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

COVID-19 Clinical Trial

— PLASCOSSA  

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04372979
• Other study ID #: 2020-A01166-33
• Status: Terminated
• Phase: Phase 3
• Start date: September 14, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: April 2022
• Source: Direction Centrale du Service de Santé des Armées
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: June 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Transfusion of SARS-CoV-2 Convalescent Plasma.
2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.
• Transfusion of standard Plasma.
2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.

Locations

Country	Name	City	State
France	HIA Percy	Clamart
France	HIA Laveran	Marseille
France	HIA Bégin	Saint-Mandé
France	HIA Sainte Anne	Toulon

Sponsors (2)

Lead Sponsor	Collaborator
Direction Centrale du Service de Santé des Armées	University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival time without needs of a ventilator.	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.	Day 30
Secondary	Morbidity	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.	Day 15
Secondary	Morbidity	Difference of the SOFA (Sequential Organ Failure Assessment) mean score per patient between the two groups.	Day 30
Secondary	Mortality		Day 30
Secondary	Length of stay		Day 30
Secondary	Effect on viral pharyngeal specimen clearance	Quantitative SARS-CoV2 PCR carried out on pharyngeal specimen.	At inclusion and Day 7
Secondary	Effect on viral blood specimen clearance	Quantitative SARS-CoV2 PCR carried out on blood specimen.	At inclusion and Day 7
Secondary	Effect on hemostasis disorders	Effects on biological hemostasis parameters disorders.	At inclusion, Day 1 and every 48 hours
Secondary	Kinetics of appearance of neutralizing antibodies	Anti-SARS-Cov2 immunoglobulin G/A level and anti-SARS-Cov2 neutralizing antibody levels.	At inclusion, Day 7
Secondary	Transfusion endotheliopathy effect	Evolution of biological endotheliopathy parameters	At inclusion, Day 1, Day 7
Secondary	Transfusion biological Inflammation effect	Evaluation of biological dosages on inflammation effects	At inclusion, Day 1, Day 7
Secondary	Transfusion hemovigilance	Number of transfusion adverse events	30 days
Secondary	Decrease in the consumption of antibiotics		30 days

External Links

•   Anticoagulant treatment for the prevention of thrombotic risk in a patient hospitalized with COVID-19 and monitoring of hemostasis.
•   Coronavirus SARS-CoV-2 management of people at risk of severe forms (Haut Conseil de la Santé Publique; 2020)
•   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
•   Transfusion of therapeutic plasma: products, indications (Haute Autorité de Santé, France)