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Completed

NCT Number: NCT04314817

Adverse Events Related to Treatments Used Against Coronavirus Disease 2019

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).

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Key information

Conditions

Coronavirus ARDS, Human Acute Kidney Injury Coronaviridae Infections Coronavirus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Iatrogenic Disease Infections Kidney Diseases Lung Diseases Male Urogenital Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Urologic Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP Assistance Publique Hopitaux de Paris

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients treated for Covid-19

Exclusion criteria

  • Chronology not compatible between the drug and the toxicity

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere

Other

Collaborators

  • CMC Ambroise Paré

Registry information

Acronym: CovidTox

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2020
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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