Convalescent Plasma for Treatment of COVID-19: An Exploratory Dose Identifying Study
NCT ID: NCT04384497
Last Updated: 2021-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
10 participants
INTERVENTIONAL
2020-05-07
2020-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Convalescent plasma treatment
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.
SARS-CoV-2 convalescent plasma
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.
Interventions
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SARS-CoV-2 convalescent plasma
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Danderyd Hospital
OTHER
Karolinska University Hospital
OTHER
Karolinska Institutet
OTHER
Joakim Dillner
OTHER
Responsible Party
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Joakim Dillner
Professor of Infectious Disease Epidemiology; Director of R&D
Principal Investigators
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Johan Ursing, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Danderyd Hospital
Locations
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Danderyd Hospital
Danderyd, Stockholm County, Sweden
Karolinska University Hospital
Stockholm, , Sweden
Countries
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Other Identifiers
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CP2
Identifier Type: -
Identifier Source: org_study_id