Covid19Phase 3NCT04836260
Preemptive Use of Convalescent Plasma for High-risk Patients With COVID-19
A Phase 3 study testing SARS-CoV-2 convalescent plasma in people with Covid19 and Immuno-Deficiency, run by University Hospital, Geneva at 4 sites in Switzerland.
Trial summary
Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Immuno-Deficiency, Old Age; Debility
- What is being tested?
- SARS-CoV-2 convalescent plasma
- How many people
- 100 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 8 Apr 2021to 31 Dec 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
- Immunocompromised patients defined as
- Solid organ transplant ≤1 year before inclusion or treated for acute or chronic rejection episode or
- Allogeneic stem cell transplant recipients ≤2 years before inclusion or treated for acute GvHD ≥grade 2 or chronic moderate-severe GvHD or
- Active solid or haematological oncological disease with curative perspectives or
- HIV infection with CD4<350 or
- Hypogammaglobulinemia and other severe genetic immunological defect or
Show all 26Show fewer
- Auto-immune disease with biological immunosuppressive treatment* or
- Other significant immunosuppressive condition such as IgG <6, treamtent with Rituximab or other biological lymphopenic treatment AND
- Age ≥ 18 years old and
- 2 distinct ABO group determination and
- Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 7 days and days post symptom onset (DPOS) ≤ 7 days at inclusion and/or
- No oxygen requirement (WHO 8 ordinal scale < 4): asymptomatic, mild or moderate disease, or O2 saturation ≥ 90% at room temperature and
- Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)
- RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of infusion (highly suggested but not necessary)
- Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least one co-existing condition
- Arterial hypertension under pharmacological treatment
- Diabetes in treatment
- Obesity (BMI ≥ 30 kg/m2)
- Chronic obstructive pulmonary disease stade GOLD ≥2
- Respiratory insufficiency due to any pneumopathy or neurologic disease.
- Cardiovascular disease as defined by either known coronary heart disease, history of ischemic or hemorrhagic stroke or cardiac insufficiency (ejection fraction <40%)
- Chronic kidney disease (GFR<60 ml/min) AND
- 2 distinct ABO group determination and
- Positive RT-PCR for SARS-CoV-2 on a respiratory tract sample of ≤ 3 days and days post symptom onset (DPOS) ≤ 3 days at inclusion or RT-PCR on a respiratory tract sample with CT value<20 or ascending kinetics at the time of perfusion and
- No additional oxygen requirement compared to baseline (WHO 8 ordinal scale < 4): asymptomatic, mild or moderate disease and
- Compatible ABO donor with neutralizing antibodies (NTAB) ≥1 :160 or equivalent according to predefined antibody commercial assays cut-offs (see Study procedures)
Who cannot join
- Seroconversion at the time of inclusion
- Palliative care
- No signed informed consent
- History of previous transfusion-related Grade 3 adverse event according to Swissmedic definitions
- Disseminated intravascular coagulopathy (depending on specialist evaluation)
- Uncontrolled acute hypervolemia
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites, 4 recruiting
- Recruiting
Universitätsspital Basel
Basel, 4031
Nina Khanna, MD, +41613287325, nina.khanna@usb.ch
Maja Weisser, MD, +413286742, maja.weisser@usb.ch
- Recruiting
HFR-Fribourg Hôpital Cantonal
Fribourg, 1708
Véronique Erard, MD, +41 26 3060836, Veronique.erard@h-fr.ch
Emmanuel Levrat, MD
- Recruiting
Geneva University Hospitals
Geneva, 1205
Diem-Lan Vu Cantero, MD, PhD, +41795535512, diem-lan.vu@hcuge.ch
Laurent Kaiser, MD, +41795533420, laurent.kaiser@hcuge.ch
- Recruiting
Ospedale Regionale di Lugano
Lugano, 6900
Enos Bernasconi, MD, +41918116022, Enos.Bernasconi@eoc.ch
Stefano Fontana, MD
About this study
Official title: Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial
Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population.
The aim of the present study is to offer convalescent plasma therapy to immunocompromised patients and older adults in the early phase of a SARS-Cov-2 infection in order to accelerate viral clearance and prevent complication
Read the detailed description
This is an open-label non-controlled, non-randomised interventional study. Study population consist in immunocompromised patients and older adults with or without co-morbidities.
Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 or equivalent at maximum 3-7 days after diagnosis by RT-PCR or symptom onset or if having mild-moderate disease (WHO scale <4).
Patients will be followed-up up to 28 days to assess progression to WHO scale 4 disease, and 28-days mortality and viral load kinetics.
- Conditions
- Covid19, Immuno-Deficiency, Old Age; Debility
- Being tested
- SARS-CoV-2 convalescent plasma
- Keywords
- SARS-CoV-2, Convalescent plasma
- Medical subject headings
- COVID-19, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 convalescent plasmaDrug
Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 at maximum 3-7 days after diagnosis by RT-PCR or symptom onset. A second unit of plasma from a different donor can be proposed 24h after the first unit if immunocompromised and/or the patient received less than 3-5ml/kg of plasma volume. Additional units can be exceptionnally infused, at the investigator discretion.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Measured: 7 days after plasma infusion
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Measured: 14 days after plasma infusion
Proportion of death
Measured: 28 days after plasma infusion
Secondary outcomes (2)
Proportion of patients with cleared nasopharyngeal viral load
Cleared viral load is defined as CT value ≥30
Measured: 7 days after plasma infusion
Proportion of patients with cleared nasopharyngeal viral load
Cleared viral load is defined as CT value ≥30
Measured: 14 days after plasma infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start8 Apr 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (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.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- open-label non-controlled, non-randomised interventional study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Ospedale Regionale di Lugano, Hôpital Fribourgeois
- Responsible party
- Principal investigator, Diem-Lan Vu, University Hospital, Geneva
- Investigators
- Laurent Kaiser, MD, Principal investigator, University Hospital, GenevaEnos Bernasconi, MD, Principal investigator, Ospedale Regionale di LuganoVéronique Erard, MD, Principal investigator, HFR-Fribourg Hôpital CantonalMaja Weisser, MD, Principal investigator, Klinik Infektiologie & Spitalhygiene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836260
- Sponsor's protocol ID
- 2020-02989
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Use of Convalescent Plasma for High-risk Patients With SARS-CoV-2 Infection: Phase III-IV Non-controlled Non-randomised Swiss Multicentric Trial
- ClinicalTrials.gov ID
- NCT04836260
- Acronym / sponsor ID
- 2020-02989
- Conditions
- Covid19, Immuno-Deficiency, Old Age; Debility
- Keywords
- SARS-CoV-2, Convalescent plasma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- University Hospital, Basel, Switzerland, Ospedale Regionale di Lugano, Hôpital Fribourgeois
- Study start
- 8 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 Apr 2021 (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.
Convalescent plasma therapy has been recognized as safe and plasma transfusion is routinely used in clinical practice. A recent study showed that early administration of convalescent plasma can decrease the risk of complications in specific high-risk population.
The aim of the present study is to offer convalescent plasma therapy to immunocompromised patients and older adults in the early phase of a SARS-Cov-2 infection in order to accelerate viral clearance and prevent complication
Detailed description
This is an open-label non-controlled, non-randomised interventional study. Study population consist in immunocompromised patients and older adults with or without co-morbidities.
Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 or equivalent at maximum 3-7 days after diagnosis by RT-PCR or symptom onset or if having mild-moderate disease (WHO scale <4).
Patients will be followed-up up to 28 days to assess progression to WHO scale 4 disease, and 28-days mortality and viral load kinetics.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- open-label non-controlled, non-randomised interventional study
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Immunocompromised patients defined as
- Older adults defined as Age ≥ 75 years old or ≥ 65 years old with at least one co-existing condition
Key exclusion criteria (6 listed)
- Seroconversion at the time of inclusion
- Palliative care
- No signed informed consent
- History of previous transfusion-related Grade 3 adverse event according to Swissmedic definitions
- Disseminated intravascular coagulopathy (depending on specialist evaluation)
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 |
|---|---|---|
| SARS-CoV-2 convalescent plasmaIncluded patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 at maximum 3-7 days after diagnosis by RT-PCR or symptom onset. A second unit of plasma from a different donor can be proposed 24h after the first unit if immunocompromised and/or the patient received less than 3-5ml/kg of plasma volume. Additional units can be exceptionnally infused, at the investigator discretion. | Drug | – |
Primary outcome
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time frame: 7 days after plasma infusion
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement)
Time frame: 14 days after plasma infusion
Proportion of death
Time frame: 28 days after plasma infusion
2 secondary outcomes
Proportion of patients with cleared nasopharyngeal viral load
Time frame: 7 days after plasma infusion
Proportion of patients with cleared nasopharyngeal viral load
Time frame: 14 days after plasma infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
Laurent Kaiser, MD principal investigator
University Hospital, Geneva
Enos Bernasconi, MD principal investigator
Ospedale Regionale di Lugano
Véronique Erard, MD principal investigator
HFR-Fribourg Hôpital Cantonal
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SARS-CoV-2 convalescent plasma in people with Covid19 and Immuno-Deficiency, run by University Hospital, Geneva at 4 sites 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 26 inclusion and 6 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 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diem-Lan Vu Cantero, MD, PhD (+41795535512, diem-lan.vu@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patient that progress to WHO 8 ordinal scale ≥ 4 (oxygen requirement) (time frame: 7 days after plasma infusion). The study lists 3 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 8 Apr 2021.