NCT04389320

Brief Summary

The antimalarial agent hydroxychloroquine(HCQ) have been used widely used for the treatment of rheumatoid arthritis and systemic lupus erythematosus. These compounds lead to improvement of clinical and laboratory parameters, but their slow onset of action differ them from glucocorticoids and nonsteroidal antiinflammatory agents. Among rheumatic diseases, the primary role of HCQ is in the management of articular and skin manifestations of systemic lupus erythematosus (SLE) and the treatment of mild to moderately active rheumatoid arthritis (RA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2020

Completed
Last Updated

May 15, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 11, 2020

Last Update Submit

May 13, 2020

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • immunoglobulin mesurement

    serum level

    1 month

Study Arms (1)

Rheumatoid patients receiving hydroxychloroquine

immunoglobulin analyses of covid 19 virus in patients already on hydroxychloroquine and relation to clinical presentation and genetics

Drug: Hydroxychloroquine

Interventions

HydroxychloroquineDRUG

assess its role in the coarse of covid 19 virus infection

Rheumatoid patients receiving hydroxychloroquine

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

rheumatoid arthritis patients

You may qualify if:

  • rheumatoid arthritis recieving hydroxychloroquine chest infection

You may not qualify if:

  • patients not used hydroxychloroquine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manal Hassanien

Asyut, Yes, 7111, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 15, 2020

Study Start

March 15, 2020

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

May 15, 2020

Record last verified: 2020-05

Locations

EG(1)