NCT04471649

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

4 months

First QC Date

July 7, 2020

Last Update Submit

September 7, 2020

Conditions

Keywords

Covid-19Hydroxy chloroquineRheumatoid

Outcome Measures

Primary Outcomes (4)

  • Number of patients in need for hospitalization

    Estimate number of patients in need for hospitalization

    through study completion an average 12 weeks

  • 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

  • The need for mechanical ventilation

    Calculate the number of patients who received mechanical ventilation

    through study completion an average 12 weeks

  • Severity of COVID-19 disease

    WHO clinical management Covid19 interim guidance disease severity Algorithm

    through study completion an average 12 weeks

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Adult patients with rheumatoid arthritis superinfected with Covid-19

You may not qualify if:

  • Insufficient data are available in the medical record.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University Hospital

Tanta, 31527, Egypt

RECRUITING

Related 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.

    PMID: 32173110BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Asem Elfert, Prof

    tanta university faculty of medicine

    STUDY CHAIR

Central Study Contacts

Mohammed Hassan Abu-Zaid, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 15, 2020

Study Start

June 15, 2020

Primary Completion

October 1, 2020

Study Completion

November 1, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations