Blood Plasma TherapyNCT04365439
Convalescent Plasma for COVID-19
A study testing Blood plasma in people with Blood Plasma Therapy and COVID, run by Enos Bernasconi at 1 site in Switzerland.
Trial summary
The purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess: the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment; the in-depth analysis of immunological parameters in the donors and in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Blood Plasma Therapy, COVID
- What is being tested?
- Blood plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jul 2020to 30 Jun 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized adult patients 18 - 75 y.o. with confirmed COVID-19 infection by nasopharyngeal swab;
- radiologically confirmed pneumonia;
- SpO2 > 92o/o and < 96% (room air);
- ongoing thromboembolic prophylaxis.
Who cannot join
- Participation to another COVID-19 trial;
- severe COVID-19 disease (SpO2 < 93o/o in room air);
- severe allergic transfusion reactions or anaphylaxis in the patient history;
- documented lgA deficiency;
- unstable heart disease with signs of circulatory overload;
- malignancies or other concomitant diseases with poor short-term prognosis;
- pregnancy.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale Locarno
Locarno, Canton Ticino, CH-6600
About this study
Official title: Convalescent Plasma for the Treatment of Moderate-severe COVID-19: A Proof-of-principle Study
The purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess:
- the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment;
- the in-depth analysis of immunological parameters in the donors and in recipient before and after treatment;
- the impact of plasma transfusion on the reduction of viral load and inflammation
- safety and tolerability
- clinical efficacy
- Conditions
- Blood Plasma Therapy, COVID
- Being tested
- Blood plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood plasmaBiological
Convalescent plasma after COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Convalescent plasma | Experimental | Convalescent plasma from patients after COVID-19 Receives: Biological: Blood plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors
Measured: At plasma donation
Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma
Measured: Change from baseline at day 21
Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1)
Measured: Change from baseline at day 7
Viral load decay in the recipient after plasma transfusion with semiquantitative assessment of nasopharyngeal swabs
Semiquantitative measure of viral load by rtPCR for SARS-CoV-2 by nasopharyngeal swabs, at diagnosis and on day 1,3,7
Measured: Change from day of diagnosis at day 1
Secondary outcomes (2)
Number of patients with improvement in the 7-points Ordinal Scale
7-point ordinal scale measure on day 0 (Baseline), day 1, 3 and 7 after plasma transfusion
Measured: At day 7
Proportion of patients with adverse events, severity of adverse events
AE will be assessed by the DAIDS scale on day 1, 3, 7 and 21. Relatedness with plasma transfusion will also be reported.
Measured: At day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start20 Jul 2020
- Primary completion20 Dec 2020
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood Plasma TherapyStudies 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enos Bernasconi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enos Bernasconi, Ente Ospedaliero Cantonale, Bellinzona
- Investigators
- Stefano Fontana, M.D., Principal investigator, Servizio Trasfusionale, Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365439
- Sponsor's protocol ID
- 2020-00895
- Status last verified
- Mar 2021
- First submitted
- 18 Apr 2020
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
PubMed 32219428
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma for the Treatment of Moderate-severe COVID-19: A Proof-of-principle Study
- ClinicalTrials.gov ID
- NCT04365439
- Acronym / sponsor ID
- 2020-00895
- Conditions
- Blood Plasma Therapy, COVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Enos BernasconiUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 28 Apr 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 purpose of this proof of concept study is to provide COVID-19 convalescent plasma to patients with moderate to severe COVID-19 and assess:
- the titer of anti-COVID-19 antibodies in the donors and in the patients before and after treatment;
- the in-depth analysis of immunological parameters in the donors and in recipient before and after treatment;
- the impact of plasma transfusion on the reduction of viral load and inflammation
- safety and tolerability
- clinical efficacy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Convalescent plasma | Experimental | Biological: Blood plasmaConvalescent plasma from patients after COVID-19 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized adult patients 18 - 75 y.o. with confirmed COVID-19 infection by nasopharyngeal swab;
- radiologically confirmed pneumonia;
- SpO2 > 92o/o and < 96% (room air);
- ongoing thromboembolic prophylaxis.
Key exclusion criteria (7 listed)
- Participation to another COVID-19 trial;
- severe COVID-19 disease (SpO2 < 93o/o in room air);
- severe allergic transfusion reactions or anaphylaxis in the patient history;
- documented lgA deficiency;
- unstable heart disease with signs of circulatory overload;
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 |
|---|---|---|
| Blood plasmaConvalescent plasma after COVID-19 | Biological | Convalescent plasma |
Primary outcome
Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors
Time frame: At plasma donation
Change in titers of anti-SARS-CoV-2 antibodies in patients' plasma
Time frame: Change from baseline at day 21
Change in inflammatory cytokines concentration (e.g. IL-6, HMGB1)
Time frame: Change from baseline at day 7
Viral load decay in the recipient after plasma transfusion with semiquantitative assessment of nasopharyngeal swabs
Time frame: Change from day of diagnosis at day 1
Semiquantitative measure of viral load by rtPCR for SARS-CoV-2 by nasopharyngeal swabs, at diagnosis and on day 1,3,7
2 secondary outcomes
Number of patients with improvement in the 7-points Ordinal Scale
Time frame: At day 7
Proportion of patients with adverse events, severity of adverse events
Time frame: At day 21
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Background: PubMed 32219428Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, Wang F, Li D, Yang M, Xing L, Wei J, Xiao H, Yang Y, Qu J, Qing L, Chen L, Xu Z, Peng L, Li Y, Zheng H, Chen F, Huang K, Jiang Y, Liu D, Zhang Z, Liu Y, Liu L. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma. JAMA. 2020 Apr 28;323(16):1582-1589. doi: 10.1001/jama.2020.4783.
- 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.
Stefano Fontana, M.D. principal investigator
Servizio Trasfusionale, Lugano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood plasma in people with Blood Plasma Therapy and COVID, run by Enos Bernasconi at 1 site in Switzerland.
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 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: status not confirmed, as of the sponsor's last update on 29 Mar 2021. 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 Switzerland. 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?
Titers of anti-SARS-CoV-2 antibodies in the plasma derived from convalescent donors (time frame: At plasma donation). 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?
On the ClinicalTrials.gov record for NCT04365439, which also lists 1 linked publication.
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 29 Mar 2021.