Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT04418193
Status:
WITHDRAWN
Last Update Posted:
2021-02-09
First Post:
2020-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Preference Trial for COVID-19 (PPT-COVID)
Sponsor:
Centre Hospitalier Princesse Grace
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
treatments are no longer proposed to this type of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPT-COVID
Brief 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. 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.
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
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.
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: