Clinical trial NCT04314817: Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
Official title: Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus
Iatrogenic Disease
Acute Kidney Injury
ARDS, Human
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
Collaborators: name: CMC Ambroise Paré
First posted: 2020-03-19
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a drug that could be reported in the WHO's pharmacovigilance database and with a plausible indication against Covid-19

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* all patients treated for Covid-19

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity

Primary outcomes:
measure: Renal failure
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Secondary outcomes:
measure: Heart failure
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: EKG disturbance
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Hepatic failure
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Anemia
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Leucopenia
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Vascular disease
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Toxidermia
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Osteoarticular adverse event
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Death
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Acute respiratory distress syndrome
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
measure: Pulmonary embolism or pulmonary hypertension
timeFrame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Assistance Publique Hopitaux de Paris
Study officials:
affiliation: Clinical Investigations Center
name: Joe-Elie Salem, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.