NCT04314817

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

March 17, 2020

Last Update Submit

April 19, 2023

Conditions

CoronavirusIatrogenic DiseaseAcute Kidney InjuryARDS, Human

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Heart failure

    Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

  • EKG disturbance

    Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

  • Hepatic failure

    Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

  • Anemia

    Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

  • Leucopenia

    Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020

  • +6 more secondary outcomes

Study Arms (1)

Patients treated for Covid-19

Drug: Any drug used to treat Covid-19

Interventions

Any drug used to treat Covid-19DRUG

lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date.

Patients treated for Covid-19

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • all patients treated for Covid-19

You may not qualify if:

  • Chronology not compatible between the drug and the toxicity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Assistance Publique Hopitaux de Paris

Paris, France

Location

Related Publications (1)

  • Jung SY, Kim MS, Li H, Lee KH, Koyanagi A, Solmi M, Kronbichler A, Dragioti E, Tizaoui K, Cargnin S, Terrazzino S, Hong SH, Abou Ghayda R, Kim NK, Chung SK, Jacob L, Salem JE, Yon DK, Lee SW, Kostev K, Kim AY, Jung JW, Choi JY, Shin JS, Park SJ, Choi SW, Ban K, Moon SH, Go YY, Shin JI, Smith L. Cardiovascular events and safety outcomes associated with remdesivir using a World Health Organization international pharmacovigilance database. Clin Transl Sci. 2022 Feb;15(2):501-513. doi: 10.1111/cts.13168. Epub 2021 Oct 31.

    PMID: 34719115DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsIatrogenic DiseaseAcute Kidney InjuryRespiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Joe-Elie Salem, MD, PhD

    Clinical Investigations Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 19, 2020

Study Start

March 17, 2020

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

April 21, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

No individual data is available per se. They need to be retrieved from the World Health Organization.

Locations

FR(1)