Covid-19 PneumoniaPhase 2NCT04622826
plasmApuane CoV-2 : Efficacy and Safety of Immune Covid-19 Plasma in Covid-19 Pneumonia in Non ITU Patients
A Phase 2 study testing immune plasma in people with Covid-19 Pneumonia, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.
Trial summary
Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19 Pneumonia
- What is being tested?
- immune plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2020to 31 Dec 2020
- Phase
- Phase 2
- 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
- > 18 years
- hospitalized patients with positive covid-19 swab with respiratory symptoms and CT confirmation of covid-19 chest disease admitted to non ITU recovery area.
- informed consent for plasma infusion
- informed consent to blood samples storing for future studies.
Who cannot join
- pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study
- immunoglobulin infusion in the last month
- contraindication to transfusion or previous adverse reaction
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale delle Apuane
Massa, Tuscany, 54033
mirko lombardi, +393478546332, mirkolombardi9@gmail.com
antonella vincenti, 003905854931, antonella.vincenti@uslnordovest.toscana.it
About this study
Official title: Studio in Aperto Sulla Somministrazione di Plasma di Paziente Convalescente da COVID- 19 a Paziente Con Polmonite COVID-19 Ospedalizzato, Non in Terapia Intensiva
Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms.
Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.
- Conditions
- Covid-19 Pneumonia
- Being tested
- immune plasma
- Keywords
- covid-19 pneumonia, convalescent plasma, hyperimmune plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immune plasmaBiological
immune covid 19 plasma infusion
| Study group | Role | What they receive |
|---|---|---|
| sequential immune plasma infused patients | Experimental | immune covid 19 plasma infusion Receives: Biological: immune plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
ITU admission
number of patients admitted to ITU after immune plasma transfusion
Measured: up to 30 days
administration of O2
O2 support will be monitored and reported in its various modes of administration (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, mechanical ventilation)
Measured: up to 30 days
hospital mortality
number of subject deaths
Measured: up to 90 days
immune plasma infusion adverse reaction
number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Measured: in the first 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start15 May 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 PneumoniaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mirko lombardi, Azienda USL Toscana Nord Ovest
- Investigators
- antonella vincenti, Principal investigator, ospedale delle Apuane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622826
- Sponsor's protocol ID
- ATNONordOvest
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studio in Aperto Sulla Somministrazione di Plasma di Paziente Convalescente da COVID- 19 a Paziente Con Polmonite COVID-19 Ospedalizzato, Non in Terapia Intensiva
- ClinicalTrials.gov ID
- NCT04622826
- Acronym / sponsor ID
- ATNONordOvest
- Conditions
- Covid-19 Pneumonia
- Keywords
- covid-19 pneumonia, convalescent plasma, hyperimmune plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 10 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.
Aim of the study is to verify the efficacy and safety of convalescent hyperimmune plasma infusion in hospitalized covid-19 patients non in ITU with pneumonia and respiratory symptoms within seven days from the beginning of symptoms.
Efficacy is evaluated by the number of patients who will improve their clinical condition and will not be admitted to ITU. .Safety is considered in relation to adverse reactions to plasma infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sequential immune plasma infused patients | Experimental | Biological: immune plasmaimmune covid 19 plasma infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years
- hospitalized patients with positive covid-19 swab with respiratory symptoms and CT confirmation of covid-19 chest disease admitted to non ITU recovery area.
- informed consent for plasma infusion
- informed consent to blood samples storing for future studies.
Key exclusion criteria (3 listed)
- pregnant or breastfeeding female patient or planning for a pregnancy in the period of the study
- contraindication to transfusion or previous adverse reaction
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 |
|---|---|---|
| immune plasmaimmune covid 19 plasma infusion | Biological | sequential immune plasma infused patients |
Primary outcome
ITU admission
Time frame: up to 30 days
number of patients admitted to ITU after immune plasma transfusion
administration of O2
Time frame: up to 30 days
O2 support will be monitored and reported in its various modes of administration (e.g. nasal cannula, high flow nasal cannula, noninvasive ventilation, mechanical ventilation)
hospital mortality
Time frame: up to 90 days
number of subject deaths
immune plasma infusion adverse reaction
Time frame: in the first 24-48 hours
number of participants with treatment-related adverse events as assessed by CTCAE v4.0"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
Related trials for Covid-19 Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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.
antonella vincenti principal investigator
ospedale delle Apuane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing immune plasma in people with Covid-19 Pneumonia, run by Azienda USL Toscana Nord Ovest 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 4 inclusion and 3 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 10 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 mirko lombardi (00393478546332, mirkolombardi9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ITU admission (time frame: up to 30 days). The study lists 4 primary outcomes in all. 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 10 Nov 2020.