COVIDNCT04445207
Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
A study testing Convalescent Plasma in people with COVID and Sars-CoV2, run by Jonathan Gerber at 1 site in United States.
Trial summary
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- COVID, Sars-CoV2, Corona Virus Infection
- What is being tested?
- Convalescent Plasma
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- At least 12 years of age
- Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
- Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
- Severe COVID-19 is defined by one or more of the following:
- Dyspnea
- Respiratory frequency ≥ 30/min
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- Blood oxygen saturation ≤ 93%
- Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
- Lung infiltrates > 50% within 24-48 hours
- Life-threatening COVID-19 is defined as one or more of the following:
- Respiratory failure
- Septic shock
- Multiple organ dysfunction or failure
Who cannot join
- History of prior life-threatening reactions to transfusion of blood products
- Not receiving other therapies that would preclude plasma transfusion
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School
Worcester, Massachusetts, 01655
About this study
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
Read the detailed description
As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.
- Conditions
- COVID, Sars-CoV2, Corona Virus Infection
- Being tested
- Convalescent Plasma
- Keywords
- COVID-19, Coronavirus, Sars-CoV2
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaBiological
One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Jonathan Gerber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Gerber, University of Massachusetts, Worcester
- Investigators
- Jonathan Gerber, MD, Principal investigator, UMASS MEDICAL SCHOOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445207
- Sponsor's protocol ID
- H000020420
- Status last verified
- May 2023
- First submitted
- 20 Jun 2020
- Last updated
- 25 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Expanded Access Treatment With Convalescent Plasma for the Treatment of Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04445207
- Acronym / sponsor ID
- H000020420
- Conditions
- COVID, Sars-CoV2, Corona Virus Infection
- Keywords
- COVID-19, Coronavirus, Sars-CoV2
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Jonathan GerberUniversity, hospital or other
- First posted
- 24 Jun 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.
The purpose of this program is to see if giving convalescent plasma to individuals who test positive for COVID-19 may reduce their symptoms and help minimize complications from the illness.
Detailed description
As individuals are exposed to pathogens, the body's immune system works to create antibodies toward those pathogens. These antibodies can be found in the plasma portion of the blood. This plasma is referred to as "Convalescent plasma" and contains these infection fighting antibodies. Through a blood donation, this convalescent plasma is collected from a recovered person and transfused to a sick patient who is still fighting the same virus. This protocol will make convalescent COVID-19 plasma available to individuals who meet the eligibility criteria described.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- At least 12 years of age
- Covid-19 Convalescent Plasma (CCP) treatment is in line with the patient's current goals of care (i.e. recipient cannot be DNI status)
- Laboratory confirmed diagnosis of infection with SARS-CoV-2 that is severe or life threatening OR the individual is judged by the treating provider to be at a high risk of progression to severe or life-threatening disease.
- Severe COVID-19 is defined by one or more of the following:
- Life-threatening COVID-19 is defined as one or more of the following:
Key exclusion criteria (2 listed)
- History of prior life-threatening reactions to transfusion of blood products
- Not receiving other therapies that would preclude plasma transfusion
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 PlasmaOne to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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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.
Jonathan Gerber, MD principal investigator
UMASS MEDICAL SCHOOL
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 in people with COVID and Sars-CoV2, run by Jonathan Gerber at 1 site in United States.
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 13 inclusion and 2 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 25 May 2023. 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 United States. 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?
Results are not available in the source record.
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.
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 25 May 2023.