COVID-19Phase 2CoV-PlasGalNCT05578391
Passive Immunotherapy In Patients With SARS CoV-2
A Phase 2 study testing Convalescent plasma in people with COVID-19, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
Trial summary
Plasma from convalescent individuals (convalescent plasma, CP) has been used for more than a hundred years for the treatment of infectious diseases. Among patients with COVID-19, it has been used first, in patients with severe infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Convalescent plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 31 Mar 2021
- 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
- Patients with SARS-CoV-2 infection, confirmed by any validated microbiological technique, and with one or more symptoms associated with COVID-19 with ≤5 days of evolution and with an oxygen saturation ≥93% breathing room air.
- In addition, the patients had to present some risk factor for severe disease:
- Chronic heart failure (NYHA ≥ 2)
- Arterial hypertension under pharmacological treatment
- Chronic lung disease: COPD (bronchitis, emphysema or chronic obstruction) with dyspnoea at least on moderate exertion, or moderate-severe asthma (that required inhaled corticosteroids to control symptoms or had received systemic corticosteroids during the last year due to decompensation)
- Chronic renal failure (glomerular filtration rate <60 ml/min/1.73 m², by CKD- ILD)
- Diabetes mellitus requiring pharmacological treatment or obesity grade ≥ I (BMI ≥30 Kg/m2).
- Patients ≥65 years were included, regardless of other risk factors.
Who cannot join
- Duration of symptoms >5 days
- Dyspnoea at rest
- Need for supplemental oxygen to maintain O2 saturation >93%
- Solid neoplastic or haematologic disease (except skin cancer) with active treatment in the last 3 months before the onset of symptoms
- Patients under chronic corticosteroid treatment (equivalent to prednisone 10 mg/d for at least 28 days) or immunosuppressive treatment
- Decompensated liver cirrhosis
Show all 12Show fewer
- Participation in another clinical trial
- History of hypersensitivity to haematological derivatives
- Pregnancy or lactation,
- AST/ALT >5 times the upper limit of normal or at baseline in patients with chronic liver disease
- Any condition that in the opinion of the investigator limits participation in the study.
- Patients who had received monoclonal antibodies against SARS-CoV-2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PHASE II Clinical Trial Randomized And Controlled To Assess Need Of Oxygen On Day 14 After Administration Of Passive Immunotherapy In Patients Infected By SARS-CoV-2 With Risks Factors For Severe Disease
Plasma from convalescent individuals (convalescent plasma, CP) has been used for more than a hundred years for the treatment of infectious diseases. Among patients with COVID-19, it has been used first, in patients with severe infection. Although it is a safe treatment, it has not been possible to demonstrate a reduction in mortality in cases of acute respiratory distress syndrome.
The objective of the clinical trial is to evaluate the efficacy and safety of the early use (less than 5 days of symptoms) of CP in patients infected with SARS-CoV-2 with risk factors for severe disease.
The primary efficacy endpoint was the proportion of patients requiring oxygen therapy to maintain saturation >93% on day 14. Secondary objectives included, evaluation of the safety of the treatment, measured as the appearance of some adverse event related to the CP infusion; the evolution of COVID-19 symptoms and WHO progression scale status at day 14 and 28 after inclusion; the need for hospitalization due to progression of COVID-19. COVID-19 progression was considered as worsening of respiratory symptoms requiring oxygen therapy at some point. Finally, death from any cause was evaluated at 28 days, after inclusion in the study.
- Conditions
- COVID-19
- Being tested
- Convalescent 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.
Convalescent plasmaBiological
Admistration of one unit of convalescent plasma
| Study group | Role | What they receive |
|---|---|---|
| Convalescent plasma | Experimental | Not described Receives: Biological: Convalescent plasma |
| Conventional treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Requirement for oxygen therapy to maintain saturation >93%
Proportion of patients that need oxygen to achieve a saturation >93%
Measured: Day 14
Secondary outcomes (3)
Safety of the treatment with CP
Safety of CP treatment was evaluated by the appearance of any adverse event related to the infusion
Measured: Day 1
Evolution of COVID-19 symptoms
Proportion of patients with 1+2 WHO progression scale. This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.
- = Not hospitalized without limitation in activity (no symptoms)
- = Not hospitalized with limitation in activity (continued symptoms)
- = Hospitalized not on supplemental oxygen
- = Hospitalized on supplemental oxygen by mask or nasal prongs
- = Hospitalized on non-invasive ventilation or high flow nasal cannula
- = Hospitalized, intubated and mechanically ventilated
- = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy)
- = Death
Measured: Day 14 and 28
Requirement for hospitalization due to worsening of symptoms
Worsening of symptoms was evaluated using the WHO progression scale
- = Not hospitalized without limitation in activity (no symptoms)
- = Not hospitalized with limitation in activity (continued symptoms)
- = Hospitalized not on supplemental oxygen
- = Hospitalized on supplemental oxygen by mask or nasal prongs
- = Hospitalized on non-invasive ventilation or high flow nasal cannula
- = Hospitalized, intubated and mechanically ventilated
- = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy)
- = Death
Measured: Until day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Collaborators
- Health Knowledge Agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578391
- Sponsor's protocol ID
- CoV-PlasGal
- Acronym
- CoV-PlasGal
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE II Clinical Trial Randomized And Controlled To Assess Need Of Oxygen On Day 14 After Administration Of Passive Immunotherapy In Patients Infected By SARS-CoV-2 With Risks Factors For Severe Disease
- ClinicalTrials.gov ID
- NCT05578391
- Acronym / sponsor ID
- CoV-PlasGal / CoV-PlasGal
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Collaborators
- Health Knowledge Agency
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 13 Oct 2022 (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.
Plasma from convalescent individuals (convalescent plasma, CP) has been used for more than a hundred years for the treatment of infectious diseases. Among patients with COVID-19, it has been used first, in patients with severe infection. Although it is a safe treatment, it has not been possible to demonstrate a reduction in mortality in cases of acute respiratory distress syndrome.
The objective of the clinical trial is to evaluate the efficacy and safety of the early use (less than 5 days of symptoms) of CP in patients infected with SARS-CoV-2 with risk factors for severe disease.
The primary efficacy endpoint was the proportion of patients requiring oxygen therapy to maintain saturation >93% on day 14. Secondary objectives included, evaluation of the safety of the treatment, measured as the appearance of some adverse event related to the CP infusion; the evolution of COVID-19 symptoms and WHO progression scale status at day 14 and 28 after inclusion; the need for hospitalization due to progression of COVID-19. COVID-19 progression was considered as worsening of respiratory symptoms requiring oxygen therapy at some point. Finally, death from any cause was evaluated at 28 days, after inclusion in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Convalescent plasma | Experimental | Biological: Convalescent plasma |
| Conventional treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with SARS-CoV-2 infection, confirmed by any validated microbiological technique, and with one or more symptoms associated with COVID-19 with ≤5 days of evolution and with an oxygen saturation ≥93% breathing room air.
- Chronic heart failure (NYHA ≥ 2)
- Arterial hypertension under pharmacological treatment
- Chronic lung disease: COPD (bronchitis, emphysema or chronic obstruction) with dyspnoea at least on moderate exertion, or moderate-severe asthma (that required inhaled corticosteroids to control symptoms or had received systemic corticosteroids during the last year due to decompensation)
- Chronic renal failure (glomerular filtration rate <60 ml/min/1.73 m², by CKD- ILD)
Key exclusion criteria (12 listed)
- Duration of symptoms >5 days
- Dyspnoea at rest
- Need for supplemental oxygen to maintain O2 saturation >93%
- Solid neoplastic or haematologic disease (except skin cancer) with active treatment in the last 3 months before the onset of symptoms
- Patients under chronic corticosteroid treatment (equivalent to prednisone 10 mg/d for at least 28 days) or immunosuppressive treatment
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 |
|---|---|---|
| Convalescent plasmaAdmistration of one unit of convalescent plasma | Biological | Convalescent plasma |
Primary outcome
Requirement for oxygen therapy to maintain saturation >93%
Time frame: Day 14
Proportion of patients that need oxygen to achieve a saturation >93%
3 secondary outcomes
Safety of the treatment with CP
Time frame: Day 1
Evolution of COVID-19 symptoms
Time frame: Day 14 and 28
Requirement for hospitalization due to worsening of symptoms
Time frame: Until day 28
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 13 Oct 2022.
- Individual participant dataSharing planned: No
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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.
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 2 study testing Convalescent plasma in people with COVID-19, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
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 8 inclusion and 12 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 13 Oct 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 Spain. 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?
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?
Requirement for oxygen therapy to maintain saturation >93% (time frame: Day 14). 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 13 Oct 2022.