CovidTox: Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Arms and Interventions
Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- all patients treated for Covid-19
Exclusion Criteria:
- Chronology not compatible between the drug and the toxicity
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | AP-HP Assistance Publique Hopitaux de Paris | Paris | France |
Sponsors and Collaborators
- Groupe Hospitalier Pitie-Salpetriere
- CMC Ambroise Paré
Investigators
- Study Director: Joe-Elie Salem, MD, PhD, Clinical Investigations Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIC1421-20-04