Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

Completed

• Conditions: Coronavirus; Iatrogenic Disease; ARDS, Human; Acute Kidney Injury
• Interventions: Drug: Any drug used to treat Covid-19

• Registration Number: NCT04314817
• Lead Sponsor: Groupe Hospitalier Pitie-Salpetriere

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-17
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• all patients treated for Covid-19

Exclusion Criteria

• Chronology not compatible between the drug and the toxicity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated for Covid-19	Any drug used to treat Covid-19	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AP-HP Assistance Publique Hopitaux de Paris; 🇫🇷 Paris, France