Covid19COV-II-PLANCT04721236
Early Use of Hyperimmune Plasma in COVID-19
A study testing hyperimmune plasma in people with Covid19, run by Catherine Klersy at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- hyperimmune plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2020to 19 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Covid19
- Being tested
- hyperimmune plasma
- Keywords
- hyperimmune plasma, positive pressure respiratory support
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperimmune plasmaOther
plasma collected from convalescent Covid-19 donors with titre 1:80 or more
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | hyperimmune plasma with titre 1:80 or more Receives: Other: hyperimmune plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 days
Secondary outcomes (26)
ventilation
Ventilator-free days
Measured: Days: from 0 to 7, 14 and 28
WHO (World Health Organization) scale
WHO scale score reached. Minimum score is 0: unifected (no viral RNA detected); maximum score 10 (dead)
Measured: From day 0 to 28 days
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
Measured: Days: from 0 to 7, 14 and 28
naso-pharyngeal swab
Time to a negative SARS-COV2 naso-pharyngeal swab for upper respiratory tract or BAL/BRASP for lower respiratory
Measured: Days: from 0 to 7, 14 and 28
SARS-CoV2
Log10 change in SARS-CoV2
Measured: 28 days
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)
Measured: Days: from 0 to 7, 14 and 28
thrombosis
Occurrence of deep vein thrombosis or pulmonary embolism assessed using the most appropriate imaging approach
Measured: Days: from 0 to 7, 14 and 28
curarization
Total duration of mechanical ventilation, ventilatory weaning and curarisation in days
Measured: Days: from 0 to 7, 14 and 28
complication kidney
KDIGO score Kidney Disease: Improving Global Outcomes (KDIGO)
Measured: Days: from 0 to 7, 14 and 28
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
Measured: Days: from 0 to 7, 14 and 28
Leucocytes
Biological efficacy endpoints: Leucocytes (x10^3/ul)
Measured: Days: from 0 to 7, 14 and 28
Lymphocytes
Biological efficacy endpoints: Lymphocytes (x10^3/ul)
Measured: Days: from 0 to 7, 14 and 28
C-reactive protein
Biological efficacy endpoints: C-reactive protein (mg/dL)
Measured: Days: from 0 to 7, 14 and 28
D-dimer
Biological efficacy endpoints: D-dimer (ug/L)
Measured: Days: from 0 to 7, 14 and 28
Troponin I (TnI)
Biological efficacy endpoints: TNI (ng/L)
Measured: Days: from 0 to 7, 14 and 28
PCTI (Procalcitonin) (ng/mL)
Biological efficacy endpoints: PCTI (Procalcitonin) (ng/mL)
Measured: Days: from 0 to 7, 14 and 28
Ferritin
Biological efficacy endpoints: Ferritin (ng/ml)
Measured: Days: from 0 to 7, 14 and 28
Albumin
Biological efficacy endpoints: Albumin (mg/dL)
Measured: Days: from 0 to 7, 14 and 28
LDH
Biological efficacy endpoints: LDH (mU/mL)
Measured: Days: from 0 to 7, 14 and 28
Lung Ultrasound Score (LUS)
Total Lung Ultrasound Score S score
Measured: Days: from 0 to 7, 14 , 28 and 6 months
ecmo
Occurrence of ECMO implant
Measured: 28 days
death
All cause mortality
Measured: 28 days, 3 and 6 months
hospitalization
days total hospitalization and of ICU hospitalization
Measured: 28 days
Lung Function tests
Lung Function tests
Measured: 6 months
High resolution computed tomography (HRCT)
HRCT findings of the thorax
Measured: 6 months
Improvement mortality
rate of clinical improvement and mortality between the patients in the study and the cohort enrolled in the local SMACORE registry
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start19 Nov 2020
- Primary completion19 May 2021
- Study completion19 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a multiple center, one arm clinical trial
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Klersy
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Responsible party
- Sponsor-investigator, Catherine Klersy, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Francesco Mojoli, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721236
- Sponsor's protocol ID
- 100490/2020
- Acronym
- COV-II-PLA
- Status last verified
- Mar 2022
- First submitted
- 20 Jan 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: may be available upon motivated requesto to PI
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04721236
- Acronym / sponsor ID
- COV-II-PLA / 100490/2020
- Conditions
- Covid19
- Keywords
- hyperimmune plasma, positive pressure respiratory support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Catherine KlersyUniversity, hospital or other
- Collaborators
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2022 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a multiple center, one arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Other: hyperimmune plasmahyperimmune plasma with titre 1:80 or more |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperimmune plasmaplasma collected from convalescent Covid-19 donors with titre 1:80 or more | Other | Single |
Primary outcome
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).
26 secondary outcomes
ventilation
Time frame: Days: from 0 to 7, 14 and 28
WHO (World Health Organization) scale
Time frame: From day 0 to 28 days
SOFA (Sequential Organ Failure Assessment) score
Time frame: Days: from 0 to 7, 14 and 28
naso-pharyngeal swab
Time frame: Days: from 0 to 7, 14 and 28
SARS-CoV2
Time frame: 28 days
P/F
Time frame: Days: from 0 to 7, 14 and 28
thrombosis
Time frame: Days: from 0 to 7, 14 and 28
curarization
Time frame: Days: from 0 to 7, 14 and 28
complication kidney
Time frame: Days: from 0 to 7, 14 and 28
complication lung
Time frame: Days: from 0 to 7, 14 and 28
Leucocytes
Time frame: Days: from 0 to 7, 14 and 28
Lymphocytes
Time frame: Days: from 0 to 7, 14 and 28
C-reactive protein
Time frame: Days: from 0 to 7, 14 and 28
D-dimer
Time frame: Days: from 0 to 7, 14 and 28
Troponin I (TnI)
Time frame: Days: from 0 to 7, 14 and 28
PCTI (Procalcitonin) (ng/mL)
Time frame: Days: from 0 to 7, 14 and 28
Ferritin
Time frame: Days: from 0 to 7, 14 and 28
Albumin
Time frame: Days: from 0 to 7, 14 and 28
LDH
Time frame: Days: from 0 to 7, 14 and 28
Lung Ultrasound Score (LUS)
Time frame: Days: from 0 to 7, 14 , 28 and 6 months
ecmo
Time frame: 28 days
death
Time frame: 28 days, 3 and 6 months
hospitalization
Time frame: 28 days
Lung Function tests
Time frame: 6 months
High resolution computed tomography (HRCT)
Time frame: 6 months
Improvement mortality
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided. may be available upon motivated requesto to PI
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Mojoli, MD principal investigator
Fondazione IRCCS Policlinico San Matteo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperimmune plasma in people with Covid19, run by Catherine Klersy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (efficacy) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.