Covid19IMMUNO-COVID19NCT04614012
Hyperimmune Plasma for Patients With COVID-19
A study testing treated with hyperimmune plasma in people with Covid19, run by ANNA FALANGA at 1 site in Italy.
Trial summary
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- treated with hyperimmune plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jul 2020to 2 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >=18 yrs
- positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
- Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
- Polymerase chain reaction (PCR) positive
- signed informed consent unless unfeasible for the critical condition
Who cannot join
- proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
- consent denied
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Anna Falanga
Bergamo, 24127
Anna Falanga, afalanga@asst-pg23.it
About this study
Official title: The Use of Hyperimmune Plasma for the Treatment of COVID-19 Infection
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world.
Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. To date, no specific treatment has been proven to be effective. The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.
Read the detailed description
Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males and womens , age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.
Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.
- Conditions
- Covid19
- Being tested
- treated with hyperimmune plasma
- Keywords
- covid19, Hospitalized patients, Hyperimmune plasma
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treated with hyperimmune plasmaOther
Also called hyperimmune plasma
administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
| Study group | Role | What they receive |
|---|---|---|
| hyperimmune plasma | Experimental | treated with hyperimmune plasma Receives: Other: treated with hyperimmune plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
death from any cause
Measured: within 30 days
Secondary outcomes (5)
time to extubation
days since intubation
Measured: within 7 days
length of intensive care unit stay
days from entry to exit from ICU
Measured: within 7 days
length of hospitalization
days from entry to exit from hospital
Measured: within 30 days
immune response
neutralizing title
Measured: at days 1, 3 and 7
viral load
naso-pharyngeal swab and BAL
Measured: at days 1, 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start2 Jul 2020
- Primary completion2 Jul 2022 (estimated)
- Study completion2 Jul 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
- Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANNA FALANGA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ANNA FALANGA, A.O. Ospedale Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614012
- Sponsor's protocol ID
- IMMUNO-COVID19
- Acronym
- IMMUNO-COVID19
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Hyperimmune Plasma for the Treatment of COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04614012
- Acronym / sponsor ID
- IMMUNO-COVID19 / IMMUNO-COVID19
- Conditions
- Covid19
- Keywords
- covid19, Hospitalized patients, Hyperimmune plasma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ANNA FALANGAUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 2 Jul 2022 (estimated)
- Study completion
- 2 Jul 2022 (estimated)
- First posted
- 3 Nov 2020 (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 outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world.
Convalescent plasma or immunoglobulins have been used as a last resort to improve the survival rate of patients with SARS whose condition continued to deteriorate despite treatment with pulsed methylprednisolone. Moreover, several studies showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with convalescent plasma. Evidence shows that convalescent plasma from patients who have recovered from viral infections can be used effectively as a treatment of patients with active disease. To date, no specific treatment has been proven to be effective. The investigators plan to treat critical Covid-19 patients with hyperimmune plasma.
Detailed description
Apheresis from recovered donors will be performed with a cell separator device , with 500-600 mL of plasma obtained from each donor. Donors are males and womens , age 18 yrs or more, evaluated for transmissible diseases according to the italian law. Adjunctive tests will be for hepatitis A virus, hepatitis E virus and Parvovirus B-19. All donors will be tested for the Covid-19 neutralizing title. Each plasma bag obtained from plasmapheresis will be immediately divided in two units and frozen according to the national standards and stored separately.
Based on experience published in literature 250-300 mL of convalescent plasma will be used to treat each of the recruited patients at most 3 times over 5 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal assessment of COVID-19 patients treated with hyperimmune plasma
| Arm | Type | Receives |
|---|---|---|
| hyperimmune plasma | Experimental | Other: treated with hyperimmune plasmatreated with hyperimmune plasma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >=18 yrs
- positive for reverse transcription polymerase chain reaction (RT-PCR) severe acute respiratory syndrome (SARS)-CoV-2
- Acute respiratory distress syndrome (ARDS) moderate to severe, according to Berlin definition, lasting less than10 days
- Polymerase chain reaction (PCR) positive
- signed informed consent unless unfeasible for the critical condition
Key exclusion criteria (2 listed)
- proven hypersensitivity or allergic reaction to hemoderivatives or immunoglobulins
- consent denied
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 |
|---|---|---|
| treated with hyperimmune plasmaAlso: hyperimmune plasmaadministration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5 | Other | hyperimmune plasma |
Primary outcome
Death
Time frame: within 30 days
death from any cause
5 secondary outcomes
time to extubation
Time frame: within 7 days
length of intensive care unit stay
Time frame: within 7 days
length of hospitalization
Time frame: within 30 days
immune response
Time frame: at days 1, 3 and 7
viral load
Time frame: at days 1, 3 and 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treated with hyperimmune plasma in people with Covid19, run by ANNA FALANGA 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 5 inclusion and 2 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 3 Nov 2020. 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?
Contact Anna Falanga (+39 0352674776, afalanga@asst-ph23.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: within 30 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 3 Nov 2020.