CoronavirusPPT-COVIDNCT04418193
Patient Preference Trial for COVID-19 (PPT-COVID)
An observational study of Coronavirus, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
Trial summary
To date no treatment has proven its effectiveness in the caring of patients infected with type 2 Coronavirus. The Centre Hospitalier Princesse Grace (CHPG) has decided to only propose randomized double-blind placebo-controlled clinical trials to patients at the early and symptomatic stages of the disease. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronavirus
- How many people
- 0 participants
- Where
- 1 siteMonaco
- Study dates
- 6 Apr 2020to 4 Feb 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with COVID-19 infection diagnosed by positive RT-PCR SARS-CoV-2 or, if not performed, by thorax CT-scan suggesting viral pneumonia of peripheral predominance in a clinically significant context that can't or don't want to participate to a randomized clinical trial
Who may be able to join
- Adult patients (18+)
- Infection with COVID-19 diagnosed by positive RT-PCR SARS-CoV-2 or, if not performed, by thorax CT-scan suggesting viral pneumonia of peripheral predominance in a clinically significant context.
- Diagnosed within the previous 48 hours.
- Having at least one of the following two risk factors for complications:
- age ≥75 years old
- Peripheral oxygen saturation (SpO2) ≤ 94% while breathing ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg.
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- Patients affiliated with or benefitting from a social security scheme
- Written and signed consent of the patient or a relative or, if not possible, emergency inclusion procedure
- Electrocardiogram showing absence of QT prolongation greater than 440 ms in men and 460 ms in women.
- Patient that can't or don't want to participate to a randomized clinical trial
Who cannot join
- Age below 18-year of age
- Negative RT-PCR SARS-CoV-2
- Peripheral capillary oxygen saturation less than or equal to 94% (SpO2≤94%) despite oxygen therapy greater than or equal to 3 L/min (≥ 3 L/min)
- Organ failure requiring admission to a resuscitation or high dependency unit
- Comorbidity that is life-threatening in the short-term (life expectancy <3 months)
- Any reason that makes follow-up at day 28 impossible
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- Current treatment with hydroxychloroquine or hydroxychloroquine plus azithromycin
- Absolute contraindication to treatment with hydroxychloroquine (known hypersensitivity, concomitant treatment with risk of torsades de pointe) or azithromycin (known hypersensitivity to azithromycin, erythromycin, other macrolide, ketolide, in association with rye ergot alkaloids, cisapride, colchicine or severe hepatic failure)
- glucose-6-phosphate dehydrogenase (G6PD) known deficit
- Porphyria
- Hypokaliemia < 3.5 mmol/L
- Electrocardiogram showing corrected QT prolongation greater than 440 ms in men and 460 ms in women
- Child C liver cirrhosis
- Chronic kidney failure with estimated glomerular filtration rate (GFR) ≤ 30 ml/min
- Pregnant, lactating or parturient women
- Patient included in a randomized clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Management in Patients With COVID-19 Infection at Risk of Secondary Aggravation: Patient Preference Trial Comparing Routine Care, Treatment With Hydroxychloroquine or Treatment With Hydroxychloroquine Plus Azithromycin
To date no treatment has proven its effectiveness in the caring of patients infected with type 2 Coronavirus. The Centre Hospitalier Princesse Grace (CHPG) has decided to only propose randomized double-blind placebo-controlled clinical trials to patients at the early and symptomatic stages of the disease. Data from the literature show in vitro results on the potential clinical benefit of some treatments such as chloroquine or hydroxychloroquine (HXCQ). Observational data suggest a potential benefit of this treatment alone or in combination with azithromycin (HXCQ + AZ). These data were advertised or led to a request from ambulatory medicine and patients to have access to these treatments despite their poor level of evidence. This leads to a decrease in the number of patients recruitable for clinical trials because they refuse the concept of control arms or they wish active treatment (CQ, HXCQ or HXCQ + AZ) from the start.
In this context, we propose to conduct in parallel with randomized trials, a so-called "patient preference" protocol which, after patients information, gives them the choice, either to participate in the trial or to choose between treatment with HXCQ, treatment with HXCQ + AZ or standard of care without medication. The patients follow-up and the main endpoint will be the same under the patient preference protocol as for the randomized trial.
Read more
The advantage of this approach is to offer a common follow-up to all patients, to take into account patients who refuse to participate in the clinical trial, to obtain external validity data, to reduce selection bias and to increase the heterogeneity of patients exposed to treatment options.
The expected objective is to see if the patient preference protocol leads to observe the same effects as in the randomized trial.
Read the detailed description
Conduct of the research
- Pre-selection / Recruitment It is proposed to participate in the study to patients who cannot or do not wish to participate in a randomized therapeutic trial.
- Inclusion procedure During the inclusion visit, if the patient meets the study selection criteria, the investigator delivers oral and written information and responds to any patient questions.
- Follow-up of people suitable for research
- Inclusion visit The treatment chosen by the patient is administered. Socio-demographic, history, clinical and biological data are collected.
- Visit on day 3 ± 1 Hydroxychloroquinemia is dosed.
- Visit on day 5 ± 1 A nasopharyngeal swab sample is collected during the routine visit. This sampling is only performed for patients for whom the diagnosis of COVID-19 has been made by RT-PCR.
- Visit on day 10 ± 1 A nasopharyngeal swab sample is collected during the routine visit. This sampling is only performed for patients for whom the diagnosis of COVID-19 has been made by RT-PCR. Hydroxychloroquinemia is dosed.
- Visit on day 14 A visit or a telephone call is made to gather the occurrence of clinical events of interest on day 14. The treatments received during the last 14 days are collected.
- Visit on day 28 A visit or a telephone call is made to gather the occurrence of clinical events of interest on day 28.
The treatments received during the last 14 days are collected.
- Conditions
- Coronavirus
- Medical subject headings
- Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.
Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.
Measured: day 14
Secondary outcomes (12)
Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.
Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.
Measured: day 28
Clinical evolution on the World Health Organisation (WHO) Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 between day 0 and day 14
Clinical evolution on the World Health Organisation (WHO) Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 between day 0 and day 14. Score is between 0 and 8, 8 being the worst.
Measured: day 14
Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28.
Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28. Score is between 0 and 8, 8 being the worst.
Measured: day 28
Number of all-cause mortality at day 14
Number of all-cause mortality at day 14
Measured: day 14
Number of all-cause mortality at day 28
Number of all-cause mortality at day 28
Measured: day 28
Rate of positive severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) Reverse Transcriptase (RT) - Polymerase Chain Reaction (PCR) on nasopharyngeal samples at day 5
Rate of positive severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) Reverse Transcriptase (RT) - Polymerase Chain Reaction (PCR) on nasopharyngeal samples at day 5
Measured: day 5
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10
Measured: day 10
The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.
The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.
Measured: day 28
Number of all-cause mortality at day 28 in patients aged 75 and older
Number of all-cause mortality at day 28 in patients aged 75 and older
Measured: day 28
Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older
Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older. Score is between 0 and 8, 8 being the worst.
Measured: day 28
Rate of severe adverse events at day 28
Rate of severe adverse events at day 28
Measured: day 28
Number of all-cause mortality at day 14 in patients aged 75 and older
Number of all-cause mortality at day 14 in patients aged 75 and older
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start6 Apr 2020
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Why it stopped: treatments are no longer proposed to this type of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Princesse Grace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418193
- Sponsor's protocol ID
- 20-08
- Acronym
- PPT-COVID
- Status last verified
- Feb 2021
- First submitted
- 2 Jun 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Management in Patients With COVID-19 Infection at Risk of Secondary Aggravation: Patient Preference Trial Comparing Routine Care, Treatment With Hydroxychloroquine or Treatment With Hydroxychloroquine Plus Azithromycin
- ClinicalTrials.gov ID
- NCT04418193
- Acronym / sponsor ID
- PPT-COVID / 20-08
- Conditions
- Coronavirus
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: treatments are no longer proposed to this type of patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Princesse GraceUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 5 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.
To date no treatment has proven its effectiveness in the caring of patients infected with type 2 Coronavirus. The Centre Hospitalier Princesse Grace (CHPG) has decided to only propose randomized double-blind placebo-controlled clinical trials to patients at the early and symptomatic stages of the disease. Data from the literature show in vitro results on the potential clinical benefit of some treatments such as chloroquine or hydroxychloroquine (HXCQ). Observational data suggest a potential benefit of this treatment alone or in combination with azithromycin (HXCQ + AZ). These data were advertised or led to a request from ambulatory medicine and patients to have access to these treatments despite their poor level of evidence. This leads to a decrease in the number of patients recruitable for clinical trials because they refuse the concept of control arms or they wish active treatment (CQ, HXCQ or HXCQ + AZ) from the start.
In this context, we propose to conduct in parallel with randomized trials, a so-called "patient preference" protocol which, after patients information, gives them the choice, either to participate in the trial or to choose between treatment with HXCQ, treatment with HXCQ + AZ or standard of care without medication. The patients follow-up and the main endpoint will be the same under the patient preference protocol as for the randomized trial.
The advantage of this approach is to offer a common follow-up to all patients, to take into account patients who refuse to participate in the clinical trial, to obtain external validity data, to reduce selection bias and to increase the heterogeneity of patients exposed to treatment options.
The expected objective is to see if the patient preference protocol leads to observe the same effects as in the randomized trial.
Detailed description
Conduct of the research
- Pre-selection / Recruitment It is proposed to participate in the study to patients who cannot or do not wish to participate in a randomized therapeutic trial.
- Inclusion procedure During the inclusion visit, if the patient meets the study selection criteria, the investigator delivers oral and written information and responds to any patient questions.
- Follow-up of people suitable for research
- Inclusion visit The treatment chosen by the patient is administered. Socio-demographic, history, clinical and biological data are collected.
- Visit on day 3 ± 1 Hydroxychloroquinemia is dosed.
- Visit on day 5 ± 1 A nasopharyngeal swab sample is collected during the routine visit. This sampling is only performed for patients for whom the diagnosis of COVID-19 has been made by RT-PCR.
- Visit on day 10 ± 1 A nasopharyngeal swab sample is collected during the routine visit. This sampling is only performed for patients for whom the diagnosis of COVID-19 has been made by RT-PCR. Hydroxychloroquinemia is dosed.
- Visit on day 14 A visit or a telephone call is made to gather the occurrence of clinical events of interest on day 14. The treatments received during the last 14 days are collected.
- Visit on day 28 A visit or a telephone call is made to gather the occurrence of clinical events of interest on day 28.
The treatments received during the last 14 days are collected.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with COVID-19 infection diagnosed by positive RT-PCR SARS-CoV-2 or, if not performed, by thorax CT-scan suggesting viral pneumonia of peripheral predominance in a clinically significant context that can't or don't want to participate to a randomized clinical trial
Key inclusion criteria (10 listed)
- Adult patients (18+)
- Infection with COVID-19 diagnosed by positive RT-PCR SARS-CoV-2 or, if not performed, by thorax CT-scan suggesting viral pneumonia of peripheral predominance in a clinically significant context.
- Diagnosed within the previous 48 hours.
- Having at least one of the following two risk factors for complications:
- age ≥75 years old
Key exclusion criteria (16 listed)
- Age below 18-year of age
- Negative RT-PCR SARS-CoV-2
- Peripheral capillary oxygen saturation less than or equal to 94% (SpO2≤94%) despite oxygen therapy greater than or equal to 3 L/min (≥ 3 L/min)
- Organ failure requiring admission to a resuscitation or high dependency unit
- Comorbidity that is life-threatening in the short-term (life expectancy <3 months)
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
Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.
Time frame: day 14
Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment.
12 secondary outcomes
Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.
Time frame: day 28
Clinical evolution on the World Health Organisation (WHO) Ordinal Scale for Clinical Improvement (OSCI) for COVID-19 between day 0 and day 14
Time frame: day 14
Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28.
Time frame: day 28
Number of all-cause mortality at day 14
Time frame: day 14
Number of all-cause mortality at day 28
Time frame: day 28
Rate of positive severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) Reverse Transcriptase (RT) - Polymerase Chain Reaction (PCR) on nasopharyngeal samples at day 5
Time frame: day 5
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10
Time frame: day 10
The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.
Time frame: day 28
Number of all-cause mortality at day 28 in patients aged 75 and older
Time frame: day 28
Clinical evolution on the WHO OSCI scale for COVID-19 between day 0 and day 28 for patients aged 75 or older
Time frame: day 28
Rate of severe adverse events at day 28
Time frame: day 28
Number of all-cause mortality at day 14 in patients aged 75 and older
Time frame: day 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Centre Hospitalier Princesse Grace at 1 site in Monaco.
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 10 inclusion and 16 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: withdrawn, as of the sponsor's last update on 9 Feb 2021. 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 Monaco. 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 was withdrawn before enrolling participants, so there are no results.
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?
Number of death from any cause, or the need for intubation and mechanical ventilation during the 14 days following inclusion and start of treatment. (time frame: day 14). 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 9 Feb 2021.