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

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ClinicalTrials.gov Identifier: NCT04347798
Recruitment Status : Enrolling by invitation
First Posted : April 15, 2020
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment
Covid-19 Infection Rheumatoid Arthritis Psoriatic Arthritis Hydroxychloroquine Other: Hydroxychloroquine/Chloroquine

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: IMPACT RAPPORT: IMPact of Antimalarials on Covid Infections: a Case Control sTudy of RAPPORT
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021


Group/Cohort Intervention/treatment
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
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 + 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)



Primary Outcome Measures :
  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 [ Time Frame: 12 months ]
    Number of patients developing signs and symptoms of Covid-19 or other infections


Secondary Outcome Measures :
  1. Incidence of Covid-19 infection in the anti-malarial group compared to the non-anti-malarial group [ Time Frame: 12 months ]
    Number of patients developing Covid-19 infection

  2. Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action [ Time Frame: 12 months ]
    Incidence of Covid-19 infection in the sub-groups of patients on biologic agents with different mechanisms of action


Other Outcome Measures:
  1. Quantification of Covid-19 antibodies in anti-malarial vs non-anti-malarial groups of inflammatory arthritis patients [ Time Frame: 6 months ]
    Quantitative measurement of Covid-19 serology to understand possible differences in degree of immune response adjusted for anti-malarial and/or biologic exposure


Biospecimen Retention:   Samples Without DNA
Blood sample for Covid-19 serology, ABO blood type, HLA typing


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT04347798


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Stephanie O Keeling, MD University of Alberta
Principal Investigator: Walter P Maksymowych, MD University of Alberta
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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT04347798    
Other Study ID Numbers: Pro00100000
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by University of Alberta:
Rheumatoid arthritis
Psoriatic arthritis
Covid-19
Hydroxychloroquine
Chloroquine
Anti-malarials
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Hydroxychloroquine
Chloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides