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 Type
OBSERVATIONAL
Enrollment
1,000
lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date.
AP-HP Assistance Publique Hopitaux de Paris
Paris, France
Renal failure
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Heart failure
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
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