CovidTox: Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

Sponsor
Groupe Hospitalier Pitie-Salpetriere (Other)
Overall Status
Recruiting
CT.gov ID
NCT04314817
Collaborator
CMC Ambroise Paré (Other)
1,000
1
33.5
29.8

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
  • Drug: Any drug used to treat Covid-19

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
Actual Study Start Date :
Mar 17, 2020
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

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

  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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ParĂ©

Investigators

  • Study Director: Joe-Elie Salem, MD, PhD, Clinical Investigations Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lee S Nguyen, Principal Investigator, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier:
NCT04314817
Other Study ID Numbers:
  • CIC1421-20-04
First Posted:
Mar 19, 2020
Last Update Posted:
Apr 14, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2021