Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
Status:
Recruiting
Sponsors
Groupe Hospitalier Pitie-Salpetriere
Collaborators
CMC Ambroise Paré
Abstract:
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:Coronavirus
Iatrogenic Disease
Acute Kidney Injury
ARDS, Human
Intervention/treatment:
Drug: Patients treated for Covid-19
Phase:-
Study design:
Study Type:Observational
Observational Model:Case-Only
Time Perspective:Cross-Sectional
Arm group:
ArmIntervention/treatment
Patients treated for Covid-19
Drug: Patients treated for Covid-19
lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date.
Eligibility Criteria:
Sexes Eligible for Study:All
Sampling method:Non-Probability Sample
Accepts Healthy Volunteers:Yes
Criteria:

Inclusion Criteria:

- all patients treated for Covid-19

Exclusion Criteria:

- Chronology not compatible between the drug and the toxicity

Outcome:
Primary Outcome Measures
1. 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
1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
Relations:
Diseases
(2)
Conditions
(1)
Drugs
(6)
Chemicals
(1)
Genes
(1)
Organisms
(1)
Affiliates
(3)
Discussion board
Collaboration tool especially designed for Life Science professionals.Drag-and-drop any entity to your messages.