COVID-19Phase 1/2NCT04384497
Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study
A Phase 1/2 study testing SARS-CoV-2 convalescent plasma in people with COVID-19, run by Joakim Dillner at 2 sites in Sweden.
Trial summary
Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients. 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?
- SARS-CoV-2 convalescent plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesSweden
- Study dates
- 7 May 2020to 1 Dec 2020
- Phase
- Phase 1/2
- 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
- Age 18 or older
- Admitted to a study hospital
- Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
- Written informed consent after meeting with a study physician and ability and willingness to complete follow up
Who cannot join
- No matching plasma donor (Exact matching in both the ABO system is required)
- Unavailability of plasma
- Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- Estimated glomerular filtration rate <60 (kidney failure stage III or more)
- Pregnancy (urinary-hcg)
- Breast feeding
- History of severe allergic reactions to foods or other substances that the donor may have been exposed to (for example severe peanut allergy)
- Inability to give informed consent
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Danderyd Hospital
Danderyd, Stockholm County, 18257
Karolinska University Hospital
Stockholm, 14186
About this study
Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients.
In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.
- Conditions
- COVID-19
- Being tested
- SARS-CoV-2 convalescent plasma
- Keywords
- COVID-19 convalescent plasma treatment, SARS-CoV-2 infection, Dosing, Safety, Effectiveness
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 convalescent plasmaBiological
Treatment with convalescent plasma (200ml, up to a maximum of 7 CP infusions). Plasma from consenting individuals who have recovered from SARS-CoV-2 infection.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent plasma treatment | Experimental | Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 7 CP infusions. CP will be given as a slow infusion over 1 hour. Patients will be monitored for adverse events, especially allergic reactions. Receives: Biological: SARS-CoV-2 convalescent plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy
Progression to non-invasive or invasive ventilation or a sustained requirement of 15L of supplementary oxygen therapy in patients that are not eligible for intensive care treatment.
Measured: Measured in the first 28 days after inclusion.
Secondary outcomes (6)
Adverse events
Adverse reactions and serious adverse reactions. The safety of the intervention will be assessed with regard to AEs, baseline medical conditions, and findings from the physical examination and laboratory tests. Possible adverse events will be elicited using a modification and Swedish translation (appendix 6) of Common Terminology Criteria for Adverse Events v5.0 and they will be continuously reported to the sponsor. Adverse events related to convalescent plasma therapy shall be followed to assess reversibility.
Measured: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.
Dose of plasma needed to clear viremia
Measured as doses of convalescent plasma administered (1-7 infusions, 200ml).
Measured: 28 days
Clearance of viremia
SARS-CoV-2 RNA detection by PCR in blood or serum. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measured: 6 months.
Fever and symptoms
Time to resolution of fever and symptoms. Breathing rate, peripheral oxygen saturation (measured with pulse oximetry after 20 minutes of rest), oxygen use, pulse, blood pressure, body temperature and mental state will be monitored 3 times/day while hospitalized.
Measured: Until discharged from the hospital, up to 2 months
Inflammatory parameters
Time to normalization of inflammatory parameters. Blood samples for inflammatory parameters will be taken daily until normalized or discharged from the hospital.
Measured: Until discharged from the hospital, up to 2 months
Antibody response to SARS-CoV-2
Characterization of the antibody response to SARS-CoV-2. Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start7 May 2020
- Primary completion1 Jun 2020
- Study completion1 Dec 2020
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open, non-randomised controlled, safety and dose identifying clinical trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joakim Dillner
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, Karolinska University Hospital, Karolinska Institutet
- Responsible party
- Sponsor-investigator, Joakim Dillner, Karolinska University Hospital
- Investigators
- Johan Ursing, MD, PhD, Principal investigator, Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384497
- Sponsor's protocol ID
- CP2
- Status last verified
- Dec 2021
- First submitted
- 7 May 2020
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will be sharing the data, but the management plan is being designed.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study
- ClinicalTrials.gov ID
- NCT04384497
- Acronym / sponsor ID
- CP2
- Conditions
- COVID-19
- Keywords
- COVID-19 convalescent plasma treatment, SARS-CoV-2 infection, Dosing, Safety, Effectiveness
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Joakim DillnerUniversity, hospital or other
- Collaborators
- Danderyd Hospital, Karolinska University Hospital, Karolinska Institutet
- Study start
- 7 May 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 12 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.
Convalescent plasma has been shown to be safe and effective for treatment of several diseases. Preliminary data indicates that it is safe and effective for treatment of COVID. However, data is limited to small studies and case series on severely ill patients.
In a preliminary safety study 10 patients with severe COVID-19, defined as requiring supplementary oxygen, having fever and a duration of illness less than 11 days were treated with 200 ml of CP. CP was given as a slow infusion without obvious adverse events. Eight patients had viremia. One patient rapidly cleared the virus and recovered following CP treatment. CP infusion did not appear to clear viremia in 7/8 patients. Five of these were eventually admitted to ICU. Thus CP did not appear to cause acute toxicity but did not seem to be effective at the dose used. Viremia seemed to be a marker of a high risk of disease progression The proposed study thus aims to treat a high risk population identified by having viremia irrespective of but hopefully before they develop pulmonary injury such that they require supplementary oxygen therapy. Moreover the dose of plasma will be increased incrementally with the aim of clearing viremia as our initial study indicates that continued viremia is driving COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open, non-randomised controlled, safety and dose identifying clinical trial
| Arm | Type | Receives |
|---|---|---|
| Convalescent plasma treatment | Experimental | Biological: SARS-CoV-2 convalescent plasmaParticipants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 7 CP infusions. CP will be given as a slow infusion over 1 hour. Patients will be monitored for adverse events, especially allergic reactions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or older
- Admitted to a study hospital
- Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- Negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential
- Written informed consent after meeting with a study physician and ability and willingness to complete follow up
Key exclusion criteria (8 listed)
- No matching plasma donor (Exact matching in both the ABO system is required)
- Unavailability of plasma
- Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- Estimated glomerular filtration rate <60 (kidney failure stage III or more)
- Pregnancy (urinary-hcg)
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 plasmaTreatment with convalescent plasma (200ml, up to a maximum of 7 CP infusions). Plasma from consenting individuals who have recovered from SARS-CoV-2 infection. | Biological | Convalescent plasma treatment |
Primary outcome
Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy
Time frame: Measured in the first 28 days after inclusion.
Progression to non-invasive or invasive ventilation or a sustained requirement of 15L of supplementary oxygen therapy in patients that are not eligible for intensive care treatment.
6 secondary outcomes
Adverse events
Time frame: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.
Dose of plasma needed to clear viremia
Time frame: 28 days
Clearance of viremia
Time frame: 6 months.
Fever and symptoms
Time frame: Until discharged from the hospital, up to 2 months
Inflammatory parameters
Time frame: Until discharged from the hospital, up to 2 months
Antibody response to SARS-CoV-2
Time frame: 6 months
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 3 Dec 2021.
- Individual participant dataSharing planned: Yes. The investigators will be sharing the data, but the management plan is being designed.
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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.
Johan Ursing, MD, PhD principal investigator
Danderyd Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SARS-CoV-2 convalescent plasma in people with COVID-19, run by Joakim Dillner at 2 sites in Sweden.
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 5 inclusion and 8 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number and proportion of patients with progression to ventilation or sustained requirement of supplementary oxygen therapy (time frame: Measured in the first 28 days after inclusion.). 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 3 Dec 2021.