Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CMC Ambroise Paré | OTHER |
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated for Covid-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Any drug used to treat Covid-19 | Drug | lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| EKG disturbance |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients treated with a drug that could be reported in the WHO's pharmacovigilance database and with a plausible indication against Covid-19
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Joe-Elie Salem, MD, PhD | Clinical Investigations Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP Assistance Publique Hopitaux de Paris | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34719115 | Derived | Jung SY, Kim MS, Li H, Lee KH, Koyanagi A, Solmi M, Kronbichler A, Dragioti E, Tizaoui K, Cargnin S, Terrazzino S, Hong SH, Abou Ghayda R, Kim NK, Chung SK, Jacob L, Salem JE, Yon DK, Lee SW, Kostev K, Kim AY, Jung JW, Choi JY, Shin JS, Park SJ, Choi SW, Ban K, Moon SH, Go YY, Shin JI, Smith L. Cardiovascular events and safety outcomes associated with remdesivir using a World Health Organization international pharmacovigilance database. Clin Transl Sci. 2022 Feb;15(2):501-513. doi: 10.1111/cts.13168. Epub 2021 Oct 31. |
Not provided
Not provided
No individual data is available per se. They need to be retrieved from the World Health Organization.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D007049 | Iatrogenic Disease |
| D058186 | Acute Kidney Injury |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D007239 |
| Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |