Hydroxy Chloroquine and Covid in RA Patients (Covid-19)

September 7, 2020 updated by: Mohammed Hassan Abu-Zaid, Tanta University

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

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • Adult patients with rheumatoid arthritis superinfected with Covid-19

Exclusion Criteria:

  • Insufficient data are available in the medical record.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Experimental
Patient with rheumatoid arthritis using hydroxychloroquine as a part of their treatment regimen.
Active Comparator
Patient with rheumatoid arthritis not using hydroxychloroquine as a part of their treatment regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients in need for hospitalization
Time Frame: through study completion an average 12 weeks
Estimate number of patients in need for hospitalization
through study completion an average 12 weeks
Length of hospitalization and ICU admission
Time Frame: 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
through study completion an average 12 weeks
The need for mechanical ventilation
Time Frame: through study completion an average 12 weeks
Calculate the number of patients who received mechanical ventilation
through study completion an average 12 weeks
Severity of COVID-19 disease
Time Frame: through study completion an average 12 weeks
WHO clinical management Covid19 interim guidance disease severity Algorithm
through study completion an average 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Chair: Asem Elfert, Prof, Tanta University Faculty of medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 15, 2020

Study Record Updates

Last Update Posted (Actual)

September 9, 2020

Last Update Submitted That Met QC Criteria

September 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe