Early Use of Hyperimmune Plasma in COVID-19 (COV-II-PLA)

March 30, 2022 updated by: Catherine Klersy

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Catherine Klersy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. Male or female adult patient ≥18 years of age at time of enrolment.
  3. Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen..
  4. 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)
  5. No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day
  6. Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
  7. The patient is not eligible in the Tsunami trial.

Exclusion Criteria:

  1. Participation in any other clinical trial of an experimental treatment for COVID-19.
  2. 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.
  3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
  4. Pregnancy
  5. Current documented and uncontrolled bacterial infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single
hyperimmune plasma with titre 1:80 or more
Other: hyperimmune plasma
plasma collected from convalescent Covid-19 donors with titre 1:80 or more

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical improvement (efficacy)
Time Frame: 28 days
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).
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
ventilation
Time Frame: Days: from 0 to 7, 14 and 28
Ventilator-free days
Days: from 0 to 7, 14 and 28
WHO (World Health Organization) scale
Time Frame: From day 0 to 28 days
WHO scale score reached. Minimum score is 0: unifected (no viral RNA detected); maximum score 10 (dead)
From day 0 to 28 days
SOFA (Sequential Organ Failure Assessment) score
Time Frame: Days: from 0 to 7, 14 and 28
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
Days: from 0 to 7, 14 and 28
naso-pharyngeal swab
Time Frame: Days: from 0 to 7, 14 and 28
Time to a negative SARS-COV2 naso-pharyngeal swab for upper respiratory tract or BAL/BRASP for lower respiratory
Days: from 0 to 7, 14 and 28
SARS-CoV2
Time Frame: 28 days
Log10 change in SARS-CoV2
28 days
P/F
Time Frame: Days: from 0 to 7, 14 and 28
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)
Days: from 0 to 7, 14 and 28
thrombosis
Time Frame: Days: from 0 to 7, 14 and 28
Occurrence of deep vein thrombosis or pulmonary embolism assessed using the most appropriate imaging approach
Days: from 0 to 7, 14 and 28
curarization
Time Frame: Days: from 0 to 7, 14 and 28
Total duration of mechanical ventilation, ventilatory weaning and curarisation in days
Days: from 0 to 7, 14 and 28
complication kidney
Time Frame: Days: from 0 to 7, 14 and 28
KDIGO score Kidney Disease: Improving Global Outcomes (KDIGO)
Days: from 0 to 7, 14 and 28
complication lung
Time Frame: Days: from 0 to 7, 14 and 28
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
Days: from 0 to 7, 14 and 28
Leucocytes
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: Leucocytes (x10^3/ul)
Days: from 0 to 7, 14 and 28
Lymphocytes
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: Lymphocytes (x10^3/ul)
Days: from 0 to 7, 14 and 28
C-reactive protein
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: C-reactive protein (mg/dL)
Days: from 0 to 7, 14 and 28
D-dimer
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: D-dimer (ug/L)
Days: from 0 to 7, 14 and 28
Troponin I (TnI)
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: TNI (ng/L)
Days: from 0 to 7, 14 and 28
PCTI (Procalcitonin) (ng/mL)
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: PCTI (Procalcitonin) (ng/mL)
Days: from 0 to 7, 14 and 28
Ferritin
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: Ferritin (ng/ml)
Days: from 0 to 7, 14 and 28
Albumin
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: Albumin (mg/dL)
Days: from 0 to 7, 14 and 28
LDH
Time Frame: Days: from 0 to 7, 14 and 28
Biological efficacy endpoints: LDH (mU/mL)
Days: from 0 to 7, 14 and 28
Lung Ultrasound Score (LUS)
Time Frame: Days: from 0 to 7, 14 , 28 and 6 months
Total Lung Ultrasound Score S score
Days: from 0 to 7, 14 , 28 and 6 months
ecmo
Time Frame: 28 days
Occurrence of ECMO implant
28 days
death
Time Frame: 28 days, 3 and 6 months
All cause mortality
28 days, 3 and 6 months
hospitalization
Time Frame: 28 days
days total hospitalization and of ICU hospitalization
28 days
Lung Function tests
Time Frame: 6 months
Lung Function tests
6 months
High resolution computed tomography (HRCT)
Time Frame: 6 months
HRCT findings of the thorax
6 months
Improvement mortality
Time Frame: 28 days
rate of clinical improvement and mortality between the patients in the study and the cohort enrolled in the local SMACORE registry
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catherine Klersy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondazione IRCCS Policlinico San Matteo di Pavia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francesco Mojoli, MD, Fondazione IRCCS Policlinico San Matteo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 100490/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

may be available upon motivated requesto to PI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings