Hydroxy Chloroquine and Covid in RA Patients

NCT ID: NCT04471649

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2020-11-30

Brief Summary

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evaluation of the clinical course of COVID-19 in a cohort of patients with rheumatoid arthritis treated with or without hydroxychloroquine.

Detailed Description

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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:

1. Epidemiologic, demographic, and clinical data.
2. Severity of rheumatoid arthritis.
3. Rheumatoid arthritis activity state using the Clinical Disease Activity Index
4. Dose and duration of hydroxychloroquine
5. Need for hospitalization, length of hospital stay, and ICU admission including the need for mechanical ventilation.
6. Duration from the start of symptoms until clinical cure.
7. Severity of COVID-19 disease according to the World Health Organization interim guidance
8. Prognosis.

Laboratory investigations and imaging:

1. Complete blood count.
2. Renal and liver function tests.
3. Random blood sugar.
4. Lactate dehydrogenase, D-dimer.
5. Serum ferritin, C-reactive protein,
6. Chest radiographs or CT scan

Conditions

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COVID

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Experimental

Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.

No interventions assigned to this group

Active Comparator

Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients with rheumatoid arthritis superinfected with Covid-19

Exclusion Criteria

* Insufficient data are available in the medical record.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Hassan Abu-Zaid

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Asem Elfert, Prof

Role: STUDY_CHAIR

tanta university faculty of medicine

Locations

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Tanta University Hospital

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mohammed Hassan Abu-Zaid, PhD

Role: CONTACT

+201006773622

Samar Tabra, PhD

Role: CONTACT

+201007501572

Facility Contacts

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Mohammed Hassan Abu-Zaid, PhD

Role: primary

+201006773622

Samar A Tabra, PhD

Role: backup

+201007501572

References

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Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.

Reference Type BACKGROUND
PMID: 32173110 (View on PubMed)

Other Identifiers

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002

Identifier Type: -

Identifier Source: org_study_id

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