Clinical trial NCT04471649: Hydroxy Chloroquine and Covid in RA Patients
Official title: Clinical Course of COVID-19 in Patients With Rheumatoid Arthritis Treated With or Without Hydroxychloroquine: a Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID
Keywords: Covid-19
Hydroxy chloroquine
Rheumatoid
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Adult patients with rheumatoid arthritis superinfected with Covid-19

Exclusion Criteria:

* Insufficient data are available in the medical record.

Primary outcomes:
measure: Number of patients in need for hospitalization
timeFrame: through study completion an average 12 weeks
measure: Length of hospitalization and ICU admission
timeFrame: through study completion an average 12 weeks
measure: The need for mechanical ventilation
timeFrame: through study completion an average 12 weeks
measure: Severity of COVID-19 disease
timeFrame: through study completion an average 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospital
Study officials:
affiliation: tanta university faculty of medicine
name: Asem Elfert, Prof
role: STUDY_CHAIR
References:
citation: 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.