 6528 deaths and 14709 recovered were reported in Spain[1]; 16157 cases and 1410 deaths recorded in Catalonia[2]. Case fatality (8%) is calculated on the registered cases, even if the actual mortality rate is uncertain as the total number of cases (including those undiagnosed and with mild symptoms) is unknown [3]. It is already a fact that there is local transmission of SARS-CoV-2 in the community. Everyone with a compatible respiratory condition is considered likely to be a case of SARS-CoV-2[4], despite that the etiological diagnosis cannot be made in this context of health emergency for all cases suspected, because of the lack of kits, personnel and saturation of the health system.
Other major outbreaks of infectious diseases as Ebola have demonstrated that there is an important impact on the individuals and the communities. Psychological effects of the disease itself as well as the traumatic experience on the beloved ones are seen at individual level. At community level, health services, social system and economic productivity are severely affected[5].
After 2 months weeks of first case reported in Spain and 2,5 weeks of the quarantine and self-isolation of the region of Catalonia, the emotional burden of the general community has increased. In previous studies in other countries in which the SARS-CoV-2 epidemics have precede ours, a non despicable impact on mental health and emotional burden has been reported as well as has been demonstrated in mass quarantines which have been implemented in other epidemics context [6-8]. Moreover, a certain level of anxiety has been reported as necessary to adopt recommended precautionary measures against infection outbreaks[9], and therefore to successfully implement public health interventions understanding the attitudes and measuring psychological impact on people should be mandatory.
On the other hand, in our setting by last report at 30th March 2020, 2600 of the confirmed cases in Catalonia are healthcare workers, representing the 16%. Besides their obvious increased risk of being infected, the healthcare workers facing the SARS-CoV-2 epidemics at frontline (emergency rooms, ICUs and other dept.) are put under a lot of stress and levels of anxiety. This is worse as the tension to the Health Systems increase, they needing to face important ethical dilemmas including triage of patients. Moreover, SARS epidemic proved not only that frontline healthcare workers suffered from chronic stress, but that this lasted at least for one year after the epidemics wave was over [10].
The aim of the present study is to assess the psychological and socio-economic impact of the COVID-19 epidemics, and we intend to do this on both the general population and the healthcare workers.
An anonymous online survey is been shared through social media networks (including telegram, whatsapp, twitter) in order to get as many responses as possible from individuals of >16 years old. For the healthcare workers subpopulation the questionnaire will be also be distributed via email, posters, institutional websites and other means deemed appropriate (in hospital or other healthcare settings). The anonymous online survey will include questions on sociodemographic data, physical symptoms in the past 14 days, socio-economic impact of the COVID-19 outbreak, psychological impact of the COVID-19 outbreak and mental health status (through questions related to depression, anxiety, stress and PSTD, which have been used in other studies). We will share the survey through social media using the snowball sampling. We will continuously share the survey in order to collect responses 6 months after the outbreak, to learn how much the impact of it can last.
The results obtained will allow us to:
- Understand more accurately the impact of the COVID-19 outbreak on general population wellbeing.
- Measuring the impact on the health-care workers subpopulation which is critical to cope outbreaks is important to design interventions for stress management and enchance infection-control measures and patient care.
The COM-COVID project is led by Dr. Cris Vilaplana (Institute for Health Science Research Germans Trias i Pujol (IGTP)). Dr. Vilaplana's team, mainly dedicated to the study of tuberculosis (https://unitatdetuberculosiexperimental.wordpress.com/), has been following a research line for the last 4 years measuring the quality of life of people in the context of infectious diseases so that they can study people suffering from them in a more holistic and humanistic way[11,12]. The project is an initiative of the SMA-TB consortium (https://www.smatb.eu/) (IGTP and Anaxomics) to fight against COVID-19. The Fundació Lluita contra la SIDA (https://www.flsida.org/en) is also collaborating in the project.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COM-COVID cohort | – | Behavioral: COM-COVID anonimous surveyIndividuals of >16 years old evaluated during the COVID-19 outbreak by an anonymous survey and willing to respond. Expected timeframe for the collection of completed surveys: March 31th, 2020-September 30th, 2020] |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All people >16 years old willing to participate in the COM-COVID survey study during the COVID-19 outbreak (period March 2020-September 2020).
Key inclusion criteria (2 listed)
- age = or >16 years old
- accepting to participate in the project and filling in the survey questionnaire
Key exclusion criteria (2 listed)
- age <16 years old
- non accepting to participate in the project and filling in the survey questionnaire
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 |
|---|---|---|
| COM-COVID anonimous surveyAnonimous e-survey administered to the general population by sharing it through social and mass media, including questions on sociodemographic data, physical symptoms in the past 14 days compatible with SARS-CoV-2 infection, socio-economic impact of the COVID-19 outbreak and psychological impact of the COVID-19 outbreak and mental health status. | Behavioural | COM-COVID cohort |
Primary outcome
Psychological impact of the outbreak, total score
Time frame: Through study completion, an average of 1 year.
Psychological impact of the outbreak, total score will be measured by the sum of the depression questions score, the anxiety questions score, the stress questions score and the PSTD questions score. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Psychological impact of the outbreak: depression questions score
Time frame: Through study completion, an average of 1 year.
The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Psychological impact of the outbreak: anxiety questions score
Time frame: Through study completion, an average of 1 year.
The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Psychological impact of the outbreak: stress questions score
Time frame: Through study completion, an average of 1 year.
The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 1-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Psychological impact of the outbreak: PSTD questions score
Time frame: Through study completion, an average of 1 year.
The score will be calculated as the result of the sum of the points received per question, each question can be answered in a range of 0-4. The results will be given according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported minimum per gender, age, country and postal code.Results will be represented by week of survey completion, and reported related to relevant dates (weeks of confinement, major announcements to the whole population by their Governments, etc.)
Descriptive statistics for the non-psychological questions
Time frame: Through study completion, an average of 1 year.
Percentages of response will be calculated according to the number of respondents per each response out of the total number of responses of each question. All results will be given according to the respondents being part of the whole cohort of respondents, according to being part of general population and according to being part of the healthcare workers subpopulation. Responses will also be reported per gender, age, country and postal code.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Results publication: PubMed 34836903Farres J, Ruiz JL, Mas JM, Arias L, Sarrias MR, Armengol C, Cardona PJ, Munoz-Moreno JA, Vilaplana M, Arranz B, Usall J, Serrano-Blanco A, Vilaplana C. Identification of the most vulnerable populations in the psychosocial sphere: a cross-sectional study conducted in Catalonia during the strict lockdown imposed against the COVID-19 pandemic. BMJ Open. 2021 Nov 26;11(11):e052140. doi: 10.1136/bmjopen-2021-052140.
- COM-COVID project websiteLink provided by the sponsor.
- COM-COVID results -complete dataset results generatedLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Results and database could be available upon request.
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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.
Cris Vilaplana, MD, PhD principal investigator
Fundació Institut Germans Trias i Pujol
4 sites 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 and COVID-19, run by Fundació Institut Germans Trias i Pujol at 4 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological impact of the outbreak, total score (time frame: Through study completion, an average of 1 year.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04378452, which also lists 1 linked publication.
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 10 Jul 2023.