Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)NCT04389944
Amotosalen-Ultraviolet A Pathogen-Inactivated Convalescent Plasma in Addition to Best Supportive Care and Antiviral Therapy on Clinical Deterioration in Adults Presenting With Moderate to Severe COVID-19
A study testing convalescent plasma application to SARS-CoV-2 infected patients in people with Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)
- What is being tested?
- convalescent plasma application to SARS-CoV-2 infected patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Mar 2020to 30 Jun 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male patients who have been tested positive for SARS-CoV2 at University Hospital Basel, Switzerland or in the near surroundings more than 10 days before enrolment
- 18-60 years of age
- asymptomatic (thus successfully overcome COVID-19) >14 days back
- two consecutive naso-pharyngeal swabs tested negative for quantitative PCR-test for SARS-CoV-2 prior to plasma donation to demonstrate infection Resolution, or more than 28 days asymptomatic after SARS-CoV2 infection
- Body weight of at least 50 kg
- donor eligibility criteria according to the Swiss Red Cross Blood Transfusion Service as for regular blood donation
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- SARS-CoV-2 infection confirmed by PCR in respiratory secretions (naso- pharyngeal swab, broncho-alveolar lavage, sputum)
- hospitalized
- pulmonary infiltrates compatible with COVID-19 on CT-scan
- availability of blood group compatible convalescent plasma
- signed informed consent
Who cannot join
- Female donors are excluded from plasma donation
- Treatment with Actemra® (Tocilizumab) in the course of COVID-19
- Current hospitalization
- Current or previous relevant medical conditions that pose a risk for the donor
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Blutspendezentrum SRK beider Basel, University Hospital Basel
Basel, 4031
About this study
Official title: Amotosalen-Ultraviolet A Pathogen-Inactivated Convalescent Plasma in Addition to Best Supportive Care and Antiviral Therapy on Clinical Deterioration in Adults Presenting With Moderate to Severe Coronavirus Disease 2019 Infectious Disease (COVID-19)
This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.
- Being tested
- convalescent plasma application to SARS-CoV-2 infected patients
- Keywords
- convalescent plasma, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- 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 plasma application to SARS-CoV-2 infected patientsOther
In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma as follows: 200ml at enrolment and 200ml at 12-24 hours follow-up.
| Study group | Role | What they receive |
|---|---|---|
| convalescent plasma treatment | Experimental | After confirmation of negative SARS-CoV-2 polymerase chain reaction (PCR) in two consecutive nasal swabs or 28 days after resolution of symptoms, donor check is performed and plasma donation occurs by apheresis. The plasma is photochemically pathogen reduced using the INTERCEPT Blood System.
In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma as follows: 200ml at enrolment and 200ml at 12-24 hours follow-up. Receives: Other: convalescent plasma application to SARS-CoV-2 infected patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events in convalescent plasma treated patients
Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection
Measured: From baseline (enrolment) to 24 hours follow-up
Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients
Change in SARS-CoV2 quantitative in nasopharyngeal swab
Measured: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Transfer to ICU
Transfer to ICU
Measured: at Baseline (admission to Covid-ward) until day 28
in-hospital death
in-hospital death
Measured: at Baseline (admission to Covid-ward) until day 28
Virologic clearance in plasma of convalescent plasma treated patients
Change in SARS-CoV2 quantitative in plasma
Measured: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Secondary outcomes (2)
Time to discharge from hospital after enrolment
Duration of hospitalisation
Measured: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)
Humoral immune response
Rise of SARS-CoV-2 antibody titers (on day 1, 7, 14 and 28)
Measured: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start31 Mar 2020
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Buser, Prof. Dr. med., Principal investigator, Blutspendezentrum SRK beider Basel, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389944
- Sponsor's protocol ID
- Req-2020-00508; me20khanna2
- Status last verified
- Aug 2020
- First submitted
- 12 May 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amotosalen-Ultraviolet A Pathogen-Inactivated Convalescent Plasma in Addition to Best Supportive Care and Antiviral Therapy on Clinical Deterioration in Adults Presenting With Moderate to Severe Coronavirus Disease 2019 Infectious Disease (COVID-19)
- ClinicalTrials.gov ID
- NCT04389944
- Acronym / sponsor ID
- Req-2020-00508; me20khanna2
- Keywords
- convalescent plasma, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 31 Mar 2020 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 15 May 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.
This project investigates individual treatments using convalescent severe acute respiratory Syndrome Coronavirus 2 (SARS-CoV-2) plasma in SARS-CoV-2 infected patients at risk for disease progression. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma. Only patients with moderate to severe disease at risk for transfer to intensive care unit or patients at the intensive care unit with limited treatment options will be treated.
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 treatment | Experimental | Other: convalescent plasma application to SARS-CoV-2 infected patientsAfter confirmation of negative SARS-CoV-2 polymerase chain reaction (PCR) in two consecutive nasal swabs or 28 days after resolution of symptoms, donor check is performed and plasma donation occurs by apheresis. The plasma is photochemically pathogen reduced using the INTERCEPT Blood System. In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma as follows: 200ml at enrolment and 200ml at 12-24 hours follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- male patients who have been tested positive for SARS-CoV2 at University Hospital Basel, Switzerland or in the near surroundings more than 10 days before enrolment
- 18-60 years of age
- asymptomatic (thus successfully overcome COVID-19) >14 days back
- two consecutive naso-pharyngeal swabs tested negative for quantitative PCR-test for SARS-CoV-2 prior to plasma donation to demonstrate infection Resolution, or more than 28 days asymptomatic after SARS-CoV2 infection
- Body weight of at least 50 kg
Key exclusion criteria (4 listed)
- Female donors are excluded from plasma donation
- Treatment with Actemra® (Tocilizumab) in the course of COVID-19
- Current hospitalization
- Current or previous relevant medical conditions that pose a risk for the donor
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 plasma application to SARS-CoV-2 infected patientsIn addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma as follows: 200ml at enrolment and 200ml at 12-24 hours follow-up. | Other | convalescent plasma treatment |
Primary outcome
Serious adverse events in convalescent plasma treated patients
Time frame: From baseline (enrolment) to 24 hours follow-up
Serious adverse events during the study period include transfusion reaction (fever, rash), transfusion related acute lung injury (TRAU) , transfusion associated circulatory overload (TACO) , transfusion related infection
Virologic clearance in nasopharyngeal swab of convalescent plasma treated patients
Time frame: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Change in SARS-CoV2 quantitative in nasopharyngeal swab
Transfer to ICU
Time frame: at Baseline (admission to Covid-ward) until day 28
Transfer to ICU
in-hospital death
Time frame: at Baseline (admission to Covid-ward) until day 28
in-hospital death
Virologic clearance in plasma of convalescent plasma treated patients
Time frame: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, day 28
Change in SARS-CoV2 quantitative in plasma
2 secondary outcomes
Time to discharge from hospital after enrolment
Time frame: at Baseline (admission to Covid-ward) until discharge (approx. 28 days)
Humoral immune response
Time frame: at Baseline (admission to Covid-ward), day -1 (before plasma), day 1 (after plasma), day7, day 14, 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 4 Aug 2020.
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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.
Andreas Buser, Prof. Dr. med. principal investigator
Blutspendezentrum SRK beider Basel, Universitätsspital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing convalescent plasma application to SARS-CoV-2 infected patients in people with Coronavirus Disease 2019 Infectious Disease (COVID-19 Infection), run by University Hospital, Basel, Switzerland 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 11 inclusion and 4 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 4 Aug 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 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?
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?
Serious adverse events in convalescent plasma treated patients (time frame: From baseline (enrolment) to 24 hours follow-up). The study lists 5 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 4 Aug 2020.