Hydroxy Chloroquine and Covid in RA Patients

• Conditions: COVID

• Registration Number: NCT04471649
• Lead Sponsor: Tanta University

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

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-07-07
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09
• Primary Completion: 2020-10
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Adult patients with rheumatoid arthritis superinfected with Covid-19

Exclusion Criteria

• Insufficient data are available in the medical record.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severity of COVID-19 disease	through study completion an average 12 weeks	WHO clinical management Covid19 interim guidance disease severity Algorithm
Length of hospitalization and ICU admission	through study completion an average 12 weeks	Calculate the number of days that the patients stayed at the hospital and how many patients admitted to ICU
The need for mechanical ventilation	through study completion an average 12 weeks	Calculate the number of patients who received mechanical ventilation
Number of patients in need for hospitalization	through study completion an average 12 weeks	Estimate number of patients in need for hospitalization

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Egypt