Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adverse Events Related to Treatments Used Against Coronavirus Disease 2019 (CovidTox)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04314817
Recruitment Status : Recruiting
First Posted : March 19, 2020
Last Update Posted : April 14, 2021
Sponsor:
Collaborator:
CMC Ambroise Paré
Information provided by (Responsible Party):
Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere

Tracking Information
First Submitted Date March 17, 2020
First Posted Date March 19, 2020
Last Update Posted Date April 14, 2021
Actual Study Start Date March 17, 2020
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 18, 2020)
Renal failure [ Time Frame: 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
Original Primary Outcome Measures
 (submitted: March 17, 2020)
Adverse event [ Time Frame: 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
Change History
Current Secondary Outcome Measures
 (submitted: March 18, 2020)
  • Heart failure [ Time Frame: 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
  • EKG disturbance [ Time Frame: 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
  • Hepatic failure [ Time Frame: 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
  • Anemia [ Time Frame: 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
  • Leucopenia [ Time Frame: 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
  • Vascular disease [ Time Frame: 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
  • Toxidermia [ Time Frame: 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
  • Osteoarticular adverse event [ Time Frame: 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
  • Death [ Time Frame: 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
  • Acute respiratory distress syndrome [ Time Frame: 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
  • Pulmonary embolism or pulmonary hypertension [ Time Frame: 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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
Official Title Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients treated with a drug that could be reported in the WHO's pharmacovigilance database and with a plausible indication against Covid-19
Condition
  • Coronavirus
  • Iatrogenic Disease
  • Acute Kidney Injury
  • ARDS, Human
Intervention 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.
Study Groups/Cohorts Patients treated for Covid-19
Intervention: Drug: Any drug used to treat Covid-19
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 17, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 1, 2023
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all patients treated for Covid-19

Exclusion Criteria:

  • Chronology not compatible between the drug and the toxicity
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Lee S Nguyen, MD, PhDc 0033158414143 nguyen.lee@icloud.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04314817
Other Study ID Numbers CIC1421-20-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No individual data is available per se. They need to be retrieved from the World Health Organization.
Responsible Party Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere
Study Sponsor Groupe Hospitalier Pitie-Salpetriere
Collaborators CMC Ambroise Paré
Investigators
Study Director: Joe-Elie Salem, MD, PhD Clinical Investigations Center
PRS Account Groupe Hospitalier Pitie-Salpetriere
Verification Date April 2021