COVID-19NCT07436494
Coronavirus Anxiety in Patients Using Biologic vs Conventional DMARDs
An observational study of COVID-19 and Anxiety, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The COVID-19 pandemic has caused significant psychological distress among patients with chronic diseases. Individuals receiving immunosuppressive therapies may experience increased anxiety due to perceived vulnerability to infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Anxiety, Rheumatic Diseases
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2020to 25 Jan 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with established rheumatic diseases under treatment with biologic or conventional DMARD therapy who were actively followed at a tertiary care rheumatology outpatient clinic during the COVID-19 pandemic.
Who may be able to join
- Age ≥18 years
- Diagnosis of rheumatic disease
- Currently receiving biologic or conventional disease-modifying antirheumatic drugs (DMARDs)
- Followed at the rheumatology outpatient clinic during the COVID-19 pandemic period
- Provided verbal informed consent
Who cannot join
- Age <18 years
- Inability to complete telephone interview
- Cognitive impairment preventing reliable questionnaire response
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Coronavirus-Related Anxiety Levels in Patients Using Biologic and Conventional Disease-Modifying Antirheumatic Drugs
The COVID-19 pandemic has caused significant psychological distress among patients with chronic diseases. Individuals receiving immunosuppressive therapies may experience increased anxiety due to perceived vulnerability to infection. This observational study aims to compare coronavirus-related anxiety levels in patients using biologic disease-modifying antirheumatic drugs (bDMARDs) and those using conventional disease-modifying antirheumatic drugs (cDMARDs).
Adult patients followed at the rheumatology outpatient clinic were contacted by telephone. After verbal consent was obtained, participants completed a patient information form and the Coronavirus Anxiety Scale. Anxiety levels and pandemic-related experiences were compared between treatment groups.
Read the detailed description
This observational cohort study was conducted at the Rheumatology outpatient clinic of Uludag University Faculty of Medicine. The study included adult patients diagnosed with rheumatic diseases who were receiving either biologic DMARDs (bDMARDs) or conventional DMARDs (cDMARDs).
During the COVID-19 pandemic period, patients were contacted by telephone and informed about the study. Verbal consent was obtained prior to data collection. Demographic and clinical characteristics were recorded using a structured patient information form.
Coronavirus-related anxiety was assessed using the validated Coronavirus Anxiety Scale. The primary objective was to compare anxiety scores between patients receiving biologic and conventional DMARD therapy. Secondary analyses explored patients' perceptions of infection risk and their experiences during the pandemic period.
No intervention, treatment modification, or additional clinical procedure was performed. The study design is observational, and all data were collected at a single time point.
- Conditions
- COVID-19, Anxiety, Rheumatic Diseases
- Being tested
- Current treatment (no intervention assigned)
- Keywords
- Biologic DMARD, Conventional DMARD, Coronavirus Anxiety Scale, Rheumatology, Pandemic
- Medical subject headings
- COVID-19, Anxiety Disorders, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current treatment (no intervention assigned)Other
Participants are grouped based on their current prescribed DMARD regimen; no study intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| Biologic DMARD group (bDMARD) | Adult rheumatology patients receiving biologic disease-modifying antirheumatic drugs Receives: Other: Current treatment (no intervention assigned) | |
| Conventional DMARD group (cDMARD) | Adult rheumatology patients receiving conventional disease-modifying antirheumatic drugs Receives: Other: Current treatment (no intervention assigned) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronavirus Anxiety Scale Score
Anxiety level measured using the validated Coronavirus Anxiety Scale (CAS). The total score ranges from 0 to 20, with higher scores indicating greater coronavirus-related anxiety.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Oct 2020
- Primary completion15 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Taner Dandinoğlu, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436494
- Sponsor's protocol ID
- 2026-Rheumatology-2
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coronavirus-Related Anxiety Levels in Patients Using Biologic and Conventional Disease-Modifying Antirheumatic Drugs
- ClinicalTrials.gov ID
- NCT07436494
- Acronym / sponsor ID
- 2026-Rheumatology-2
- Conditions
- COVID-19, Anxiety, Rheumatic Diseases
- Keywords
- Biologic DMARD, Conventional DMARD, Coronavirus Anxiety Scale, Rheumatology, Pandemic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 27 Feb 2026 (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 COVID-19 pandemic has caused significant psychological distress among patients with chronic diseases. Individuals receiving immunosuppressive therapies may experience increased anxiety due to perceived vulnerability to infection. This observational study aims to compare coronavirus-related anxiety levels in patients using biologic disease-modifying antirheumatic drugs (bDMARDs) and those using conventional disease-modifying antirheumatic drugs (cDMARDs).
Adult patients followed at the rheumatology outpatient clinic were contacted by telephone. After verbal consent was obtained, participants completed a patient information form and the Coronavirus Anxiety Scale. Anxiety levels and pandemic-related experiences were compared between treatment groups.
Detailed description
This observational cohort study was conducted at the Rheumatology outpatient clinic of Uludag University Faculty of Medicine. The study included adult patients diagnosed with rheumatic diseases who were receiving either biologic DMARDs (bDMARDs) or conventional DMARDs (cDMARDs).
During the COVID-19 pandemic period, patients were contacted by telephone and informed about the study. Verbal consent was obtained prior to data collection. Demographic and clinical characteristics were recorded using a structured patient information form.
Coronavirus-related anxiety was assessed using the validated Coronavirus Anxiety Scale. The primary objective was to compare anxiety scores between patients receiving biologic and conventional DMARD therapy. Secondary analyses explored patients' perceptions of infection risk and their experiences during the pandemic period.
No intervention, treatment modification, or additional clinical procedure was performed. The study design is observational, and all data were collected at a single time point.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologic DMARD group (bDMARD) | – | Other: Current treatment (no intervention assigned)Adult rheumatology patients receiving biologic disease-modifying antirheumatic drugs |
| Conventional DMARD group (cDMARD) | – | Other: Current treatment (no intervention assigned)Adult rheumatology patients receiving conventional disease-modifying antirheumatic drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with established rheumatic diseases under treatment with biologic or conventional DMARD therapy who were actively followed at a tertiary care rheumatology outpatient clinic during the COVID-19 pandemic.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Diagnosis of rheumatic disease
- Currently receiving biologic or conventional disease-modifying antirheumatic drugs (DMARDs)
- Followed at the rheumatology outpatient clinic during the COVID-19 pandemic period
- Provided verbal informed consent
Key exclusion criteria (4 listed)
- Age <18 years
- Inability to complete telephone interview
- Cognitive impairment preventing reliable questionnaire response
- Refusal to participate
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 |
|---|---|---|
| Current treatment (no intervention assigned)Participants are grouped based on their current prescribed DMARD regimen; no study intervention is administered. | Other | Biologic DMARD group (bDMARD), Conventional DMARD group (cDMARD) |
Primary outcome
Coronavirus Anxiety Scale Score
Time frame: Baseline
Anxiety level measured using the validated Coronavirus Anxiety Scale (CAS). The total score ranges from 0 to 20, with higher scores indicating greater coronavirus-related anxiety.
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 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 and Anxiety, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 27 Feb 2026. 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 Turkey (Türkiye). 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?
Coronavirus Anxiety Scale Score (time frame: Baseline). 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 27 Feb 2026.