Acute Kidney Injury, ARDS, Human, Coronavirus, Iatrogenic Disease
Conditions
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).
Interventions
DRUGAny 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.
Sponsors
CMC Ambroise Paré
Groupe Hospitalier Pitie-Salpetriere
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* all patients treated for Covid-19
Exclusion criteria
* Chronology not compatible between the drug and the toxicity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed