COVID-19NCT04452617
Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
An observational study of COVID-19, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients. Many raised concerns regarding the potential cardiac toxicity of this association. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2020to 1 Jul 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients admitted in ICU for severe COVID-19 with respiratory failure and a short term treatment with hydroxychloroquine (HCQ) and azithromycin (AZ): * HCQ administered at a daily dosage of 600mg in 3 doses for 10 days. * AZ administered at a dosage of 500mg on the first day and then 250mg/day for 4 to 6 days.
Who may be able to join
- critically ill patients admitted in ICU for severe COVID-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin.
Who cannot join
- cardiac conduction disorders
- continuous anti-arrhythmic therapy
- heart failure
- chronic renal failure
Trial locations and contacts
1 site in 1 country.
About this study
Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients.
Many raised concerns regarding the potential cardiac toxicity of this association.
The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure.
The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.
- Conditions
- COVID-19
- Keywords
- hydroxychloroquine, ADRS, azithromycine, torsade de pointe
- Medical subject headings
- COVID-19, Torsades de Pointes
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death
Measured: 30 days after admission in ICU
Secondary outcomes (1)
assessment of QTc interval prolongation during the treatment period compared to baseline ECG
QTc (corrected QT interval) > 500 ms and ΔQTc > 60 ms
Measured: daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start19 Mar 2020
- Primary completion8 Apr 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyes KNANI, Doctor, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452617
- Sponsor's protocol ID
- REA-03-2020
- Status last verified
- Aug 2020
- First submitted
- 26 Jun 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Short-term Hydroxychloroquine Plus Azithromycin Treatment in Critically Ill Patients With Severe COVID-19
- ClinicalTrials.gov ID
- NCT04452617
- Acronym / sponsor ID
- REA-03-2020
- Conditions
- COVID-19
- Keywords
- hydroxychloroquine, ADRS, azithromycine, torsade de pointe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 30 Jun 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.
Hydroxychloroquine and azithromycin have been proposed as treatment of COVID-19 patients, but few reports have assessed this combination therapy in critically ill COVID-19 patients.
Many raised concerns regarding the potential cardiac toxicity of this association.
The purpose of this monocenter retrospective observational study is to evaluate the safety of a short term treatment with hydroxychloroquine and azithromycin in critically ill patients admitted in ICU for severe COVID-19 with respiratory failure.
The main objective is to assess the incidence of severe cardiac arrhythmia e.g torsade de pointes and cardiac arrest or sudden death, during the treatment period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted in ICU for severe COVID-19 with respiratory failure and a short term treatment with hydroxychloroquine (HCQ) and azithromycin (AZ): * HCQ administered at a daily dosage of 600mg in 3 doses for 10 days. * AZ administered at a dosage of 500mg on the first day and then 250mg/day for 4 to 6 days.
Key inclusion criteria (1 listed)
- critically ill patients admitted in ICU for severe COVID-19 with respiratory failure for at least two days of treatment with hydroxychloroquine and azithromycin.
Key exclusion criteria (4 listed)
- cardiac conduction disorders
- continuous anti-arrhythmic therapy
- heart failure
- chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death
Time frame: 30 days after admission in ICU
1 secondary outcome
assessment of QTc interval prolongation during the treatment period compared to baseline ECG
Time frame: daily
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 1 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Lyes KNANI, Doctor principal investigator
Institut Mutualiste Montsouris
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 COVID-19, run by Institut Mutualiste Montsouris 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 4 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 1 Sep 2020. 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?
occurrence of severe cardiac arrhythmia: torsade de pointes and cardiac arrest or sudden death (time frame: 30 days after admission in ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2020.