- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04390178
Convalescent Plasma as Treatment for Acute Coronavirus Disease (COVID-19)
December 1, 2021 updated by: Joakim Dillner
Plasma From Individuals Who Have Recovered From Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection as Treatment for Acute COVID-19 Disease
There is currently no effective treatment for COVID-19 except best supportive care.
The aim is assess the safety, tolerability and efficacy of convalescent plasma for treatment of patients with varying degrees of COVID-19 illness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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-19.
However, data is limited to small studies and case series on severely ill patients.
The proposed study assesses the safety and efficacy earlier in the course of illness, in slightly less severe patients with the possibility of detecting less severe adverse events and the potential for early treatment to hinder the development of severe disease.
Plasma is collected from consenting donors who have recovered from SARS-CoV-2.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Danderyd, Sweden, 182 57
- Danderyd Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 and <81 years
- Active COVID-19 defined as symptoms + SARS CoV-2 identified from upper or lower airway samples
- Fever ≥38.5C, admitted to a study hospital, hypoxemia defined as having a peripheral oxygen saturation below 93% (measured by pulse oximetry) and a breathing rate of >20 breaths per minute without supplemental oxygen treatment
- A 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:
- No matching plasma donor (exact matching in both the ABO system and the Rh system is required)
- Unavailability of plasma
- Significant growth of alternative lower airway pathogen such as Streptococcus pneumoniae or Haemophilus influenzae in sputum
- Disease duration >8 Days
- Estimated glomerular filtration rate <60 (kidney failure stage III or more)
- Pregnancy (urinary-hcg), breast feeding,
- History of severe allergic reactions
- Inability to give informed consent
Significantly compromised immunity.*
- Compromised immunity includes but is not limited to treatment with major immunosuppressive agents including high dose corticosteroids, anti-tumor necrosis factor (TNF) agents, calcineurin inhibitors, mTOR inhibitors, lymphocyte depleting biological agents, chemotherapeutic anti neoplastic agents. Also patients with advanced HIV/AIDS, severe immunodeficiency such as hypoglobulinemia, decompensated liver cirrhosis and bone marrow transplant the last year will be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Convalescent plasma treatment
All participants will receive a bag of convalescent plasma.
The bag volume will be 180-200 ml.
The first 10 patients will receive 1, 5, 10, 50 and 134 ml of plasma at 30 minute intervals while being closely monitored for adverse events, especially allergic reactions.
The remaining twenty patients will receive the convalescent plasma as a slow infusion according to normal routines.
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Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease progression
Time Frame: 28 days
|
Decrease in progression to requiring non-invasive or invasive ventilation
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28 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events (AE)
Time Frame: The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.
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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.
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The reporting period for AEs starts at inclusion and ends at the final follow-up visit 2 months after inclusion.
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Time ro resolution of fever and symptoms
Time Frame: Until discharged from the hospital, up to 2 months
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Measured daily until discharged from the hospital.
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Until discharged from the hospital, up to 2 months
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Clearance of viraemia
Time Frame: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.
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SARS-CoV-2 RNA detection by polymerase chain reaction (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.
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Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.
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Inflammatory parameter C-reactive protein (CRP)
Time Frame: Until discharged from the hospital, up to 2 months
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Time to normalization of inflammatory parameter C-reactive protein (CRP).
Blood sample for this marker will be taken daily until normalized or discharged from hospital.
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Until discharged from the hospital, up to 2 months
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Inflammatory parameter white blood cell count
Time Frame: Until discharged from the hospital, up to 2 months
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Time to normalization of inflammatory parameter white blood cell count (WBC).
Blood sample for this marker will be taken daily until normalized or discharged from hospital.
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Until discharged from the hospital, up to 2 months
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Inflammatory parameter haemoglobin (Hb)
Time Frame: Until discharged from the hospital, up to 2 months
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Time to normalization of inflammatory parameter haemoglobin (Hb).
Blood sample for this marker will be taken daily until normalized or discharged from hospital.
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Until discharged from the hospital, up to 2 months
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Inflammatory parameter Pro-calcitonin
Time Frame: Until discharged from the hospital, up to 2 months
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Time to normalization of inflammatory parameter Pro-calcitonin.
Blood sample for this marker will be taken daily until normalized or discharged from hospital.
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Until discharged from the hospital, up to 2 months
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Inflammatory parameter Creatine Kinase
Time Frame: Until discharged from the hospital, up to 2 months
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Time to normalization of inflammatory parameter Creatine Kinase.
Blood sample for this marker will be taken daily until normalized or discharged from hospital.
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Until discharged from the hospital, up to 2 months
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Antibody response to SARS-CoV-2
Time Frame: Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.
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Change in the antibody response to SARS-CoV-2 as measured in serum.
Blood samples for immunological analyses and serology will be taken daily until discharge, on day 28, and at 6 months.
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Evaluated daily until discharge, at day 28, and last measurement taken at 6 months of follow-up after inclusion.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Johan Ursing, MD, PhD, Danderyd Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 10, 2020
Primary Completion (ACTUAL)
June 30, 2020
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
April 10, 2020
First Submitted That Met QC Criteria
May 13, 2020
First Posted (ACTUAL)
May 15, 2020
Study Record Updates
Last Update Posted (ACTUAL)
December 16, 2021
Last Update Submitted That Met QC Criteria
December 1, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
We will be sharing data but data the management plan is being designed.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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