Efficacy of Convalescent Plasma Therapy in the Early Care of COVID-19 Patients.
NCT ID: NCT04372979
Last Updated: 2022-04-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
PHASE3
Total Enrollment
18 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-09-14
Study Completion Date
2021-06-01
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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COVID-19
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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SARS-CoV-2 patients treated with convalescent plasma
Subjects will receive an intravenous injection of SARS-CoV-2 Convalescent Plasma.
Group Type
EXPERIMENTAL
Transfusion of SARS-CoV-2 Convalescent Plasma.
Intervention Type
DRUG
2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.
SARS-CoV-2 patients treated with standard plasma
Subjects will receive an intravenous injection of standard Plasma.
Group Type
ACTIVE_COMPARATOR
Transfusion of standard Plasma.
Intervention Type
DRUG
2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.
Interventions
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Transfusion of SARS-CoV-2 Convalescent Plasma.
2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.
Intervention Type
DRUG
Transfusion of standard Plasma.
2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
1. Age 18-90 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 or Troponin T \> 24.8 pg/mL
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 or Troponin T \> 24.8 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 \> 90 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
* Patients after 10 days from the start of symptoms
* Age \< 18 years and \> 90 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
90 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University Hospital, Grenoble
OTHER
Sponsor Role
collaborator
Direction Centrale du Service de Santé des Armées
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Nathalie KOULMANN
Role: STUDY_DIRECTOR
Direction Centrale du Service de Santé des Armées (DCSSA)
Catherine VERRET
Role: STUDY_DIRECTOR
Service de Santé des Armées-Direction de la Formation de la Recherche et de l'Innovation
Christophe MARTINAUD
Role: PRINCIPAL_INVESTIGATOR
Centre de Transfusion Sanguine des Armées
Jean-Luc BOSSON
Role: PRINCIPAL_INVESTIGATOR
Statistical and methodological investigator - Laboratoire TIMC UMR 5525 CNRS Equipe Themas
Locations
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HIA Percy
Clamart, , France
Site Status
HIA Laveran
Marseille, , France
Site Status
HIA Bégin
Saint-Mandé, , France
Site Status
HIA Sainte Anne
Toulon, , France
Site Status
Countries
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France
References
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BACKGROUND
Related Links
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https://sfar.org/download/traitement-anticoagulant-pour-la-prevention-du-risque-thrombotique-chez-un-patient-hospitalise-avec-covid-19-et-surveillance-de-lhemostase/
Anticoagulant treatment for the prevention of thrombotic risk in a patient hospitalized with COVID-19 and monitoring of hemostasis.
https://clinicaltrials.gov/ct2/show/NCT04323800
Efficacy and Safety Human Coronavirus Immune Plasma (HCIP) vs. Control (SARS-CoV-2 Non-immune Plasma) Among Adults Exposed to COVID-19 - Full Text View - ClinicalTrials.gov
https://www.has-sante.fr/jcms/c_1264081/fr/transfusion-de-plasma-therapeutique-produits-indications
Transfusion of therapeutic plasma: products, indications (Haute Autorité de Santé, France)
https://www.hcsp.fr/explore.cgi/avisrapportsdomaine?clefr=790
Coronavirus SARS-CoV-2 management of people at risk of severe forms (Haut Conseil de la Santé Publique; 2020)
Other Identifiers
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2020-A01166-33
Identifier Type: -
Identifier Source: org_study_id
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