Hydroxy Chloroquine and Covid in RA Patients

COVID Clinical Trial

— Covid-19  

Official title:

Clinical Course of COVID-19 in Patients With Rheumatoid Arthritis Treated With or Without Hydroxychloroquine: a Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04471649
• Other study ID #: 002
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: November 2020

Study information

• Verified date: September 2020
• Source: Tanta University
• Contact: Mohammed Hassan Abu-Zaid, PhD
• Phone: +201006773622
• Email: Drmhassan113[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with rheumatoid arthritis superinfected with Covid-19

Exclusion Criteria:

• Insufficient data are available in the medical record.

Related Conditions & MeSH terms

• COVID

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

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