Covid19 PneumoniaPhase 3NCT04535063
Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia
A Phase 3 study testing COVID19 convalescent plasma infusion in people with Covid19 Pneumonia, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 1 site in Argentina.
Trial summary
To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19 Pneumonia
- What is being tested?
- COVID19 convalescent plasma infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteArgentina
- Study dates
- 18 Apr 2020to 25 Feb 2021
- Phase
- Phase 3
- 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
- Adult patients ≥18, and non-pregnant women
- Severe or critical COVID-19 disease define by one or more of the following: blood oxygen saturation ≤ 94% on supplemental oxygen by nasal cannula at least 3 L/min, non-rebreathing mask (NRO2-mask) or on noninvasive ventilation; and pulmonary infiltrates with >50% increase within 24 to 48 hours in chest-X-ray or chest CT. Life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with PaO2 / FiO2 less than 300 mm Hg, septic shock, and/or multiple organ dysfunction.
- 10 days from the onset of symptoms or ≤ 7 days on mechanical ventilation. -
Who cannot join
- More than 10 days from symptoms onset or more than 7 days on mechanical ventilation
- Pregnancy
- Contraindication for plasma infusion because anaphylaxis history
- Patients with high risk of circulatory overload
- Limitation of therapeutic efforts
- Refractory shock define by norepinephrine dose more than 1 ug/k/min
- SOFA score more than 15 points at the moment of the protocol inclusion i Coagulopathy with requirements of plasma infusion
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Centro de Educación Médica e Investigaciones Clínicas
Buenos Aires, 1425
About this study
To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia
Read the detailed description
COVID-19 convalescent plasma will be infused to patients with severe COVID-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. Data will be compared with match control arm patients without plasma infusion
- Conditions
- Covid19 Pneumonia
- Being tested
- COVID19 convalescent plasma infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID19 convalescent plasma infusionBiological
intravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott)
| Study group | Role | What they receive |
|---|---|---|
| severe pneumonia arm | Other | patients with severe COVID19 pneumonia defined by: spontaneous breathing patients with respiratory failure requiring O2 nasal cannula more than 3 L/min or reservoir oxygen mask and SaO2 less than 95% or patients with critical pneumonia define by mechanical ventilation with less than 300 mmHg PaO2/FiO2 or shock or multi-organic dysfunction Receives: Biological: COVID19 convalescent plasma infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
28 days survival
number of subjects surviving at 28 days from plasma infusion
Measured: 28 days
Secondary outcomes (3)
efficacy of plasma infusion according to antibodies levels in the infuse bags
comparison of clinical efficacy according antibodies levels
Measured: 28 days
clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization
we will search if clinical efficacy is better when the earlier the infusion is decided
Measured: 28 days
change in clinical WHO ordinal scale from 1 to 10 points
WHO clinical scale is a measure of patient progression through the health-care system with 1 point asymptomatic patient and 10 patient dead
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start18 Apr 2020
- Primary completion30 Dec 2020
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo Valentini, Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535063
- Sponsor's protocol ID
- RValentini
- Status last verified
- Jul 2022
- First submitted
- 29 Aug 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: we will to share results to compare data with other studies with convalescent plasma infusion in COVID 19 patients after finishing our study
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma as Potential Therapy for Severe COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04535063
- Acronym / sponsor ID
- RValentini
- Conditions
- Covid19 Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centro de Educación Medica e Investigaciones Clínicas Norberto QuirnoUniversity, hospital or other
- Study start
- 18 Apr 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 1 Sep 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.
To determinate feasibility, safety and outcome with convalescent plasma in patients with severe COVID-19 penumonia
Detailed description
COVID-19 convalescent plasma will be infused to patients with severe COVID-19 pneumonia to determine feasibility, safety and clinical outcome efficacy by survival at-28 days. Data will be compared with match control arm patients without plasma infusion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients with severe COVID19 pneumonia will be recruited to a single arm therapy group with convalescent plasma from recovered patients
| Arm | Type | Receives |
|---|---|---|
| severe pneumonia arm | Other | Biological: COVID19 convalescent plasma infusionpatients with severe COVID19 pneumonia defined by: spontaneous breathing patients with respiratory failure requiring O2 nasal cannula more than 3 L/min or reservoir oxygen mask and SaO2 less than 95% or patients with critical pneumonia define by mechanical ventilation with less than 300 mmHg PaO2/FiO2 or shock or multi-organic dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients ≥18, and non-pregnant women
- Severe or critical COVID-19 disease define by one or more of the following: blood oxygen saturation ≤ 94% on supplemental oxygen by nasal cannula at least 3 L/min, non-rebreathing mask (NRO2-mask) or on noninvasive ventilation; and pulmonary infiltrates with >50% increase within 24 to 48 hours in chest-X-ray or chest CT. Life-threatening disease was defined as one or more of the following: respiratory failure on mechanical ventilation with PaO2 / FiO2 less than 300 mm Hg, septic shock, and/or multiple organ dysfunction.
Key exclusion criteria (7 listed)
- More than 10 days from symptoms onset or more than 7 days on mechanical ventilation
- Pregnancy
- Contraindication for plasma infusion because anaphylaxis history
- Patients with high risk of circulatory overload
- Limitation of therapeutic efforts
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 |
|---|---|---|
| COVID19 convalescent plasma infusionintravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott) | Biological | severe pneumonia arm |
Primary outcome
28 days survival
Time frame: 28 days
number of subjects surviving at 28 days from plasma infusion
3 secondary outcomes
efficacy of plasma infusion according to antibodies levels in the infuse bags
Time frame: 28 days
clinical efficacy of plasma infusion according to frame time from symptoms onset and hospitalization
Time frame: 28 days
change in clinical WHO ordinal scale from 1 to 10 points
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No. we will to share results to compare data with other studies with convalescent plasma infusion in COVID 19 patients after finishing our study
Related trials for Covid19 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COVID19 convalescent plasma infusion in people with Covid19 Pneumonia, run by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno at 1 site in Argentina.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 19 Jul 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 Argentina. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
28 days survival (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 19 Jul 2022.