Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

Acute Kidney Injury Clinical Trial

— CovidTox  

Official title:

Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314817
• Other study ID #: CIC1421-20-04
• Status: Completed
• Start date: March 17, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients treated for Covid-19

Exclusion Criteria:

• Chronology not compatible between the drug and the toxicity

Related Conditions & MeSH terms

• Acute Kidney Injury
• ARDS, Human
• Coronavirus
• Coronavirus Infections
• COVID-19
• Iatrogenic Disease
• Respiratory Distress Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	AP-HP Assistance Publique Hopitaux de Paris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere	CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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