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Antimalarial and Covid 19 in Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04389320
Recruitment Status : Completed
First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Manal Hassanien, Assiut University

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).


Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Hydroxychloroquine

Detailed Description:

The antimalarial agent hydroxychloroquine(HCQ) have been used widely used for the treatment of rheumatoid arthritis and systemic lupus erythematosus.(1) . 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).

It is difficult to carefully evaluate the onslaught of information that has emerged regarding potential COVID-19 therapies within a few months' time in early 2020. A brief but detailed approach regarding how to evaluate resulting evidence of a study has been presented by F. Perry Wilson, MD, MSCE. By using the example of a case series of patients given hydroxychloroquine plus azithromycin, he provides clinicians with a quick review of critical analyses.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Antimalarial and Covid 19 in Rheumatoid Arthritis
Actual Study Start Date : March 15, 2020
Actual Primary Completion Date : May 1, 2020
Actual Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Rheumatoid patients receiving hydroxychloroquine
immunoglobulin analyses of covid 19 virus in patients already on hydroxychloroquine and relation to clinical presentation and genetics
Drug: Hydroxychloroquine
assess its role in the coarse of covid 19 virus infection




Primary Outcome Measures :
  1. immunoglobulin mesurement [ Time Frame: 1 month ]
    serum level



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
rheumatoid arthritis patients
Criteria

Inclusion Criteria:

  • rheumatoid arthritis recieving hydroxychloroquine chest infection

Exclusion Criteria:

  • patients not used hydroxychloroquine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04389320


Locations
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Egypt
Manal Hassanien
Assiut, Yes, Egypt, 7111
Sponsors and Collaborators
Assiut University
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Responsible Party: Manal Hassanien, Assistant professor, Assiut University
ClinicalTrials.gov Identifier: NCT04389320    
Other Study ID Numbers: covid 19 in RA
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: May 15, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents