COVID19Phase 3NCT04376034
Convalescent Plasma Collection and Treatment in Pediatrics and Adults
A Phase 3 study testing Convalescent Plasma in people with COVID19 and Coronavirus Infection, run by West Virginia University at 1 site in United States.
Trial summary
This is a prospective study, using plasma to help fight off infections of those suffering from COVID-19 in accordance with collection guidelines for plasma and FDA IND requirements. This study included up to 240 participants potentially receiving convalescent plasma. Read more about this study
- Who is it for?
- Ages 31 days and older
- Conditions the study is for
- COVID19, Coronavirus Infection, Coronavirus
- What is being tested?
- Convalescent Plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2020to 21 Apr 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 31 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Plasma donation:
- Individuals that do not meet the requirement from the American Red Cross for plasma donation or equivalent
- Individuals plasma that has not passed safety screening after procurement by the American Red Cross for plasma donation or equivalent
- Plasma Recipients
- Individuals with COVID19 who are not in clinical concern for rapid progression, severe or critical condition
- Individuals who are in critical condition that are not confirmed to have COVID19
- Individuals with known Selective IgA Deficiency, that has not been found to be absent of anti-IgA antibodies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma
This is a prospective study, using plasma to help fight off infections of those suffering from COVID-19 in accordance with collection guidelines for plasma and FDA IND requirements. This study included up to 240 participants potentially receiving convalescent plasma.
NOTE: West Virginia does not have any entity with the required FDA registration/licensure or necessary equipment to collect convalescent plasma for transfusion. Therefore, the plasma donation portion of this study was not completed.
Read the detailed description
Convalescent plasma (here on referred to as plasma) has been used in emergency life-threatening situations to treat infections for over 100 years. The plasma is donated by an individual that has recovered from the very same infection that another person is infected with. This plasma is enriched in the antibodies that recognize and helped the body's immune system fight off the infection. When transfused from donor to recipient those antibodies will aid the recipient in fighting off the infection. In recent history this has been used to fight Ebola. Recently, the Federal Food and Drug Agency (FDA) made possible expedited Investigational New Drug (IND) process for plasma use in the fight against COVID19 for emergency and lifesaving uses.
There are several other investigational drugs for treatment of COVID19 such as: Remdesivir, an antiviral. The off-label use of hydroxychloroquine, Lopinavir/ritonavir, or Tocilizumab have been authorized. Convalescent plasma mechanism of action helps to promote health by working with one's own immune system and will not interfere with the other proposed medications. It also will not weaken the immune system as the investigational and off label medications have the potential to do. Convalescent plasma is time honored and although investigational for each use against novel or rare infections, it is the basis for IgG infusions in the immunodeficient populations. Currently the use of IgG infusions such as Intravenous IgG (IVIG) is assumed to not have the right antibodies from donors in the general public. This is secondary to the novel nature of the COVID19 and the fact that the IVIG available today was collected 6 to 12 months ago from plasma donors; prior to the COVID19's outbreak discovery in China.
It is for that reason that IVIG is not recommended at this time and the FDA has made special fast-tracking announcements for plasma use for COVID19. Currently, plasma is the only treatment that has a previous history of success in these novel or rare viral outbreak situations. It has already been reported to have been associated with survival of 5 out of 5 participants in a pilot study in China
For the purpose of this study advanced respiratory support will include any measure of respiratory support above low flow nasal cannula oxygen (2 Liters/minute flow rate).
For the purpose of this study dyspnea will be defined as any shortness of breath that is not completely relieved with the use of low flow nasal canula oxygen set to 2 Liters/minute flow rate and/or requiring breathing treatments such as but not limited to: bronchodilators more than every 4 hours to relieve symptoms.
In the event that more than one recipient is identified and plasma is available in less than the total number of approved recipients, priority will be given to those approved by the FDA for the IND use of plasma for severe or critical condition. If there still exists a deficit of plasma, the priority will be given to those on advanced respiratory support with the most critical settings (if unclear then will be considered a tie); active pressor treatments; age <1 years of age with days of life, age adjusted for prematurity as a tie breaker; age >60 with years as a tie breaker; and lastly lottery pull with potential remaining recipients as the final tie breaker.
- Being tested
- Convalescent Plasma
- Keywords
- Covid19, Covid 19, Convalescent Plasma, SARS-CoV-2, Pediatric, Pediatrics
- Medical subject headings
- COVID-19, Coronavirus Infections, Virus Diseases, RNA Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Convalescent PlasmaBiological
1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations. An additional unit of plasma will be given every 3 days up to 8 units if patient was not improving or getting worse.
All pediatric patients will receive 10 mL/kg (1 dose) if moderate with concern for rapid progression up to 1 Unit; 10 mL/kg up to 2 units if severe or critical.
| Study group | Role | What they receive |
|---|---|---|
| Convalescent Plasma | Experimental | Convalescent Plasma containing SARS-CoV-2 antibodies will be given to eligible recipients within the hospital setting that fit eligibility requirements, the recipient's condition, and the availability of the plasma. Receives: Biological: Convalescent Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Meeting Infusion Criteria to Infusion
Time from meeting protocol-specified infusion criteria to the start of convalescent plasma infusion, measured in days.
Measured: up to 30 days
Plasma Recipient Survival
Number of participants who were alive 30 days after hospital discharge.
Measured: 30 days from discharge
Identify Plasma Donor
Time it takes to identify eligible donors whom are willing to donate. Measured in days for 365 days
Measured: 365 days
Outreach to Plasma Donor
Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma Measured in days for 365 days
Measured: 365 days
Plasma Donor Time Until Donated
Time until plasma is donated Measured every 24 hours up to 1 year
Measured: up to 1 year
Secondary outcomes (10)
Plasma Recipient Mortality
Number of mortalities within those that enrolled in the study.
Measured: Up to 1 year
Plasma Recipient LOS
Length of Stay in hospital. Measured every day until patient discharged from hospital up to 1 year
Measured: up to 1 year
Plasma Recipient AE (Day 1)
Number of treatment-emergent adverse events recorded among recipients on this study day (Day 1) post infusion. [Safety and Tolerability]
Measured: Day 1
Plasma Recipient AE (Day 2)
Number of treatment-emergent adverse events recorded among recipients on this study day (Day 2) post infusion. [Safety and Tolerability]
Measured: Day 2
Plasma Recipient AE (Day 3)
Number of treatment-emergent adverse events recorded among recipients on this study day (Day 3) post infusion. [Safety and Tolerability]
Measured: Day 3
Plasma Recipient AE (Day 4)
Number of treatment-emergent adverse events recorded among recipients on this study day (Day 4) post infusion. [Safety and Tolerability]
Measured: Day 4
Plasma Recipient AE (Day 5)
Number of treatment-emergent adverse events recorded among recipients on this study day (Day 5) post infusion. [Safety and Tolerability]
Measured: Day 5
Plasma Recipient AE (Day 6)
Number of treatment-emergent adverse events recorded among recipients on this study day (Day 6) post infusion. [Safety and Tolerability]
Measured: Day 6
Plasma Recipient AE (Day 7)
Number of treatment-emergent adverse events recorded among recipients on this study day (Day 7) post infusion. [Safety and Tolerability]
Measured: Day 7
Plasma Recipient AE (Day 30)
Number of treatment-emergent adverse events recorded among recipients on this study day (Day 30) of follow up post infusion [Safety and Tolerability]
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start16 Apr 2020
- Primary completion28 Feb 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Peppers, West Virginia University
- Investigators
- Brian Peppers, DO, PhD, Principal investigator, WVU Medicine Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376034
- Sponsor's protocol ID
- 2004965705
- Status last verified
- May 2026
- First submitted
- 19 Apr 2020
- Last updated
- 29 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convalescent Plasma Collection From Individuals That Recovered From COVID19 and Treatment of Critically Ill Individuals With Donor Convalescent Plasma
- ClinicalTrials.gov ID
- NCT04376034
- Acronym / sponsor ID
- 2004965705
- Keywords
- Covid19, Covid 19, Convalescent Plasma, SARS-CoV-2, Pediatric, Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Posted 29 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective study, using plasma to help fight off infections of those suffering from COVID-19 in accordance with collection guidelines for plasma and FDA IND requirements. This study included up to 240 participants potentially receiving convalescent plasma.
NOTE: West Virginia does not have any entity with the required FDA registration/licensure or necessary equipment to collect convalescent plasma for transfusion. Therefore, the plasma donation portion of this study was not completed.
Detailed description
Convalescent plasma (here on referred to as plasma) has been used in emergency life-threatening situations to treat infections for over 100 years. The plasma is donated by an individual that has recovered from the very same infection that another person is infected with. This plasma is enriched in the antibodies that recognize and helped the body's immune system fight off the infection. When transfused from donor to recipient those antibodies will aid the recipient in fighting off the infection. In recent history this has been used to fight Ebola. Recently, the Federal Food and Drug Agency (FDA) made possible expedited Investigational New Drug (IND) process for plasma use in the fight against COVID19 for emergency and lifesaving uses.
There are several other investigational drugs for treatment of COVID19 such as: Remdesivir, an antiviral. The off-label use of hydroxychloroquine, Lopinavir/ritonavir, or Tocilizumab have been authorized. Convalescent plasma mechanism of action helps to promote health by working with one's own immune system and will not interfere with the other proposed medications. It also will not weaken the immune system as the investigational and off label medications have the potential to do. Convalescent plasma is time honored and although investigational for each use against novel or rare infections, it is the basis for IgG infusions in the immunodeficient populations. Currently the use of IgG infusions such as Intravenous IgG (IVIG) is assumed to not have the right antibodies from donors in the general public. This is secondary to the novel nature of the COVID19 and the fact that the IVIG available today was collected 6 to 12 months ago from plasma donors; prior to the COVID19's outbreak discovery in China.
It is for that reason that IVIG is not recommended at this time and the FDA has made special fast-tracking announcements for plasma use for COVID19. Currently, plasma is the only treatment that has a previous history of success in these novel or rare viral outbreak situations. It has already been reported to have been associated with survival of 5 out of 5 participants in a pilot study in China
For the purpose of this study advanced respiratory support will include any measure of respiratory support above low flow nasal cannula oxygen (2 Liters/minute flow rate).
For the purpose of this study dyspnea will be defined as any shortness of breath that is not completely relieved with the use of low flow nasal canula oxygen set to 2 Liters/minute flow rate and/or requiring breathing treatments such as but not limited to: bronchodilators more than every 4 hours to relieve symptoms.
In the event that more than one recipient is identified and plasma is available in less than the total number of approved recipients, priority will be given to those approved by the FDA for the IND use of plasma for severe or critical condition. If there still exists a deficit of plasma, the priority will be given to those on advanced respiratory support with the most critical settings (if unclear then will be considered a tie); active pressor treatments; age <1 years of age with days of life, age adjusted for prematurity as a tie breaker; age >60 with years as a tie breaker; and lastly lottery pull with potential remaining recipients as the final tie breaker.
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 | Experimental | Biological: Convalescent PlasmaConvalescent Plasma containing SARS-CoV-2 antibodies will be given to eligible recipients within the hospital setting that fit eligibility requirements, the recipient's condition, and the availability of the plasma. |
Who may qualify
- Ages
- 31 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Plasma donation:
- Plasma Recipients
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 Plasma1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations. An additional unit of plasma will be given every 3 days up to 8 units if patient was not improving or getting worse. All pediatric patients will receive 10 mL/kg (1 dose) if moderate with concern for rapid progression up to 1 Unit; 10 mL/kg up to 2 units if severe or critical. | Biological | Convalescent Plasma |
Primary outcome
Time of Meeting Infusion Criteria to Infusion
Time frame: up to 30 days
Time from meeting protocol-specified infusion criteria to the start of convalescent plasma infusion, measured in days.
Plasma Recipient Survival
Time frame: 30 days from discharge
Number of participants who were alive 30 days after hospital discharge.
Identify Plasma Donor
Time frame: 365 days
Time it takes to identify eligible donors whom are willing to donate. Measured in days for 365 days
Outreach to Plasma Donor
Time frame: 365 days
Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma Measured in days for 365 days
Plasma Donor Time Until Donated
Time frame: up to 1 year
Time until plasma is donated Measured every 24 hours up to 1 year
10 secondary outcomes
Plasma Recipient Mortality
Time frame: Up to 1 year
Plasma Recipient LOS
Time frame: up to 1 year
Plasma Recipient AE (Day 1)
Time frame: Day 1
Plasma Recipient AE (Day 2)
Time frame: Day 2
Plasma Recipient AE (Day 3)
Time frame: Day 3
Plasma Recipient AE (Day 4)
Time frame: Day 4
Plasma Recipient AE (Day 5)
Time frame: Day 5
Plasma Recipient AE (Day 6)
Time frame: Day 6
Plasma Recipient AE (Day 7)
Time frame: Day 7
Plasma Recipient AE (Day 30)
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for COVID19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
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.
Brian Peppers, DO, PhD principal investigator
WVU Medicine Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Convalescent Plasma in people with COVID19 and Coronavirus Infection, run by West Virginia University 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 0 inclusion and 7 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 29 May 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time of Meeting Infusion Criteria to Infusion (time frame: up to 30 days). 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 29 May 2026.