Back to resultsEarly Use of Hyperimmune Plasma in COVID-19 (COV-II-PLA)
Primary Purpose
Covid19
Status
Active
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
hyperimmune plasma
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring hyperimmune plasma, positive pressure respiratory support
Eligibility Criteria
Inclusion Criteria:
- Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- Male or female adult patient ≥18 years of age at time of enrolment.
- Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen..
- Patient is hospitalized for COVID-19, is severely hypoxic with a P/F ≤ 200 while breathing room air or supplemental oxygen and requires positive pressure respiratory support, either non-invasive (helmet/mask CPAP or NIV) or invasive (endotracheal intubation and mechanical ventilation)
- No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day
- Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
- The patient is not eligible in the Tsunami trial.
Exclusion Criteria:
- Participation in any other clinical trial of an experimental treatment for COVID-19.
- In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
- Pregnancy
- Current documented and uncontrolled bacterial infection.
Sites / Locations
- Catherine Klersy
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single
Arm Description
hyperimmune plasma with titre 1:80 or more
Outcomes
Primary Outcome Measures
Clinical improvement (efficacy)
Clinical improvement is obtained when a patient decreases his/her score by 2 points on the ten-category ordinal WHO scale or is discharged alive from the hospital, whichever comes first. The WHO scale is chosen in accordance with the "Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme" recently published in Lancet Infectious Diseases (WHO, 2020).
Secondary Outcome Measures
ventilation
Ventilator-free days
WHO (World Health Organization) scale
WHO scale score reached. Minimum score is 0: unifected (no viral RNA detected); maximum score 10 (dead)
SOFA (Sequential Organ Failure Assessment) score
Sequential Organ Failure Assessment Score (SOFA score). This score is used to determine the extent of a person's organ function or rate of failure, from 0 to 24, with severity increasing with higher the scores
naso-pharyngeal swab
Time to a negative SARS-COV2 naso-pharyngeal swab for upper respiratory tract or BAL/BRASP for lower respiratory
SARS-CoV2
Log10 change in SARS-CoV2
P/F
P/F ratio. P/F is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage)
thrombosis
Occurrence of deep vein thrombosis or pulmonary embolism assessed using the most appropriate imaging approach
curarization
Total duration of mechanical ventilation, ventilatory weaning and curarisation in days
complication kidney
KDIGO score Kidney Disease: Improving Global Outcomes (KDIGO)
complication lung
Occurrence of ventilator-acquired pneumonia - Radiological and clinical context associated with a bacteriological sampling in culture of tracheal secretions, bronchiolar-alveolar lavage or a protected distal sampling
Leucocytes
Biological efficacy endpoints: Leucocytes (x10^3/ul)
Lymphocytes
Biological efficacy endpoints: Lymphocytes (x10^3/ul)
C-reactive protein
Biological efficacy endpoints: C-reactive protein (mg/dL)
D-dimer
Biological efficacy endpoints: D-dimer (ug/L)
Troponin I (TnI)
Biological efficacy endpoints: TNI (ng/L)
PCTI (Procalcitonin) (ng/mL)
Biological efficacy endpoints: PCTI (Procalcitonin) (ng/mL)
Ferritin
Biological efficacy endpoints: Ferritin (ng/ml)
Albumin
Biological efficacy endpoints: Albumin (mg/dL)
LDH
Biological efficacy endpoints: LDH (mU/mL)
Lung Ultrasound Score (LUS)
Total Lung Ultrasound Score S score
ecmo
Occurrence of ECMO implant
death
All cause mortality
hospitalization
days total hospitalization and of ICU hospitalization
Lung Function tests
Lung Function tests
High resolution computed tomography (HRCT)
HRCT findings of the thorax
Improvement mortality
rate of clinical improvement and mortality between the patients in the study and the cohort enrolled in the local SMACORE registry
Full Information
NCT ID
NCT04721236
First Posted
January 20, 2021
Last Updated
March 30, 2022
Sponsor
Catherine Klersy
Collaborators
Fondazione IRCCS Policlinico San Matteo di Pavia
1. Study Identification
Unique Protocol Identification Number
NCT04721236
Brief Title
Early Use of Hyperimmune Plasma in COVID-19
Acronym
COV-II-PLA
Official Title
COVID-19 Wave II Study for Assessing the Early Use of Hyperimmune Plasma for the Treatment of COVID-19 Patients Needing Non-invasive or Invasive Mechanical Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2020 (Actual)
Primary Completion Date
May 19, 2021 (Actual)
Study Completion Date
May 19, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Catherine Klersy
Collaborators
Fondazione IRCCS Policlinico San Matteo di Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study assesses the efficacy of early administration of hyperimmune plasma in covid-19 patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in the WHO scale
Detailed Description
Patients who satisfy eligibility criteria and in particular have started positive pressure respiratory support not more than no more than 48 hours are administered 200 to 300 ml in 2 or 3 times administered over a time window of 5 days. . Plasma titration will depend on the availability in the local Plasma Bank; any titre ≥ 1:80 will be acceptable. primary endpoint will be assessed at 28 days; vital status will be further investigated at 3 and 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
hyperimmune plasma, positive pressure respiratory support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a multiple center, one arm clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single
Arm Type
Experimental
Arm Description
hyperimmune plasma with titre 1:80 or more
Intervention Type
Other
Intervention Name(s)
hyperimmune plasma
Intervention Description
plasma collected from convalescent Covid-19 donors with titre 1:80 or more
Primary Outcome Measure Information:
Title
Clinical improvement (efficacy)
Description
Clinical improvement is obtained when a patient decreases his/her score by 2 points on the ten-category ordinal WHO scale or is discharged alive from the hospital, whichever comes first. The WHO scale is chosen in accordance with the "Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme" recently published in Lancet Infectious Diseases (WHO, 2020).
Time Frame
28 days
Secondary Outcome Measure Information:
Title
ventilation
Description
Ventilator-free days
Time Frame
Days: from 0 to 7, 14 and 28
Title
WHO (World Health Organization) scale
Description
WHO scale score reached. Minimum score is 0: unifected (no viral RNA detected); maximum score 10 (dead)
Time Frame
From day 0 to 28 days
Title
SOFA (Sequential Organ Failure Assessment) score
Description
Sequential Organ Failure Assessment Score (SOFA score). This score is used to determine the extent of a person's organ function or rate of failure, from 0 to 24, with severity increasing with higher the scores
Time Frame
Days: from 0 to 7, 14 and 28
Title
naso-pharyngeal swab
Description
Time to a negative SARS-COV2 naso-pharyngeal swab for upper respiratory tract or BAL/BRASP for lower respiratory
Time Frame
Days: from 0 to 7, 14 and 28
Title
SARS-CoV2
Description
Log10 change in SARS-CoV2
Time Frame
28 days
Title
P/F
Description
P/F ratio. P/F is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage)
Time Frame
Days: from 0 to 7, 14 and 28
Title
thrombosis
Description
Occurrence of deep vein thrombosis or pulmonary embolism assessed using the most appropriate imaging approach
Time Frame
Days: from 0 to 7, 14 and 28
Title
curarization
Description
Total duration of mechanical ventilation, ventilatory weaning and curarisation in days
Time Frame
Days: from 0 to 7, 14 and 28
Title
complication kidney
Description
KDIGO score Kidney Disease: Improving Global Outcomes (KDIGO)
Time Frame
Days: from 0 to 7, 14 and 28
Title
complication lung
Description
Occurrence of ventilator-acquired pneumonia - Radiological and clinical context associated with a bacteriological sampling in culture of tracheal secretions, bronchiolar-alveolar lavage or a protected distal sampling
Time Frame
Days: from 0 to 7, 14 and 28
Title
Leucocytes
Description
Biological efficacy endpoints: Leucocytes (x10^3/ul)
Time Frame
Days: from 0 to 7, 14 and 28
Title
Lymphocytes
Description
Biological efficacy endpoints: Lymphocytes (x10^3/ul)
Time Frame
Days: from 0 to 7, 14 and 28
Title
C-reactive protein
Description
Biological efficacy endpoints: C-reactive protein (mg/dL)
Time Frame
Days: from 0 to 7, 14 and 28
Title
D-dimer
Description
Biological efficacy endpoints: D-dimer (ug/L)
Time Frame
Days: from 0 to 7, 14 and 28
Title
Troponin I (TnI)
Description
Biological efficacy endpoints: TNI (ng/L)
Time Frame
Days: from 0 to 7, 14 and 28
Title
PCTI (Procalcitonin) (ng/mL)
Description
Biological efficacy endpoints: PCTI (Procalcitonin) (ng/mL)
Time Frame
Days: from 0 to 7, 14 and 28
Title
Ferritin
Description
Biological efficacy endpoints: Ferritin (ng/ml)
Time Frame
Days: from 0 to 7, 14 and 28
Title
Albumin
Description
Biological efficacy endpoints: Albumin (mg/dL)
Time Frame
Days: from 0 to 7, 14 and 28
Title
LDH
Description
Biological efficacy endpoints: LDH (mU/mL)
Time Frame
Days: from 0 to 7, 14 and 28
Title
Lung Ultrasound Score (LUS)
Description
Total Lung Ultrasound Score S score
Time Frame
Days: from 0 to 7, 14 , 28 and 6 months
Title
ecmo
Description
Occurrence of ECMO implant
Time Frame
28 days
Title
death
Description
All cause mortality
Time Frame
28 days, 3 and 6 months
Title
hospitalization
Description
days total hospitalization and of ICU hospitalization
Time Frame
28 days
Title
Lung Function tests
Description
Lung Function tests
Time Frame
6 months
Title
High resolution computed tomography (HRCT)
Description
HRCT findings of the thorax
Time Frame
6 months
Title
Improvement mortality
Description
rate of clinical improvement and mortality between the patients in the study and the cohort enrolled in the local SMACORE registry
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
Male or female adult patient ≥18 years of age at time of enrolment.
Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen..
Patient is hospitalized for COVID-19, is severely hypoxic with a P/F ≤ 200 while breathing room air or supplemental oxygen and requires positive pressure respiratory support, either non-invasive (helmet/mask CPAP or NIV) or invasive (endotracheal intubation and mechanical ventilation)
No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day
Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
The patient is not eligible in the Tsunami trial.
Exclusion Criteria:
Participation in any other clinical trial of an experimental treatment for COVID-19.
In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
Pregnancy
Current documented and uncontrolled bacterial infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Mojoli, MD
Organizational Affiliation
Fondazione IRCCS Policlinico San Matteo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catherine Klersy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
may be available upon motivated requesto to PI
Learn more about this trial
Early Use of Hyperimmune Plasma in COVID-19
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