CoronavirusCovidToxNCT04314817
Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
An observational study of Coronavirus and Iatrogenic Disease, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronavirus, Iatrogenic Disease, Acute Kidney Injury
- What is being tested?
- Any drug used to treat Covid-19
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2020to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- all patients treated for Covid-19
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Coronavirus, Iatrogenic Disease, Acute Kidney Injury, ARDS, Human
- Being tested
- Any drug used to treat Covid-19
- Medical subject headings
- Coronavirus Infections, Iatrogenic Disease, Acute Kidney Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated for Covid-19 | Not described Receives: Drug: Any drug used to treat Covid-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal failure
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Secondary outcomes (11)
Heart failure
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
EKG disturbance
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Hepatic failure
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Anemia
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Leucopenia
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Vascular disease
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Toxidermia
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Osteoarticular adverse event
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Death
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Acute respiratory distress syndrome
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Pulmonary embolism or pulmonary hypertension
defined by the Medical Dictionary for Regulatory Activities (MeDRA) terms
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start17 Mar 2020
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Collaborators
- CMC Ambroise Paré
- Responsible party
- Principal investigator, Lee S Nguyen, Groupe Hospitalier Pitie-Salpetriere
- Investigators
- Joe-Elie Salem, MD, PhD, Study director, Clinical Investigations Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314817
- Sponsor's protocol ID
- CIC1421-20-04
- Acronym
- CovidTox
- Status last verified
- Apr 2023
- First submitted
- 17 Mar 2020
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data is available per se. They need to be retrieved from the World Health Organization.
Publications
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.
PubMed 34719115
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Events Related to Treatments Used Against Coronavirus Disease 2019
- ClinicalTrials.gov ID
- NCT04314817
- Acronym / sponsor ID
- CovidTox / CIC1421-20-04
- Conditions
- Coronavirus, Iatrogenic Disease, Acute Kidney Injury, ARDS, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- CMC Ambroise Paré
- Study start
- 17 Mar 2020 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 19 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated for Covid-19 | – | Drug: Any drug used to treat Covid-19 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- all patients treated for Covid-19
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Any drug used to treat Covid-19lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date. | Drug | Patients treated for Covid-19 |
Primary outcome
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
11 secondary outcomes
Heart failure
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
EKG disturbance
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Hepatic failure
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Anemia
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Leucopenia
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Vascular disease
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Toxidermia
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Osteoarticular adverse event
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Death
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
Acute respiratory distress syndrome
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 34719115Jung 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.
- Individual participant dataSharing planned: No. No individual data is available per se. They need to be retrieved from the World Health Organization.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe-Elie Salem, MD, PhD study director
Clinical Investigations Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronavirus and Iatrogenic Disease, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal failure (time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 17/03/2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04314817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.