C3PO: Convalescent Plasma in Outpatients With COVID-19

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT04355767
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network (Other), University of Pittsburgh (Other), Medical University of South Carolina (Other)
511
Enrollment
53
Locations
2
Arms
7.6
Actual Duration (Months)
9.6
Patients Per Site
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.

This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Convalescent Plasma
  • Biological: Saline
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
511 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical-trial of COVID-19 Convalescent Plasma in Outpatients
Actual Study Start Date :
Aug 11, 2020
Actual Primary Completion Date :
Mar 29, 2021
Actual Study Completion Date :
Mar 29, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Convalescent Plasma

Participants receive 1 unit of convalescent plasma.

Biological: Convalescent Plasma
SARS-CoV-2 convalescent plasma with neutralizing SARS-CoV2 antibodies titers of ≥1:160 administered via intravenous (IV) infusion.

Placebo Comparator: Placebo

Participants receive 1 unit of saline with multivitamin.

Biological: Saline
Saline with multivitamin administered via intravenous (IV) infusion..

Outcome Measures

Primary Outcome Measures

  1. Number of Patients With Disease Progression (Intention-to-treat Population) [15 days]

    Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.

  2. Number of Patients With Disease Progression (Per-protocol Population) [15 days]

    Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.

Secondary Outcome Measures

  1. Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization [30 days]

    This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity. 1 = Not hospitalized without limitation in activity (no symptoms) 2 = Not hospitalized with limitation in activity (continued symptoms) 3 = Hospitalized not on supplemental oxygen 4 = Hospitalized on supplemental oxygen by mask or nasal prongs 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula 6 = Hospitalized, intubated and mechanically ventilated 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) 8 = Death

  2. Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression [15 days]

    Assessed on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period. COVID Outpatient Ordinal Outcomes Scale 1 = patient requires care in the hospital 2 = patient requires care in the emergency department or urgent care 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain) 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness 5 = patient in their usual state of health

  3. Number of Hospital-free Days During the 30 Days Following Randomization [30 days]

  4. All-cause Mortality [Assessed at 30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • One or more symptoms of COVID-19 illness and laboratory-confirmed SARS-CoV-2 infection

  • Has at least one study defined risk factor for severe COVID-19 illness

  • Clinical team deems stable for outpatient management without supplemental oxygen

  • CP available at the site at the time of enrollment

  • Duration of symptoms ≤ 7 days at ED presentation

  • Informed consent from subject

Exclusion Criteria:
  • Age less than 18 years

  • Prisoner or ward of the state

  • Presumed unable to complete follow-up assessments

  • Prior adverse reaction(s) from blood product transfusion

  • Receipt of any blood product within the past 120 days

  • Treating clinical team unwilling to administer 300 ml fluid

  • Enrollment in another interventional trial for COVID-19 illness

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Chandler Regional Medical CenterChandlerArizonaUnited States85224
2Valleywise Health Medical CenterPhoenixArizonaUnited States85008
3UCSD Health La JollaLa JollaCaliforniaUnited States92037
4Loma Linda University Medical CenterLoma LindaCaliforniaUnited States92354
5Ronald Reagan UCLA Medical CenterLos AngelesCaliforniaUnited States90095
6Cedars-Sinai Medical CenterLos AngelesCaliforniaUnited States90211
7UC Davis Medical CenterSacramentoCaliforniaUnited States95817
8Stanford UniversityStanfordCaliforniaUnited States94305
9Harbor-UCLA Medical CenterTorranceCaliforniaUnited States90502
10University of Colorado HospitalAuroraColoradoUnited States80045
11UF Health Shands HospitalGainesvilleFloridaUnited States32608
12Jackson Memorial HospitalMiamiFloridaUnited States33136
13Grady Memorial HospitalAtlantaGeorgiaUnited States30303
14Rush University Medical CenterChicagoIllinoisUnited States60612
15University of Illinois HospitalChicagoIllinoisUnited States60612
16University of Chicago Medical CenterChicagoIllinoisUnited States60637
17University of Iowa Hospitals & ClinicsIowa CityIowaUnited States52242
18University of Louisville HospitalLouisvilleKentuckyUnited States40202
19Maine Medical CenterPortlandMaineUnited States04102
20Tufts Medical CenterBostonMassachusettsUnited States02111
21Beth Israel Deaconess Medical CenterBostonMassachusettsUnited States02215
22Newton-Wellesley HospitalNewtonMassachusettsUnited States02462
23Baystate Medical CenterSpringfieldMassachusettsUnited States01199
24University of Michigan University HospitalAnn ArborMichiganUnited States48109
25Detroit Receiving HospitalDetroitMichiganUnited States48201
26Harper University HospitalDetroitMichiganUnited States48201
27Henry Ford HospitalDetroitMichiganUnited States48202
28Sinai-Grace HospitalDetroitMichiganUnited States48235
29Spectrum Health Hospitals Butterworth HospitalGrand RapidsMichiganUnited States49503
30William Beaumont HospitalRoyal OakMichiganUnited States48073
31William Beaumont Hospital-TroyTroyMichiganUnited States48085
32HealthPartners Methodist HospitalSaint Louis ParkMinnesotaUnited States55426
33Regions HospitalSaint PaulMinnesotaUnited States55101
34Barnes Jewish HospitalSaint LouisMissouriUnited States63110
35Cooper University HospitalCamdenNew JerseyUnited States08103
36Robert Wood Johnson University HospitalNew BrunswickNew JerseyUnited States08901
37University of New Mexico HospitalAlbuquerqueNew MexicoUnited States87106
38SUNY Downstate Medical CenterBrooklynNew YorkUnited States11203
39Duke University HospitalDurhamNorth CarolinaUnited States27710
40Wake Forest Baptist Medical CenterWinston-SalemNorth CarolinaUnited States27103
41University of Cincinnati Medical CenterCincinnatiOhioUnited States45219
42OSU Wexner Medical CenterColumbusOhioUnited States43210
43Mercy St. Vincent Medical CenterToledoOhioUnited States43608
44Oregon Health & Science University HospitalPortlandOregonUnited States97239
45Geisinger Medical CenterDanvillePennsylvaniaUnited States17822
46Temple University HospitalPhiladelphiaPennsylvaniaUnited States19140
47Einstein Medical CenterPhiladelphiaPennsylvaniaUnited States19141
48UPMC Presbyterian HospitalPittsburghPennsylvaniaUnited States15213
49William P. Clements Jr. University HospitalDallasTexasUnited States75235
50Ben Taub General HospitalHoustonTexasUnited States77030
51Memorial Hermann Texas Medical CenterHoustonTexasUnited States77030
52University of Utah HealthcareSalt Lake CityUtahUnited States84132
53Froedtert HospitalMilwaukeeWisconsinUnited States53226

Sponsors and Collaborators

  • Stanford University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Network
  • University of Pittsburgh
  • Medical University of South Carolina

Investigators

  • Principal Investigator: Clifton W Callaway, MD, PhD, University of Pittsburgh
  • Principal Investigator: Valerie Durkalski-Mauldin, PhD, Medical University of South Carolina
  • Principal Investigator: Frederick Korley, MD, PhD, University of Michigan
  • Principal Investigator: Sharon Yeatts, PhD, Medical University of South Carolina
  • Principal Investigator: Robert Silbergleit, MD, University of Michigan
  • Principal Investigator: William Barsan, MD, University of Michigan
  • Study Director: Kevin Schulman, MD, Stanford University

Study Documents (Full-Text)

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT04355767
Other Study ID Numbers:
  • C3PO
  • 1OT2HL156812-01
First Posted:
Apr 21, 2020
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsPatients were enrolled at 48 hospital emergency departments in 21 states.
Pre-assignment Detail
Arm/Group TitleConvalescent PlasmaPlacebo
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
Period Title: Overall Study
STARTED257254
Intention-to-treat Population257254
Had Data for 15-day Outcome257254
COMPLETED250251
NOT COMPLETED73

Baseline Characteristics

Arm/Group TitleConvalescent PlasmaPlaceboTotal
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.Total of all reporting groups
Overall Participants257254511
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
54
54
54
Sex: Female, Male (Count of Participants)
Female
135
52.5%
139
54.7%
274
53.6%
Male
122
47.5%
115
45.3%
237
46.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
83
32.3%
73
28.7%
156
30.5%
Not Hispanic or Latino
170
66.1%
179
70.5%
349
68.3%
Unknown or Not Reported
4
1.6%
2
0.8%
6
1.2%
Race/Ethnicity, Customized (Count of Participants)
Asian
8
3.1%
10
3.9%
18
3.5%
Black
49
19.1%
54
21.3%
103
20.2%
Other
28
10.9%
25
9.8%
53
10.4%
White
172
66.9%
165
65%
337
65.9%
Region of Enrollment (Count of Participants)
United States
257
100%
254
100%
511
100%
Eligibility risk factor (Count of Participants)
Age .50 yr
155
60.3%
155
61%
310
60.7%
Body-mass index ≥30
152
59.1%
150
59.1%
302
59.1%
Hypertension
105
40.9%
111
43.7%
216
42.3%
Current or former tobacco use
81
31.5%
71
28%
152
29.7%
Diabetes mellitus
76
29.6%
66
26%
142
27.8%
COPD or asthma
56
21.8%
68
26.8%
124
24.3%
Coronary artery disease
28
10.9%
23
9.1%
51
10%
Immunosuppression
33
12.8%
17
6.7%
50
9.8%
Chronic lung disease
16
6.2%
15
5.9%
31
6.1%
Chronic kidney disease
16
6.2%
12
4.7%
28
5.5%
Congestive heart disease
9
3.5%
11
4.3%
20
3.9%
Currently pregnant
3
1.2%
3
1.2%
6
1.2%
Organ transplant recipient
5
1.9%
0
0%
5
1%
Active cancer
2
0.8%
2
0.8%
4
0.8%
Sickle-cell disease
1
0.4%
0
0%
1
0.2%
Number of eligibility risk factors (Count of Participants)
1
51
19.8%
66
26%
117
22.9%
3
65
25.3%
65
25.6%
130
25.4%
≥3
141
54.9%
123
48.4%
264
51.7%
Other coexisting illness (Count of Participants)
Current or former alcohol abuse
20
7.8%
16
6.3%
36
7%
Current or former drug abuse
18
7%
17
6.7%
35
6.8%
Thromboembolic disorder
15
5.8%
10
3.9%
25
4.9%
Liver disease
12
4.7%
6
2.4%
18
3.5%
Other hematologic disorder
9
3.5%
8
3.1%
17
3.3%
Symptom duration before randomization (days) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [days]
4
3
4
Interval between randomization and infusion (minutes) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [minutes]
92
69
81

Outcome Measures

1. Primary Outcome
TitleNumber of Patients With Disease Progression (Intention-to-treat Population)
DescriptionDisease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Time Frame15 days

Outcome Measure Data

Analysis Population Description
Intention-to-treat population included all randomized participants.
Arm/Group TitleConvalescent PlasmaPlacebo
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
Measure Participants257254
Patients with a disease-progression event
77
30%
81
31.9%
Hospital admission for any reason
51
19.8%
56
22%
Seeking emergency or urgent care
25
9.7%
25
9.8%
Death without hospitalization
1
0.4%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Convalescent Plasma, Placebo
Comments Analysis is of patients with a disease-progression event. The trial required a sample size of 900 patients to detect an absolute between-group difference of 10 percentage points (the minimum difference that we considered to be clinically important) with a power of 85%.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Other Statistical AnalysisA Bayesian framework was used to calculate a risk difference of 1.9 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -6.0 to 9.8. The posterior probability of superiority was calculated to be 0.68. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Convalescent Plasma, Placebo
Comments Analysis is of patients with a disease-progression event.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRisk Difference (RD)
Estimated Value2.2
Confidence Interval (2-Sided) 95%
-5.9 to 10.4
Parameter Dispersion Type:
Value:
Estimation CommentsRisk difference after adjustment for age, sex, symptom duration.
2. Primary Outcome
TitleNumber of Patients With Disease Progression (Per-protocol Population)
DescriptionDisease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Time Frame15 days

Outcome Measure Data

Analysis Population Description
Per-protocol population included all the patients who had undergone randomization after the exclusion of those who did not receive the assigned trial product, had an identified eligibility violation, or had a disease-progression event before the initiation of treatment.
Arm/Group TitleConvalescent PlasmaPlacebo
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
Measure Participants246251
Patients with a disease-progression event
71
27.6%
80
31.5%
Hospital admission for any reason
47
18.3%
55
21.7%
Seeking emergency or urgent care
24
9.3%
25
9.8%
Death without hospitalization
0
0%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Convalescent Plasma, Placebo
Comments Analysis is of patients with a disease-progression event.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Other Statistical AnalysisA Bayesian framework was used to calculate a risk difference of 3.0 percentage points (placebo group minus convalescent-plasma group) with a 95% credible interval of -4.9 to 10.8. The posterior probability of superiority was calculated to be 0.76. Efficacy was defined as a posterior probability of 0.975 or more that the proportion of patients with outcome events was higher in the placebo group.
3. Secondary Outcome
TitleWorst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following Randomization
DescriptionThis scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity. 1 = Not hospitalized without limitation in activity (no symptoms) 2 = Not hospitalized with limitation in activity (continued symptoms) 3 = Hospitalized not on supplemental oxygen 4 = Hospitalized on supplemental oxygen by mask or nasal prongs 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula 6 = Hospitalized, intubated and mechanically ventilated 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ support (pressors, renal replacement therapy) 8 = Death
Time Frame30 days

Outcome Measure Data

Analysis Population Description
Participants with available data are included in the analysis.
Arm/Group TitleConvalescent PlasmaPlacebo
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
Measure Participants250248
Severity rating 1
55
21.4%
55
21.7%
Severity rating 2
141
54.9%
133
52.4%
Severity rating 3
12
4.7%
17
6.7%
Severity rating 4
28
10.9%
35
13.8%
Severity rating 5
6
2.3%
5
2%
Severity rating 6
1
0.4%
0
0%
Severity rating 7
2
0.8%
2
0.8%
Severity rating 8
5
1.9%
1
0.4%
4. Secondary Outcome
TitleNumber of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease Progression
DescriptionAssessed on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period. COVID Outpatient Ordinal Outcomes Scale 1 = patient requires care in the hospital 2 = patient requires care in the emergency department or urgent care 3 = patient at home with symptoms rated as moderate (defined as fever, shortness of breath, abdominal pain) 4 = patient at home with symptoms rated as mild (defined as afebrile, constitutional symptoms (flu-like illness) without shortness 5 = patient in their usual state of health
Time Frame15 days

Outcome Measure Data

Analysis Population Description
Intention-to-treat population
Arm/Group TitleConvalescent PlasmaPlacebo
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
Measure Participants257254
Count of Participants [Participants]
107
41.6%
116
45.7%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Convalescent Plasma, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterHazard Ratio (HR)
Estimated Value0.90
Confidence Interval (2-Sided) 95%
0.69 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
5. Secondary Outcome
TitleNumber of Hospital-free Days During the 30 Days Following Randomization
Description
Time Frame30 days

Outcome Measure Data

Analysis Population Description
Intention-to-treat population
Arm/Group TitleConvalescent PlasmaPlacebo
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
Measure Participants257254
Mean (Standard Deviation) [days]
28.3
(4.9)
28.6
(3.6)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Convalescent Plasma, Placebo
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterMean Difference (Final Values)
Estimated Value0.3
Confidence Interval (2-Sided) 95%
-0.4 to 1.1
Parameter Dispersion Type:
Value:
Estimation Comments
6. Secondary Outcome
TitleAll-cause Mortality
Description
Time FrameAssessed at 30 days

Outcome Measure Data

Analysis Population Description
Intention-to-treat population
Arm/Group TitleConvalescent PlasmaPlacebo
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
Measure Participants257254
Count of Participants [Participants]
5
1.9%
1
0.4%

Adverse Events

Time Frame30 days
Adverse Event Reporting Description
Arm/Group TitleConvalescent PlasmaPlacebo
Arm/Group DescriptionParticipants receive 1 unit of convalescent plasma (with neutralizing SARS-CoV2 antibodies) administered via intravenous (IV) infusion.Participants receive 1 unit of saline with multivitamin administered via intravenous (IV) infusion.
All Cause Mortality
Convalescent PlasmaPlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total5/257 (1.9%) 1/254 (0.4%)
Serious Adverse Events
Convalescent PlasmaPlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total59/257 (23%) 64/254 (25.2%)
Blood and lymphatic system disorders
Anaemia0/257 (0%) 1/254 (0.4%)
Cardiac disorders
Atrial fibrillation1/257 (0.4%) 0/254 (0%)
Tachycardia0/257 (0%) 1/254 (0.4%)
Gastrointestinal disorders
Abdominal pain1/257 (0.4%) 1/254 (0.4%)
Vomiting2/257 (0.8%) 0/254 (0%)
General disorders
Fatigue1/257 (0.4%) 0/254 (0%)
Influenza like illness0/257 (0%) 1/254 (0.4%)
Immune system disorders
Anaphylactic reaction1/257 (0.4%) 0/254 (0%)
Infections and infestations
Pneumonia30/257 (11.7%) 39/254 (15.4%)
Septic shock0/257 (0%) 1/254 (0.4%)
Tooth abscess1/257 (0.4%) 0/254 (0%)
Viral diarrhoea1/257 (0.4%) 0/254 (0%)
Injury, poisoning and procedural complications
Infusion related reaction4/257 (1.6%) 0/254 (0%)
Investigations
Oesophagoscopy0/257 (0%) 1/254 (0.4%)
Metabolism and nutrition disorders
Dehydration2/257 (0.8%) 1/254 (0.4%)
Hyperglycemia1/257 (0.4%) 0/254 (0%)
Hyperkalaemia0/257 (0%) 1/254 (0.4%)
Hyponatraemia0/257 (0%) 1/254 (0.4%)
Nervous system disorders
Epilepsy1/257 (0.4%) 0/254 (0%)
Psychiatric disorders
Anxiety1/257 (0.4%) 0/254 (0%)
Psychotic disorder0/257 (0%) 1/254 (0.4%)
Renal and urinary disorders
Acute kidney injury1/257 (0.4%) 0/254 (0%)
End stage renal disease, could not get outpatient dialysis0/257 (0%) 1/254 (0.4%)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure3/257 (1.2%) 2/254 (0.8%)
Chronic obstructive pulmonary disease0/257 (0%) 1/254 (0.4%)
Dyspnea1/257 (0.4%) 8/254 (3.1%)
Epistaxis1/257 (0.4%) 0/254 (0%)
Haemoptysis0/257 (0%) 1/254 (0.4%)
Hypoxia6/257 (2.3%) 5/254 (2%)
Pulmonary embolism3/257 (1.2%) 2/254 (0.8%)
Vascular disorders
Hypotension1/257 (0.4%) 0/254 (0%)
Iliac artery occlusion0/257 (0%) 1/254 (0.4%)
Thrombophlebitis superficial0/257 (0%) 1/254 (0.4%)
Other (Not Including Serious) Adverse Events
Convalescent PlasmaPlacebo
Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total51/257 (19.8%) 35/254 (13.8%)
Ear and labyrinth disorders
Vertigo1/257 (0.4%) 0/254 (0%)
Gastrointestinal disorders
Abdominal pain1/257 (0.4%) 2/254 (0.8%)
Dysphagia1/257 (0.4%) 0/254 (0%)
Vomiting1/257 (0.4%) 3/254 (1.2%)
General disorders
Chest pain3/257 (1.2%) 7/254 (2.8%)
Fatigue2/257 (0.8%) 0/254 (0%)
Infusion site extravasation1/257 (0.4%) 0/254 (0%)
Pyrexia1/257 (0.4%) 0/254 (0%)
Infections and infestations
Nasopharyngitis1/257 (0.4%) 1/254 (0.4%)
Pneumonia7/257 (2.7%) 1/254 (0.4%)
Sinusitis1/257 (0.4%) 0/254 (0%)
Injury, poisoning and procedural complications
Alcohol poisoning1/257 (0.4%) 0/254 (0%)
Fall1/257 (0.4%) 0/254 (0%)
Infusion related reaction11/257 (4.3%) 1/254 (0.4%)
Road traffic accident1/257 (0.4%) 0/254 (0%)
Investigations
Coronavirus test positive1/257 (0.4%) 2/254 (0.8%)
Metabolism and nutrition disorders
Decreased appetite0/257 (0%) 1/254 (0.4%)
Dehydration0/257 (0%) 2/254 (0.8%)
Hyperglycemia0/257 (0%) 1/254 (0.4%)
Musculoskeletal and connective tissue disorders
Flank pain2/257 (0.8%) 0/254 (0%)
Nervous system disorders
Dizziness2/257 (0.8%) 1/254 (0.4%)
Migraine3/257 (1.2%) 1/254 (0.4%)
Presyncope0/257 (0%) 1/254 (0.4%)
Psychiatric disorders
Depression1/257 (0.4%) 0/254 (0%)
Paranoia0/257 (0%) 1/254 (0.4%)
Renal and urinary disorders
Nephrolithiasis1/257 (0.4%) 0/254 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma1/257 (0.4%) 0/254 (0%)
Bronchospasm1/257 (0.4%) 0/254 (0%)
Chronic obstructive pulmonary disease1/257 (0.4%) 0/254 (0%)
Cough0/257 (0%) 3/254 (1.2%)
Dyspnea5/257 (1.9%) 9/254 (3.5%)
Hypoxia0/257 (0%) 3/254 (1.2%)
Skin and subcutaneous tissue disorders
Ecchymosis1/257 (0.4%) 0/254 (0%)
Rash1/257 (0.4%) 0/254 (0%)
Surgical and medical procedures
Tooth extraction1/257 (0.4%) 0/254 (0%)
Vascular disorders
Venous thrombosis limb0/257 (0%) 1/254 (0.4%)

Limitations/Caveats

This study did not meet its maximum sample size of 900 participants due to a planned interim analysis that indicated that it was unlikely that there would be a difference in the rate of disease progression between the two groups if continued to the planned sample size.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleKevin Schulman, MD
OrganizationStanford University
Phone(650) 724-0543
Emailkevin.schulman@stanford.edu
Responsible Party:
Stanford University
ClinicalTrials.gov Identifier:
NCT04355767
Other Study ID Numbers:
  • C3PO
  • 1OT2HL156812-01
First Posted:
Apr 21, 2020
Last Update Posted:
Oct 19, 2021
Last Verified:
Oct 1, 2021