Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

NCT ID: NCT04314817

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-17

Study Completion Date

2023-01-01

Brief Summary

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The outbreak of Covid-19 started several clinical trials and treatment experiments all over the world in the first months of 2020. This study investigates reports of adverse events related to used molecules, including but not limited to protease inhibitors (lopinavir/ritonavir), chloroquine, azithromycin, remdesivir and interferon beta-1a. Analyses of reports also include the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).

Detailed Description

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Conditions

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Coronavirus Iatrogenic Disease Acute Kidney Injury ARDS, Human

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients treated for Covid-19

Any drug used to treat Covid-19

Intervention Type DRUG

lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date.

Interventions

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Any drug used to treat Covid-19

lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* all patients treated for Covid-19

Exclusion Criteria

* Chronology not compatible between the drug and the toxicity
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role lead

Responsible Party

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Lee S Nguyen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joe-Elie Salem, MD, PhD

Role: STUDY_DIRECTOR

Clinical Investigations Center

Locations

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AP-HP Assistance Publique Hopitaux de Paris

Paris, , France

Site Status

Countries

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France

References

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Jung SY, Kim MS, Li H, Lee KH, Koyanagi A, Solmi M, Kronbichler A, Dragioti E, Tizaoui K, Cargnin S, Terrazzino S, Hong SH, Abou Ghayda R, Kim NK, Chung SK, Jacob L, Salem JE, Yon DK, Lee SW, Kostev K, Kim AY, Jung JW, Choi JY, Shin JS, Park SJ, Choi SW, Ban K, Moon SH, Go YY, Shin JI, Smith L. Cardiovascular events and safety outcomes associated with remdesivir using a World Health Organization international pharmacovigilance database. Clin Transl Sci. 2022 Feb;15(2):501-513. doi: 10.1111/cts.13168. Epub 2021 Oct 31.

Reference Type DERIVED
PMID: 34719115 (View on PubMed)

Other Identifiers

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CIC1421-20-04

Identifier Type: -

Identifier Source: org_study_id

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