Patient Preference Trial for COVID-19 (PPT-COVID) (PPT-COVID)

February 4, 2021 updated by: Centre Hospitalier Princesse Grace

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

    1. Inclusion visit The treatment chosen by the patient is administered. Socio-demographic, history, clinical and biological data are collected.
    2. Visit on day 3 ± 1 Hydroxychloroquinemia is dosed.
    3. 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.
    4. 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.
    5. 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.
    6. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Monaco
      • Monaco, Monaco, 98000
        • Centre Hospitalier Princesse Grace

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Number of death from any cause, or the need for intubation and mechanical ventilation during the 28 days following inclusion and start of treatment.
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 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.
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
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.
day 28
Number of all-cause mortality at day 14
Time Frame: day 14
Number of all-cause mortality at day 14
day 14
Number of all-cause mortality at day 28
Time Frame: day 28
Number of all-cause mortality at day 28
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 severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) Reverse Transcriptase (RT) - Polymerase Chain Reaction (PCR) on nasopharyngeal samples at day 5
day 5
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10
Time Frame: day 10
Rate of positive SARS-CoV-2 RT-PCR on nasopharyngeal samples at day 10
day 10
The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.
Time Frame: day 28
The rate of venous thromboembolic events at day 28, documented and confirmed by an adjudication committee.
day 28
Number of all-cause mortality at day 28 in patients aged 75 and older
Time Frame: day 28
Number of all-cause mortality at day 28 in patients aged 75 and older
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
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.
day 28
Rate of severe adverse events at day 28
Time Frame: day 28
Rate of severe adverse events at day 28
day 28
Number of all-cause mortality at day 14 in patients aged 75 and older
Time Frame: day 14
Number of all-cause mortality at day 14 in patients aged 75 and older
day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Princesse Grace

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronavirus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings