Rheumatoid ArthritisNCT04434118
Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients
An observational study of Rheumatoid Arthritis and COVID, run by Sadat City University at 1 site in Egypt.
Trial summary
Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rheumatoid Arthritis, COVID
- What is being tested?
- Traditional antirheumatic drugs
- How many people
- 0 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2020to 30 Dec 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients fulfilling 2010 ACR-EULAR classification criteria for RA
Who may be able to join
- Data of all definite cases of RA were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form.
Who cannot join
- The exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients.
- Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke)
- Patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study
Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.
- Conditions
- Rheumatoid Arthritis, COVID
- Being tested
- Traditional antirheumatic drugs
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional antirheumatic drugsDrug
Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis with COVID-19 | Not described Receives: Drug: Traditional antirheumatic drugs | |
| Rheumatoid Arthritis without COVID-19 | Not described Receives: Drug: Traditional antirheumatic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of COVID-19 infection among RA patients
Realtion between hydroxychloroquine use and COVID-19 infection
Measured: 12 week
Secondary outcomes (1)
The incidence of hospitalization for Covid-19 patients.
Number of cases and number of hospitalization days
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Mar 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021 (estimated)
Why it stopped: Institutional Issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy Abdallah, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434118
- Sponsor's protocol ID
- IRB: RC-5-2020
- Status last verified
- May 2022
- First submitted
- 13 Jun 2020
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-rheumatic Drug Use and Risk of COVID-19 Infection in Rheumatoid Arthritis Patients: A Retrospective, Case-control Study
- ClinicalTrials.gov ID
- NCT04434118
- Acronym / sponsor ID
- IRB: RC-5-2020
- Conditions
- Rheumatoid Arthritis, COVID
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Institutional Issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 16 Jun 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.
Rheumatoid arthritis (RA) patients have an underlying immune deficiency and typically treated with immunosuppressive drugs, which may increase the risk of COVID-19 infection. Hydroxychloroquine (HCQ) has been found to possess antiviral activity against COVID-19. Thus, the aim of this study to investigate the ability of HCQ to reduce the risk of COVID-19 among RA patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis with COVID-19 | – | Drug: Traditional antirheumatic drugs |
| Rheumatoid Arthritis without COVID-19 | – | Drug: Traditional antirheumatic drugs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients fulfilling 2010 ACR-EULAR classification criteria for RA
Key inclusion criteria (1 listed)
- Data of all definite cases of RA were collected and reviewed from complete medical records of patients by a team that included 2 trained physicians using a pretested data collection form.
Key exclusion criteria (3 listed)
- The exclusion criteria were included incomplete medical records or those with difficulty to communicate with the patients.
- Patients with acute lethal organ injury (e.g., acute myocardial infarction, acute coronary syndrome, acute pulmonary embolism, or acute stroke)
- Patients with decompensated or end stage chronic organ dysfunction (e.g., decompensated cirrhosis, decompensated chronic renal insufficiency, or severe congestive heart failure), diabetes mellitus, data of pregnant females, acquired immune deficiency syndrome (aids), and leukemia or other malignancies.
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 |
|---|---|---|
| Traditional antirheumatic drugsHydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine | Drug | Rheumatoid Arthritis with COVID-19, Rheumatoid Arthritis without COVID-19 |
Primary outcome
The risk of COVID-19 infection among RA patients
Time frame: 12 week
Realtion between hydroxychloroquine use and COVID-19 infection
1 secondary outcome
The incidence of hospitalization for Covid-19 patients.
Time frame: 12 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Yes
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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 Rheumatoid Arthritis and COVID, run by Sadat City University at 1 site in Egypt.
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 1 inclusion and 3 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: withdrawn, as of the sponsor's last update on 9 May 2022. 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 Egypt. 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 was withdrawn before enrolling participants, so there are no results.
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?
The risk of COVID-19 infection among RA patients (time frame: 12 week). 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 9 May 2022.