Status:
TERMINATED
Efficacy of Convalescent Plasma Therapy in the Early Care of COVID-19 Patients.
Lead Sponsor:
Direction Centrale du Service de Santé des Armées
Collaborating Sponsors:
University Hospital, Grenoble
Conditions:
COVID-19
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
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 current...
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. Hospi...
Eligibility Criteria
Inclusion
- Age 18-90 years ;
- COVID-19 confirmed case ;
- Cases showing respiratory symptoms, checking at least one of the following criteria:
- Cough, dyspnea, respiratory rate \> 24 breaths/min
- Oxygen saturation \< 95% at rest in ambient air
- PaO2 \< 70mmHg
- Scanographic pulmonary compatible with COVID in the absence of any other etiology
- Risk of deterioration, checking at least one of the following comorbidity criteria :
- Chronic respiratory pathology
- Diabetes
- Cancer pathology
- Cardiovascular disease
- Chronic kidney failure
- Congenital or acquired immunodeficiency
- Cirrhosis at stage B
- Major sickle cell syndrome
- BMI \> 30 kg/m2
- OR one of the biological criteria :
- D-dimer 1 µg/mL,
- Lymphocytes \< 0.8 G/L,
- Ferritin \> 300 µg/L,
- Troponin I \> 11 pg/mL or Troponin T \> 24.8 pg/mL
Exclusion
- 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
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04372979
Start Date
September 14 2020
End Date
June 1 2021
Last Update
April 14 2022
Active Locations (4)
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1
HIA Percy
Clamart, France, 92140
2
HIA Laveran
Marseille, France, 13013
3
HIA Bégin
Saint-Mandé, France, 94160
4
HIA Sainte Anne
Toulon, France, 83000