Trial Outcomes & Findings for Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients (NCT NCT04524507)

Last Updated: 2021-12-03

Results Overview

Total number of SAE among all participants through Day 14; Definition of SAE per protocol and will only be included if related to COVID-19 Convalescent Plasma (CCP): 1. Death; 2. Life-threatening (immediate risk of death); 3. Prolongation of existing hospitalization; 4. Persistent or significant disability or incapacity; OR 5. Important medical events that may not result in death, be life threatening, or require intervention or escalation of care may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias, or convulsions that do not result in inpatient hospitalization.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

56 participants

Primary outcome timeframe

14 days

Results posted on

2021-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	High-Titer (CCP1) Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment. High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.	Standard-Titer (CCP2) Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment. Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Overall Study STARTED	15	41
Overall Study Received Intervention	14	41
Overall Study Hospital Discharge	13	27
Overall Study COMPLETED	9	18
Overall Study NOT COMPLETED	6	23

Reasons for withdrawal

Reasons for withdrawal
Measure	High-Titer (CCP1) Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment. High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.	Standard-Titer (CCP2) Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment. Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Overall Study Lost to Follow-up	2	4
Overall Study Withdrawal by Subject	2	9
Overall Study Death	2	10

Baseline Characteristics

Coronavirus Disease 2019 (COVID-19) Antibody Plasma Research Study in Hospitalized Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High-Titer (CCP1) n=15 Participants Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment. High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.	Standard-Titer (CCP2) n=41 Participants Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment. Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.	Total n=56 Participants Total of all reporting groups
Age, Continuous	57 years n=5 Participants	62 years n=7 Participants	61 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	14 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	27 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	27 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	15 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	13 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	41 Participants n=7 Participants	56 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	High-Titer (CCP1) n=14 Participants Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment. High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.	Standard-Titer (CCP2) n=41 Participants Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment. Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Total Number of Serious Adverse Events (SAE) Through Study Day 14	0 Serious Adverse Events	0 Serious Adverse Events

PRIMARY outcome

Timeframe: up to 28 days

Median number of days to hospital discharge following first dose of CCP among all participants.

Outcome measures

Outcome measures
Measure	High-Titer (CCP1) n=14 Participants Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment. High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.	Standard-Titer (CCP2) n=41 Participants Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment. Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Median Time to Hospital Discharge (or Discharge Equivalent) Following First Dose of CCP	5 Days Interval 2.0 to 6.0	7 Days Interval 3.0 to 20.0

Adverse Events

High-Titer (CCP1)

Serious events: 2 serious events

Other events: 13 other events

Deaths: 2 deaths

Standard-Titer (CCP2)

Serious events: 15 serious events

Other events: 38 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	High-Titer (CCP1) n=14 participants at risk Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment. High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.	Standard-Titer (CCP2) n=41 participants at risk Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment. Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	24.4% 10/41 • Number of events 13 • From the time participants received the study intervention through Day 28.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/14 • From the time participants received the study intervention through Day 28.	7.3% 3/41 • Number of events 4 • From the time participants received the study intervention through Day 28.
Investigations Alanine aminotransferase increased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.
Investigations Aspartate aminotransferase increased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.
Investigations Blood bilirubin increased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.
Cardiac disorders Cardiac arrest	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Gastrointestinal disorders Gastrointestinal hemorrhage	0.00% 0/14 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/14 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.
Investigations Lymphocyte count decreased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 2 • From the time participants received the study intervention through Day 28.
Investigations Platelet count decreased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress	0.00% 0/14 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.

Other adverse events

Additional Information

Luther Bartelt, MD

University of North Carolina at Chapel Hill

Phone: 919-966-2537

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	High-Titer (CCP1) n=14 participants at risk Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive high-titer ABO-compatible convalescent COVID-19 plasma (CCP1) within 24 hours following random assignment. High-titer Convalescent COVID-19 Plasma (CCP1): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.	Standard-Titer (CCP2) n=41 participants at risk Within 10 days of COVID symptom onset and no more than 48 hours following hospitalization, participants will be randomized to and receive standard-titer ABO-compatible convalescent COVID-19 plasma (CCP2) within 24 hours following random assignment. Standard-titer Convalescent COVID-19 plasma (CCP2): At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
Investigations Activated partial thromboplastin time prolonged	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	9.8% 4/41 • Number of events 7 • From the time participants received the study intervention through Day 28.
Cardiac disorders Acute myocardial infarction	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Investigations Alanine aminotransferase increased	50.0% 7/14 • Number of events 8 • From the time participants received the study intervention through Day 28.	34.1% 14/41 • Number of events 18 • From the time participants received the study intervention through Day 28.
Blood and lymphatic system disorders Anemia	0.00% 0/14 • From the time participants received the study intervention through Day 28.	34.1% 14/41 • Number of events 18 • From the time participants received the study intervention through Day 28.
Investigations Aspartate aminotransferase increased	28.6% 4/14 • Number of events 5 • From the time participants received the study intervention through Day 28.	17.1% 7/41 • Number of events 8 • From the time participants received the study intervention through Day 28.
Cardiac disorders Atrial fibrillation	0.00% 0/14 • From the time participants received the study intervention through Day 28.	9.8% 4/41 • Number of events 4 • From the time participants received the study intervention through Day 28.
Infections and infestations Bacteremia	0.00% 0/14 • From the time participants received the study intervention through Day 28.	7.3% 3/41 • Number of events 3 • From the time participants received the study intervention through Day 28.
Investigations Blood albumin decreased	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	12.2% 5/41 • Number of events 5 • From the time participants received the study intervention through Day 28.
Investigations Blood bicarbonate decreased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	7.3% 3/41 • Number of events 3 • From the time participants received the study intervention through Day 28.
Investigations Blood bilirubin increased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	14.6% 6/41 • Number of events 8 • From the time participants received the study intervention through Day 28.
Investigations Blood creatinine increased	14.3% 2/14 • Number of events 2 • From the time participants received the study intervention through Day 28.	9.8% 4/41 • Number of events 4 • From the time participants received the study intervention through Day 28.
Investigations Blood potassium decreased	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Investigations Blood pressure increased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	9.8% 4/41 • Number of events 5 • From the time participants received the study intervention through Day 28.
Cardiac disorders Bradycardia	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 2 • From the time participants received the study intervention through Day 28.
Psychiatric disorders Confusional state	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Skin and subcutaneous tissue disorders Decubitus ulcer	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Psychiatric disorders Delirium	14.3% 2/14 • Number of events 2 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Blood and lymphatic system disorders Eosinophilia	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Investigations Hemoglobin decreased	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hyperglycemia	14.3% 2/14 • Number of events 2 • From the time participants received the study intervention through Day 28.	17.1% 7/41 • Number of events 7 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hyperkalemia	7.1% 1/14 • Number of events 2 • From the time participants received the study intervention through Day 28.	24.4% 10/41 • Number of events 11 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hypernatremia	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	17.1% 7/41 • Number of events 7 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/14 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 2 • From the time participants received the study intervention through Day 28.
Vascular disorders Hypertension	0.00% 0/14 • From the time participants received the study intervention through Day 28.	17.1% 7/41 • Number of events 11 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hypoalbuminemia	21.4% 3/14 • Number of events 4 • From the time participants received the study intervention through Day 28.	26.8% 11/41 • Number of events 13 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/14 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 2 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/14 • From the time participants received the study intervention through Day 28.	9.8% 4/41 • Number of events 4 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hypokalemia	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	9.8% 4/41 • Number of events 4 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hyponatremia	28.6% 4/14 • Number of events 4 • From the time participants received the study intervention through Day 28.	22.0% 9/41 • Number of events 9 • From the time participants received the study intervention through Day 28.
Metabolism and nutrition disorders Hypophosphatemia	14.3% 2/14 • Number of events 2 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 2 • From the time participants received the study intervention through Day 28.
Vascular disorders Hypotension	0.00% 0/14 • From the time participants received the study intervention through Day 28.	7.3% 3/41 • Number of events 3 • From the time participants received the study intervention through Day 28.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.
Investigations International normalized ratio increased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	17.1% 7/41 • Number of events 9 • From the time participants received the study intervention through Day 28.
Blood and lymphatic system disorders Leukopenia	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	7.3% 3/41 • Number of events 3 • From the time participants received the study intervention through Day 28.
Investigations Lymphocyte count decreased	14.3% 2/14 • Number of events 2 • From the time participants received the study intervention through Day 28.	26.8% 11/41 • Number of events 13 • From the time participants received the study intervention through Day 28.
Investigations Neutrophil count decreased	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 2 • From the time participants received the study intervention through Day 28.
Investigations Platelet count decreased	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 3 • From the time participants received the study intervention through Day 28.
Infections and infestations Pneumonia	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	9.8% 4/41 • Number of events 5 • From the time participants received the study intervention through Day 28.
Infections and infestations Pneumonia staphylococcal	0.00% 0/14 • From the time participants received the study intervention through Day 28.	7.3% 3/41 • Number of events 4 • From the time participants received the study intervention through Day 28.
Respiratory, thoracic and mediastinal disorders Pneumothorax	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Cardiac disorders Sinus tachycardia	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	2.4% 1/41 • Number of events 1 • From the time participants received the study intervention through Day 28.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/14 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 3 • From the time participants received the study intervention through Day 28.
Gastrointestinal disorders Vomiting	0.00% 0/14 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 2 • From the time participants received the study intervention through Day 28.
Investigations White blood cell count decreased	0.00% 0/14 • From the time participants received the study intervention through Day 28.	7.3% 3/41 • Number of events 3 • From the time participants received the study intervention through Day 28.
Investigations Ejection fraction decreased	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Infections and infestations Escherichia urinary tract infection	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Vascular disorders Venous occlusion	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	0.00% 0/41 • From the time participants received the study intervention through Day 28.
Investigations Blood alkaline phosphatase increased	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	9.8% 4/41 • Number of events 4 • From the time participants received the study intervention through Day 28.
Infections and infestations Pneumonia bacterial	7.1% 1/14 • Number of events 1 • From the time participants received the study intervention through Day 28.	4.9% 2/41 • Number of events 2 • From the time participants received the study intervention through Day 28.