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

NCT04418193 | Withdrawn

• 1 other identifier: 20-08
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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

  day 14

• Clinical evolution on the WHO Ordinal Scale for Clinical Improvement for COVID-19 between day 0 and day 28.

  day 28

• Number of all-cause mortality at day 14

  day 14

• Number of all-cause mortality at day 28

  day 28

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Princesse Grace: lead

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 5, 2020
• Study Start: April 6, 2020
• Primary Completion: February 4, 2021
• Study Completion: February 4, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Locations

MO (1)