Adverse Events Related to Treatments Used Against Coronavirus Disease 2019 (CovidTox)

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).

Study Overview

• Status: Completed
• Conditions: Iatrogenic Disease; Acute Kidney Injury; Coronavirus; ARDS, Human
• Intervention / Treatment: Drug: Any drug used to treat Covid-19

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

• Study Contact: Name: Lee S Nguyen, MD, PhDc; Phone Number: 0033158414143; Email: nguyen.lee@icloud.com

Study Locations

• France
  • Paris, France
    • AP-HP Assistance Publique Hopitaux de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

Inclusion Criteria:

• all patients treated for Covid-19

Exclusion Criteria:

• Chronology not compatible between the drug and the toxicity

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients treated for Covid-19	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal failure	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart failure	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
EKG disturbance	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Hepatic failure	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Anemia	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Leucopenia	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Vascular disease	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Toxidermia	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Osteoarticular adverse event	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Death	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Acute respiratory distress syndrome	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Pulmonary embolism or pulmonary hypertension	defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms	Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Pitie-Salpetriere
• Collaborators: CMC Ambroise Paré
• Investigators: Study Director: Joe-Elie Salem, MD, PhD, Clinical Investigations Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2020
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 19, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; COVID-19; Coronavirus Infections; Acute Kidney Injury; Respiratory Distress Syndrome; Iatrogenic Disease
• Other Study ID Numbers: CIC1421-20-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual data is available per se. They need to be retrieved from the World Health Organization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No