IMPACT: IMPact of Antimalarials on Covid-19 Infections in RAPPORT

NCT04347798 | Completed

• 1 other identifier: Pro00100000
• Study Type: observational
• Target: 773
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the experience of Alberta patients with inflammatory arthritis who participate in the the RAPPORT-ONTRAAC registry during the COVID-19 pandemic, specifically comparing the experience of those taking anti-malarial medications compared to those who do not. This registry includes approximately 2500 northern Alberta patients with inflammatory arthritis who receive highly complex therapies which may be associated with side effects. This program of data collection and research has been evaluating the effectiveness and safety as well as associated health care costs of rheumatoid and psoriatic arthritis patients since 2004. The principle investigators are based at the University of Alberta while the co-investigators are academic rheumatologists at the University of Alberta. The registry has approximately 900 patients taking anti-malarials combined with their complex therapies and \~ 1500 not on anti-malarials in combination with their complex therapies. We aim to perform a case control study evaluating the impact of anti-malarial drugs (eg. hydroxychloroquine and chloroquine) on the development of COVID-19 compared to those patients who are not on anti-malarial drugs over the next 6-12 months. In addition to frequent e-mail surveys screening for the clinical symptoms of COVID-19 and understanding their concomitant arthritis medication use, we will compare the healthcare outcomes of both groups of arthritis patients with and without COVID-19 for the duration of the pandemic. This information will provide critical information beyond an anecdotal level on whether or not anti-malarials truly provide a protective benefit against COVID-19 or reduce the severity of infection. A blood sample from all participants (Covid-19 positive and negative) will be drawn approximately six months into the study for measurement of antibodies to Covid-19 and possible blood types and HLA alleles. Additionally, this study will be linked to another study "Persistence of SARS-Cov2 in immunocompromised patients" which will specifically evaluate COVID-19 serology and nasopharyngeal swab findings in the subset of patients who develop COVID-19.

Conditions

Covid-19 Infection; Rheumatoid Arthritis; Psoriatic Arthritis; Hydroxychloroquine

Keywords

Rheumatoid arthritis; Psoriatic arthritis; Covid-19; Hydroxychloroquine; Chloroquine; Anti-malarials

Outcome Measures

Primary Outcomes (1)

• Impact of anti-malarials on the development and severity of Covid-19 in the anti-malarial group compared to the non-anti-malarial group

  Number of patients developing signs and symptoms of Covid-19 or other infections

  12 months

Secondary Outcomes (2)

• Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group

  12 months

• Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action

  12 months

Other Outcomes (1)

• Quantification of Covid-19 antibodies in anti-malarial vs non-anti-malarial groups of inflammatory arthritis patients

  6 months

Study Arms (2)

Inflammatory arthritis patients on biologic + anti-malarial

Patients in northern Alberta receiving hydroxychloroquine or chloroquine +/- other disease modifying anti-rheumatic drug + biologic (anti-TNF inhibitor or anti-IL-6 blocker or B-cell depletor or JAK kinase inhibitor or T-cell c-stimulation inhibitor or IL-17 blocker)

Other: Hydroxychloroquine/Chloroquine

Inflammatory arthritis patients on biologic + NO anti-malarial

Patients in northern Alberta receiving a biologic (anti-TNF inhibitor or anti-IL-6 blocker or B-cell depletor or JAK kinase inhibitor or T-cell c-stimulation inhibitor or IL-17 blocker) +/- any disease modifying anti-rheumatic drug except for anti-malarials (hydroxychloroquine or chloroquine)

Interventions

Hydroxychloroquine/Chloroquine OTHER

Prospective evaluation of development of Covid-19 in inflammatory arthritis patients on biologics with anti-malarials compared to inflammatory arthritis patients on biologics without anti-malarial exposure

Inflammatory arthritis patients on biologic + anti-malarial

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

\- Adult patients with rheumatoid or psoriatic arthritis in northern Alberta who are followed in the RAPPORT registry; all patients are on a biologic agent and possibly one or more disease modifying anti-rheumatic drug (eg. hydroxychloroquine, chloroquine, methotrexate, leflunomide, gold, azathioprine, sulfasalazine)

You may qualify if:

• Current active and consented patient of the Rheumatoid Arthritis Pharmacovigilance Program of Northern Alberta with an e-mail or mailing address

You may not qualify if:

• Unable to read English; not consenting to be contacted for future studies

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2G3, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for Covid-19 serology, ABO blood type, HLA typing

MeSH Terms

Conditions

COVID-19; Arthritis, Rheumatoid; Arthritis, Psoriatic

Interventions

Hydroxychloroquine; Chloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Stephanie O Keeling, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Walter P Maksymowych, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: November 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: September 19, 2024

Record last verified: 2023-03

Locations

CA (1)