Hydroxy Chloroquine and Covid in RA Patients (Covid-19)
Clinical Course of COVID-19 in Patients With Rheumatoid Arthritis Treated With or Without Hydroxychloroquine: a Case-control Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Study settings & sample:
This is an observational, retrospective -case-control, single-center study. This study will include patients who meet the inclusion criteria followed in the Department of Rheumatology and Rehabilitation, Tanta University Hospital, Tanta, Egypt.
Data will be taken from the medical records of patients with rheumatoid arthritis in the outpatient clinic of the Rheumatology and Rehabilitation Department, Tanta University Hospital, Tanta, Egypt. All patients will sign the informed consent form authorizing the collection of these data.
Group classification A) Patients with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
b) Patients with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen.
Data will be collected and analyzed from patient medical records. It will include the following:
- Epidemiologic, demographic, and clinical data.
- Severity of rheumatoid arthritis.
- Rheumatoid arthritis activity state using the Clinical Disease Activity Index
- Dose and duration of hydroxychloroquine
- Need for hospitalization, length of hospital stay, and ICU admission including the need for mechanical ventilation.
- Duration from the start of symptoms until clinical cure.
- Severity of COVID-19 disease according to the World Health Organization interim guidance
- Prognosis.
Laboratory investigations and imaging:
- Complete blood count.
- Renal and liver function tests.
- Random blood sugar.
- Lactate dehydrogenase, D-dimer.
- Serum ferritin, C-reactive protein,
- Chest radiographs or CT scan
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Tanta, Egypt, 31527
- Rekruttering
- Tanta University Hospital
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Ta kontakt med:
- Mohammed Hassan Abu-Zaid, PhD
- Telefonnummer: +201006773622
- E-post: drmhassan113@yahoo.com
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Ta kontakt med:
- Samar A Tabra, PhD
- Telefonnummer: +201007501572
- E-post: dr_stabra_113@yahoo.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
To Evaluaye the clinical course of COVID-19 in a cohort of patients with rheumatoid arthritis treated with or without hydroxychloroquine:
Data will be taken from the medical records of patients with rheumatoid arthritis in the outpatient clinic of the Rheumatology and Rehabilitation department, Tanta University hospital, Tanta, Egypt.
A) Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
b) Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen.
Primary Outcome Measures:
1. Impact of hydroxychloroquine on the clinical course of Covid-19 in the hydroxychloroquine group compared to the non- hydroxychloroquine group.
Data will be collected and analyzed from patient medical records.
Beskrivelse
Inclusion Criteria:
- Adult patients with rheumatoid arthritis superinfected with Covid-19
Exclusion Criteria:
- Insufficient data are available in the medical record.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Retrospektiv
Kohorter og intervensjoner
Gruppe / Kohort |
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Experimental
Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
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Active Comparator
Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of patients in need for hospitalization
Tidsramme: through study completion an average 12 weeks
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Estimate number of patients in need for hospitalization
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through study completion an average 12 weeks
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Length of hospitalization and ICU admission
Tidsramme: through study completion an average 12 weeks
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Calculate the number of days that the patients stayed at the hospital and how many patients admitted to ICU
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through study completion an average 12 weeks
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The need for mechanical ventilation
Tidsramme: through study completion an average 12 weeks
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Calculate the number of patients who received mechanical ventilation
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through study completion an average 12 weeks
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Severity of COVID-19 disease
Tidsramme: through study completion an average 12 weeks
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WHO clinical management Covid19 interim guidance disease severity Algorithm
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through study completion an average 12 weeks
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Asem Elfert, Prof, Tanta University Faculty of Medicine
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 002 (University of CT Health Center)
Plan for individuelle deltakerdata (IPD)
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