- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04471649
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
Studieoversigt
Status
Betingelser
Detaljeret 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
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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Tanta, Egypten, 31527
- Rekruttering
- Tanta University Hospital
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Kontakt:
- Mohammed Hassan Abu-Zaid, PhD
- Telefonnummer: +201006773622
- E-mail: drmhassan113@yahoo.com
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Kontakt:
- Samar A Tabra, PhD
- Telefonnummer: +201007501572
- E-mail: dr_stabra_113@yahoo.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tilbagevirkende kraft
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Asem Elfert, Prof, Tanta University Faculty of medicine
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 002 (University of CT Health Center)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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