Trial Outcomes & Findings for Convalescent Plasma Collection and Treatment in Pediatrics and Adults (NCT NCT04376034)
NCT ID: NCT04376034
Last Updated: 2026-05-29
Results Overview
Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma Measured in days for 365 days
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
117 participants
Primary outcome timeframe
365 days
Results posted on
2026-05-29
Participant Flow
Recipients were hospitalized patients who received convalescent plasma under protocol-defined eligibility criteria during the COVID-19 pandemic period.
This study enrolled plasma recipients only. No plasma donors were enrolled as study participants. West Virginia does not have a single entity with FDA registration/licensure and the required on-site equipment to collect convalescent plasma for transfusion. Although donor-related operational steps were included in the initial protocol, donor recruitment and collection were not performed. Stored convalescent plasma from external suppliers was used.
Participant milestones
| Measure |
Convalescent Plasma
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Overall Study
STARTED
|
117
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Convalescent Plasma
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Overall Study
Physician Decision
|
14
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Convalescent Plasma
n=117 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Age, Continuous
|
65 years
n=117 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=117 Participants
|
PRIMARY outcome
Timeframe: up to 30 daysTime from meeting protocol-specified infusion criteria to the start of convalescent plasma infusion, measured in days.
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Time of Meeting Infusion Criteria to Infusion
|
1 days
Interval 1.0 to 1.0
|
PRIMARY outcome
Timeframe: 30 days from dischargeNumber of participants who were alive 30 days after hospital discharge.
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient Survival
|
90 Participants
|
PRIMARY outcome
Timeframe: 365 daysPopulation: The plasma donor portion of the study was withdrawn due to the absence of any FDA-licensed collection center in West Virginia. No donor participants were enrolled.
Time it takes to identify eligible donors whom are willing to donate. Measured in days for 365 days
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 365 daysPopulation: The plasma donor portion of the study was withdrawn due to the absence of any FDA-licensed collection center in West Virginia. No donor participants were enrolled.
Time it takes the plasma collection center to contact willing donors whom are allowed to donate plasma Measured in days for 365 days
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: up to 1 yearPopulation: The plasma donor portion of the study was withdrawn due to the absence of any FDA-licensed collection center in West Virginia. No donor participants were enrolled.
Time until plasma is donated Measured every 24 hours up to 1 year
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearNumber of mortalities within those that enrolled in the study.
Outcome measures
| Measure |
Convalescent Plasma
n=117 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient Mortality
|
22 number of deaths
|
SECONDARY outcome
Timeframe: up to 1 yearLength of Stay in hospital. Measured every day until patient discharged from hospital up to 1 year
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient LOS
|
23.6 Days
Interval 3.0 to 122.0
|
SECONDARY outcome
Timeframe: Day 1Number of treatment-emergent adverse events recorded among recipients on this study day (Day 1) post infusion. \[Safety and Tolerability\]
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient AE (Day 1)
|
4 Events
|
SECONDARY outcome
Timeframe: Day 2Number of treatment-emergent adverse events recorded among recipients on this study day (Day 2) post infusion. \[Safety and Tolerability\]
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient AE (Day 2)
|
0 Events
|
SECONDARY outcome
Timeframe: Day 3Number of treatment-emergent adverse events recorded among recipients on this study day (Day 3) post infusion. \[Safety and Tolerability\]
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient AE (Day 3)
|
0 Events
|
SECONDARY outcome
Timeframe: Day 4Number of treatment-emergent adverse events recorded among recipients on this study day (Day 4) post infusion. \[Safety and Tolerability\]
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient AE (Day 4)
|
1 Events
|
SECONDARY outcome
Timeframe: Day 5Number of treatment-emergent adverse events recorded among recipients on this study day (Day 5) post infusion. \[Safety and Tolerability\]
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient AE (Day 5)
|
0 Events
|
SECONDARY outcome
Timeframe: Day 6Number of treatment-emergent adverse events recorded among recipients on this study day (Day 6) post infusion. \[Safety and Tolerability\]
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient AE (Day 6)
|
1 Events
|
SECONDARY outcome
Timeframe: Day 7Number of treatment-emergent adverse events recorded among recipients on this study day (Day 7) post infusion. \[Safety and Tolerability\]
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient AE (Day 7)
|
0 Events
|
SECONDARY outcome
Timeframe: Day 30Number of treatment-emergent adverse events recorded among recipients on this study day (Day 30) of follow up post infusion \[Safety and Tolerability\]
Outcome measures
| Measure |
Convalescent Plasma
n=102 Participants
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Plasma Recipient AE (Day 30)
|
0 Events
|
Adverse Events
Convalescent Plasma
Serious events: 16 serious events
Other events: 34 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Convalescent Plasma
n=117 participants at risk
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Blood and lymphatic system disorders
Transfusion-associated circulatory overload (TACO)
|
1.7%
2/117 • Number of events 2 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Extracorporeal Membrane Oxygenation (ECMO)
|
4.3%
5/117 • Number of events 5 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress requiring intubation
|
2.6%
3/117 • Number of events 3 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax requiring chest tube
|
3.4%
4/117 • Number of events 4 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
General disorders
Abdominal Compartment Syndrome
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
Other adverse events
| Measure |
Convalescent Plasma
n=117 participants at risk
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.
Convalescent Plasma: 1 to 2 units given over 4-6 hours. A unit will consist of about 200mL for both pediatric and adult populations.
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.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Transfusion related acute lung injury (TRALI)
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Transfusion-associated dyspnea (TAD)
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism (PE)
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Renal and urinary disorders
Acute kidney injury (AKI)
|
1.7%
2/117 • Number of events 2 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Abscess
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Healthcare-associated pneumonia (HCAP)
|
1.7%
2/117 • Number of events 2 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Gastrointestinal disorders
Stool Impaction
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration Pneumonia
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Intubated
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Blood and lymphatic system disorders
Bacteremia
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Blood and lymphatic system disorders
Sepsis
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress Low Flow Nasal Cannula (LFNC) to High Flow Nasal Cannula (HFNC)
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Psychiatric disorders
Anxiety
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Hepatobiliary disorders
pruritus
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Vascular Congestions
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral infiltrates
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress (BIPAP)
|
3.4%
4/117 • Number of events 4 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Addition of Nitric Oxide/Increase in Respiratory Distress
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Blood and lymphatic system disorders
Transfusion-associated circulatory overload (TACO)
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
2.6%
3/117 • Number of events 3 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Cardiac disorders
Hypertension
|
1.7%
2/117 • Number of events 2 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Cardiac disorders
Bradycardia
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
1.7%
2/117 • Number of events 2 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
|
Respiratory, thoracic and mediastinal disorders
Desaturation
|
0.85%
1/117 • Number of events 1 • 1 year after infusion
Investigators conducted monthly safety monitoring. The primary research team supervised data collection, and all adverse events were documented and reported in accordance with protocol requirements.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place