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Efficacy of Convalescent Plasma Therapy in the Early Care of COVID-19 Patients. (PLASCOSSA)

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ClinicalTrials.gov Identifier: NCT04372979
Recruitment Status : Recruiting
First Posted : May 4, 2020
Last Update Posted : October 26, 2020
Sponsor:
Collaborator:
University Hospital, Grenoble
Information provided by (Responsible Party):
Direction Centrale du Service de Santé des Armées

Brief Summary:

COVID-19 (Corona Virus Disease 2019) hospitalized patients evolution is marked by the risk of worsening of the respiratory system during the second week of the disease. To date, treatments are currently being evaluated and none of them have shown to be effective in the care of these patients. The use of convalescent plasma is a passive immunotherapy. It has often been used in respiratory virus epidemic situations (during the 1918 or 2009 influenza pandemic, or during SARS-CoV-1 or MERS-CoV pandemic). Effects reported in literature are in favour of a beneficial impact of transfusion of these plasma without serious adverse effects reported.

PlasCoSSA is a randomized, controlled, triple-blinded, parallel clinical trial. This study tests the efficacy of convalescent plasma transfusion therapy in the early care of COVID-19 hospitalized patients outside intensive care units.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Transfusion of SARS-CoV-2 Convalescent Plasma. Drug: Transfusion of standard Plasma. Phase 3

Detailed Description:

During SARS-CoV-2 infection, two clinical-biological phases can be observed: an initial viral phase followed by an immunological phase whose onset has been associated with more severe prognosis. Hospitalized patients with comorbidities or clinical risk factors have a higher risk of respiratory functions deterioration and significant risk to need intensive care.

Early transfusion of convalescent plasma (2 units of 200-230 mL of apheresis plasma inactivated by amotosalen) would prevent this secondary worsening and reduce the risk to be transferred to intensive care, length of stay and mortality. Considering clinical and biological manifestations of the disease, including coagulation disorders, endothelial alterations, immunological disorders, it seems interesting to compare this convalescent plasma with a SARS-CoV-2 lacking antibodies plasma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation Of Efficacy Of COVID-19 Convalescent Plasma Versus Standard Plasma In The Early Care Of COVID-19 Patients Hospitalized Outside Intensive Care Units.
Actual Study Start Date : September 14, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: SARS-CoV-2 patients treated with convalescent plasma
Subjects will receive an intravenous injection of SARS-CoV-2 Convalescent Plasma.
Drug: Transfusion of SARS-CoV-2 Convalescent Plasma.
2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.

Active Comparator: SARS-CoV-2 patients treated with standard plasma
Subjects will receive an intravenous injection of standard Plasma.
Drug: Transfusion of standard Plasma.
2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.




Primary Outcome Measures :
  1. Survival time without needs of a ventilator. [ Time Frame: Day 30 ]
    Survival time without needs of ventilator, i.e. the time until oxygen supply (patient previously in ambient air), or an increase by more than 6L/min of O2 for more than 24 hours, or the use of non-invasive ventilation, or intubation, or death.


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: Day 15 ]
    The percentage of patients i) not hospitalized, without limitation of activities, ii) Not hospitalized, with activity limitation, iii) Hospitalized without oxygen therapy, iv) Hospitalized with oxygen therapy, v) Hospitalized with intensive oxygen therapy or non- invasive ventilation (NIV), vi) Hospitalized and intubated or on extracorporeal membrane oxygenation (ECMO), vii) Dead.

  2. Morbidity [ Time Frame: Day 30 ]
    Difference of the SOFA (Sequential Organ Failure Assessment) mean score per patient between the two groups.

  3. Mortality [ Time Frame: Day 30 ]
  4. Length of stay [ Time Frame: Day 30 ]
  5. Effect on viral pharyngeal specimen clearance [ Time Frame: At inclusion and Day 7 ]
    Quantitative SARS-CoV2 PCR carried out on pharyngeal specimen.

  6. Effect on viral blood specimen clearance [ Time Frame: At inclusion and Day 7 ]
    Quantitative SARS-CoV2 PCR carried out on blood specimen.

  7. Effect on hemostasis disorders [ Time Frame: At inclusion, Day 1 and every 48 hours ]
    Effects on biological hemostasis parameters disorders.

  8. Kinetics of appearance of neutralizing antibodies [ Time Frame: At inclusion, Day 7 ]
    Anti-SARS-Cov2 immunoglobulin G/A level and anti-SARS-Cov2 neutralizing antibody levels.

  9. Transfusion endotheliopathy effect [ Time Frame: At inclusion, Day 1, Day 7 ]
    Evolution of biological endotheliopathy parameters

  10. Transfusion biological Inflammation effect [ Time Frame: At inclusion, Day 1, Day 7 ]
    Evaluation of biological dosages on inflammation effects

  11. Transfusion hemovigilance [ Time Frame: 30 days ]
    Number of transfusion adverse events

  12. Decrease in the consumption of antibiotics [ Time Frame: 30 days ]


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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-80 years ;
  2. COVID-19 confirmed case ;
  3. Cases showing respiratory symptoms, checking at least one of the following criteria:

    1. Cough, dyspnea, respiratory rate > 24 breaths/min
    2. Oxygen saturation < 95% at rest in ambient air
    3. PaO2 < 70mmHg
    4. Scanographic pulmonary compatible with COVID in the absence of any other etiology
  4. Risk of deterioration, checking at least one of the following comorbidity criteria :

    1. Chronic respiratory pathology
    2. Diabetes
    3. Cancer pathology
    4. Cardiovascular disease
    5. Chronic kidney failure
    6. Congenital or acquired immunodeficiency
    7. Cirrhosis at stage B
    8. Major sickle cell syndrome
    9. BMI > 30 kg/m2

OR one of the biological criteria :

  1. D-dimer 1 µg/mL,
  2. Lymphocytes < 0.8 G/L,
  3. Ferritin > 300 µg/L,
  4. Troponin I > 11 pg/mL

Exclusion Criteria:

  • Patients admitted in intensive care within the first 6 hours of hospital care,
  • Patients after 10 days from the start of symptoms
  • Age < 18 years and > 80 years
  • Long-term oxygen-dependent patients (at home),
  • Decompensated chronic cardiac, respiratory, urological pathology
  • Patient refusing administration of blood products,
  • Allergic reaction to plasma products,
  • IgA deficiency,
  • Contraindication to transfusion
  • Ig transfusion within 30 days,
  • Patient currently participating to another clinical trial,
  • Pregnant women,
  • No affiliated to the social security,
  • Person deprived of liberty by a legal or administrative decision, person under guardianship

Information from the National Library of Medicine

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): NCT04372979


Contacts
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Contact: Christophe MARTINAUD, PU PH +33 141467241 christophe.martinaud@intradef.gouv.fr
Contact: Christophe RENARD +33 140514103 christophe1.renard@intradef.gouv.fr

Locations
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France
HIA Percy Recruiting
Clamart, France, 92140
Contact: Marc ALETTI       marc.aletti@intradef.gouv.fr   
Sub-Investigator: Jean-Paul HYRIEN         
Sub-Investigator: Damien RICARD         
Sub-Investigator: Katia AYMART         
HIA Laveran Not yet recruiting
Marseille, France, 13013
Contact: Hélène SAVINI       helene.savini@intradef.gouv.fr   
HIA Bégin Recruiting
Saint-Mandé, France, 94160
Contact: Cécile FICKO       cecile.ficko@intradef.gouv.fr   
Sub-Investigator: Marie GOMINET         
Sub-Investigator: Mathieu CABON         
Sub-Investigator: Pierre-Louis CONAN         
HIA Sainte Anne Recruiting
Toulon, France, 83000
Contact: Fabien DUTASTA       fabien.dutasta@intradef.gouv.fr   
Sub-Investigator: David DELARBRE         
Sponsors and Collaborators
Direction Centrale du Service de Santé des Armées
University Hospital, Grenoble
Investigators
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Study Director: Hervé FOEHRENBACH Direction Centrale du Service de Santé des Armées (DCSSA)
Study Director: Catherine VERRET Service de Santé des Armées-Direction de la Formation de la Recherche et de l'Innovation
Principal Investigator: Christophe MARTINAUD Centre de Transfusion Sanguine des Armées
Principal Investigator: Jean-Luc BOSSON Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas
Additional Information:
Publications:

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Responsible Party: Direction Centrale du Service de Santé des Armées
ClinicalTrials.gov Identifier: NCT04372979    
Other Study ID Numbers: 2020-A01166-33
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Direction Centrale du Service de Santé des Armées:
SARS-CoV-2
COVID 19
Convalescent plasma