Sars-CoV2Phase 3PREAVISNCT04522466
Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
A Phase 3 study testing Hydroxychloroquine (HCQ) in people with Sars-CoV2, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites in France.
Trial summary
To date, no treatment has demonstrated clinical efficacy on COVID 19. However, several therapeutic strategies are being considered and are being evaluated in numerous clinical trials. Among these strategies, the use of hydroxychloroquine (HCQ) seems promising. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sars-CoV2
- What is being tested?
- Hydroxychloroquine (HCQ)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 4 sitesFrance
- Study dates
- 3 Apr 2020to 28 May 2020
- Phase
- Phase 3
- 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
Who may be able to join
- Adult patients 18 years of age and older
- Patients hospitalized in the intensive care unit infected with CoV-2-SARS for whom a diagnosis of respiratory CoV-2-SARS infection has been made by nasopharyngeal swab or deep respiratory sampling.
- Patient receiving HCQ treatment as part of care or as part of a clinical trial.
- Patient affiliated or entitled to a social security scheme
Who cannot join
- Hypersensitivity to the active substances or to any of the following excipients: lactose monohydrate, povidone, corn starch, magnesium stearate.
- Retinopathies
- Combination with citalopram, escitalopram, hydroxyzine, domperidone and piperazine due to increased risk of ventricular rhythm disturbances, including torsades de pointes.
- Patient with known QT prolongation
- Known deficit in G6PD
- Pregnant woman
Trial locations and contacts
4 sites in 1 country.
France4 sites
Groupement Hospitalier des Portes de Province
Montélimar
Centre Hospitalier de Roanne
Roanne
CHU Saint-Etienne
Saint-Etienne
Clinique Mutualiste
Saint-Etienne
About this study
To date, no treatment has demonstrated clinical efficacy on COVID 19. However, several therapeutic strategies are being considered and are being evaluated in numerous clinical trials. Among these strategies, the use of hydroxychloroquine (HCQ) seems promising. There is very little information on how to precisely administer hydroxychloroquine to patients infected with SARS-CoV-2 in intensive care, which may be responsible for side effects, some of which are potentially serious. In addition, this treatment has a long half-life which increases the risk of accumulation and therefore toxicity. In view of the lack of knowledge on the pharmacokinetic / pharmacodynamic properties of hydroxychloroquine in intensive care patients infected with SARS-CoV-2, we propose to perform a prospective multicenter cohort study in order to collect the biological data necessary for this evaluation.
- Conditions
- Sars-CoV2
- Being tested
- Hydroxychloroquine (HCQ)
- Keywords
- SARS-CoV-2, Hydroxychloroquine, COVID-19, Intensive care unit, Pharmacokinetics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine (HCQ)Drug
Hydroxychloroquine (HCQ) will be administered as usual practice: dosage is adjusted to maintain a concentration between 1 and 2 mg/L.
Measure pharmacokinetics and pharmacodynamics of Hydroxychloroquine (HCQ).
| Study group | Role | What they receive |
|---|---|---|
| Patients infected by SARS-CoV-2 treated by Hydroxychloroquine | Experimental | Blood sample on patients infected by SARS-CoV-2 treated by Hydroxychloroquine Receives: Drug: Hydroxychloroquine (HCQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of hydroxychloroquine (HCQ)
measured blood concentration by blood sample results.
Measured: Up to day 21
Secondary outcomes (3)
Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval)
measured by blood sample and electrocardiogram results.
Measured: Up to day 21
Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ)
measured by blood sample
Measured: Day 1, Day 3, Day 5, Day 7, Day 14, Day 21
Pharmacokinetic model
Pharmacokinetic (area under the curve) analysis will be performed using a population approach with a non-linear mixed effects model.
Measured: Up to day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start3 Apr 2020
- Primary completion28 May 2020
- Study completion28 May 2020
Why it stopped: Stop of the study by competent authority (ANSM)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang
- Responsible party
- Sponsor
- Investigators
- Sophie PERINEL, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522466
- Sponsor's protocol ID
- 20CH065
- Other IDs
- 2020-001281-11
- Acronym
- PREAVIS
- Status last verified
- Sep 2020
- First submitted
- 19 Aug 2020
- Last updated
- 7 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 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics and Pharmacodynamics of Hydroxychloroquine in COVID-19 Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT04522466
- Acronym / sponsor ID
- PREAVIS / 20CH065
- Conditions
- Sars-CoV2
- Keywords
- SARS-CoV-2, Hydroxychloroquine, COVID-19, Intensive care unit, Pharmacokinetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stop of the study by competent authority (ANSM)
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- CHU Saint-Etienne - Laboratoire de Pharmacologie - Toxicologie - Gaz du sang
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 21 Aug 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.
To date, no treatment has demonstrated clinical efficacy on COVID 19. However, several therapeutic strategies are being considered and are being evaluated in numerous clinical trials. Among these strategies, the use of hydroxychloroquine (HCQ) seems promising. There is very little information on how to precisely administer hydroxychloroquine to patients infected with SARS-CoV-2 in intensive care, which may be responsible for side effects, some of which are potentially serious. In addition, this treatment has a long half-life which increases the risk of accumulation and therefore toxicity. In view of the lack of knowledge on the pharmacokinetic / pharmacodynamic properties of hydroxychloroquine in intensive care patients infected with SARS-CoV-2, we propose to perform a prospective multicenter cohort study in order to collect the biological data necessary for this evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients infected by SARS-CoV-2 treated by Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine (HCQ)Blood sample on patients infected by SARS-CoV-2 treated by Hydroxychloroquine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients 18 years of age and older
- Patients hospitalized in the intensive care unit infected with CoV-2-SARS for whom a diagnosis of respiratory CoV-2-SARS infection has been made by nasopharyngeal swab or deep respiratory sampling.
- Patient receiving HCQ treatment as part of care or as part of a clinical trial.
- Patient affiliated or entitled to a social security scheme
Key exclusion criteria (6 listed)
- Hypersensitivity to the active substances or to any of the following excipients: lactose monohydrate, povidone, corn starch, magnesium stearate.
- Retinopathies
- Combination with citalopram, escitalopram, hydroxyzine, domperidone and piperazine due to increased risk of ventricular rhythm disturbances, including torsades de pointes.
- Patient with known QT prolongation
- Known deficit in G6PD
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 |
|---|---|---|
| Hydroxychloroquine (HCQ)Hydroxychloroquine (HCQ) will be administered as usual practice: dosage is adjusted to maintain a concentration between 1 and 2 mg/L. Measure pharmacokinetics and pharmacodynamics of Hydroxychloroquine (HCQ). | Drug | Patients infected by SARS-CoV-2 treated by Hydroxychloroquine |
Primary outcome
Pharmacokinetics of hydroxychloroquine (HCQ)
Time frame: Up to day 21
measured blood concentration by blood sample results.
3 secondary outcomes
Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval)
Time frame: Up to day 21
Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ)
Time frame: Day 1, Day 3, Day 5, Day 7, Day 14, Day 21
Pharmacokinetic model
Time frame: Up to day 21
Results and safety
The study was stopped early (reason given: Stop of the study by competent authority (ANSM)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
Sophie PERINEL, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine (HCQ) in people with Sars-CoV2, run by Centre Hospitalier Universitaire de Saint Etienne at 4 sites 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 7 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 4 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Stop of the study by competent authority (ANSM)). Results are not available in the source record.
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?
Pharmacokinetics of hydroxychloroquine (HCQ) (time frame: Up to day 21). 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 7 Sep 2020.