Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

Study Overview
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Brief Summary
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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).

Official Title
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Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

Conditions
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Coronavirus, Iatrogenic Disease, Acute Kidney Injury, ARDS, Human

Intervention / Treatment
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* Drug: Any drug used to treat Covid-19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients treated for Covid-19 Exclusion Criteria: Chronology not compatible between the drug and the toxicity
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated for Covid-19<br> | Drug: Any drug used to treat Covid-19<br>* lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |