Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation (CONFIDENT)
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|ClinicalTrials.gov Identifier: NCT04558476|
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : May 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19 Mechanical Ventilation Complication Corona Virus Infection Respiratory Failure SARS (Severe Acute Respiratory Syndrome)||Biological: Convalescent Plasma Other: Standard of Care||Phase 2|
Design : multicenter randomized openlabel, phase II trial.
Number of patients to include : 500 (250 with plasma, 250 without plasma).
The principal objective is to assess the efficacy of the treatment to reduce day-28 mortality in patients with SARS-CoV-2 pneumonia who require mechanical ventilation.
Hypothesis: Passive immunization with plasma collected from patients having contracted COVID-19 and developed specific antibodies may alleviate symptoms and viral load of SARS-CoV-2 and reduce mortality.
The patients will receive currently accepted standard of care for both COVID-19 and usual organ dysfunctions observed in such cases. half the patients will be administered either Convalescent plasma, depending on the randomization process. All patients will be followed-up for one year after inclusion. The study will be considered either positive or negative, based on the principal objective. This means that the product convalescent plasme will be considered effective if mortality at day 28 is lower is patients treated with convalescent plasma than without it. The follow-up will allow to assess a series of secondary objectives, addressing the evolution of organ failures, viral infection, inflammatory response and long-term physical of psychological impact of COVID-19. Interim analyses will be performed every 100 patients included in order to stop the trial if an exceptionally good or bad result is observed, to prevent using or not using the product appropriately in further patients. These analyses will be supervised by an independent committee.
The choice to include only those patients under mechanical ventilation for severe respiratory failure makes this study different from other trials testing convalescent plasma, as most trial include less severe patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Randomized Trial to Assess the Efficacy of CONvalescent Plasma Therapy in Patients With Invasive COVID-19 and Acute Respiratory Failure Treated With Mechanical Ventilation: the CONFIDENT Trial|
|Actual Study Start Date :||September 1, 2020|
|Estimated Primary Completion Date :||September 1, 2022|
|Estimated Study Completion Date :||September 1, 2022|
Experimental: Convalescent Plasma
2 units of plasma ( 400-500ml) from 2 different donnors duration of treatment =2 h
Biological: Convalescent Plasma
2 units of convalescent plasma
Standard of care
Standard of care according the last gold standards
Other: Standard of Care
- Vital status [ Time Frame: at day 28 ]dead or alive
- day 90 mortality [ Time Frame: at day 90 ]dead or alive
- number of ventilator-free days at day 28 [ Time Frame: at day 28 ]to assess the ventilator free days
- number of renal replacement therapy free days at day 28 [ Time Frame: at day 28 ]to assess the number of renal replacement therapy free days
- number of vasopressors free-days at day 28 [ Time Frame: at day 28 ]to assess the number of vasopressors free-days
- use of ECMO before day 28 [ Time Frame: till day 28 ]to assess if ECMO was required
- value of the SOFA score at days 7, 14 and 28 [ Time Frame: Day 1, 7, 14, 28 ]to assess the value of SOFA score
- changes in SOFA scores (delta SOFA) over 7, 14 and 28 days [ Time Frame: Day 7, 14 and 28 days ]to assess the changes in SOFA scores (delta SOFA)
- assessment of the SARS-CoV-2 viral load [ Time Frame: Days 7, 14 and 28 ]assessment of the SARS-CoV-2 viral load, expressed as cycle threshold,  in the tracheal aspirates (for intubated patients) or nasopharyngeal swabs (for extubated patients) at days 7, 14 and 28
- blood C reactive protein (CRP) concentration [ Time Frame: Days 7, 14 and 28 ]to assess the concentrations of C reactive protein (CRP)
- ferritin concentration [ Time Frame: Days 7, 14 and 28 ]to assess the concentration of ferritin
- lymphocyte count [ Time Frame: Days 7, 14 and 28 ]to assess the count of lymphocyte
- length of stay in the acute care hospital [ Time Frame: through study completion, 1 year ]to assess the lenght of stay in the acute care
- location of the patient [ Time Frame: Day 90 ]to assess the location of the patient : acute care hospital, post acute care hospital, long-term residency, home
- Katz Index of independence in Activity Day Living functional score [ Time Frame: Day 90 and 365 ]to assess the Activity Day Living functional Min value: 0 = Low (patient very dependent) Max value: 6 = High (patient independent)
- Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Day 90 and 365 ]to evaluate the anxiety-depression For each item 0-7 : Normal 8-10 : Bordeline abnormal (borderline case) 11-21 : Abnormal case
- Quality of life scale EQ-5D-5L [ Time Frame: Day 90 and 365 ]
The EQ-5D-5L is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.
The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.
- Transfusion related adverse events [ Time Frame: till 28 days ]to assess the transfusion related adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558476
|Contact: Benoit Misset, MD,PhDemail@example.com|
|Contact: Axelle Bertand||003242843975||Axelle.Bertrand@chuliege.be|