Trial Outcomes & Findings for CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients (NCT NCT04364737)

Last Updated: 2023-01-26

Results Overview

Uninfected 0 Uninfected; no viral RNA detected Ambulatory 1 Asymptomatic; viral RNA detected 2 Symptomatic; Independent 3 Symptomatic; assistance needed Hospitalized: Mild disease 4 Hospitalized; no oxygen therapy 5 Hospitalized; oxygen by mask or nasal prongs Hospitalized: Severe disease 6 Hospitalized; oxygen by NIV or High flow 7 Intubation \& Mechanical ventilation; pO2/FIO2 \>/= 150 or SpO2/FIO2 \>/=200 8 Mechanical ventilation pO2/FIO2 \< 150 (SpO2/FIO2 \<200) or vasopressors 9 Mechanical ventilation pO2/FIO2 \< 150 and vasopressors, dialysis or ECMO Death 10 Dead

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

941 participants

Primary outcome timeframe

14 days post-randomization

Results posted on

2023-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	Convalescent Donor Plasma Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; \~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate	Lactated Ringer's Solution or Sterile Saline Solution Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Overall Study STARTED	468	473
Overall Study COMPLETED	463	463
Overall Study NOT COMPLETED	5	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Convalescent Donor Plasma Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; \~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate	Lactated Ringer's Solution or Sterile Saline Solution Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Overall Study Withdrawal by Subject	4	9
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Convalescent Donor Plasma n=463 Participants Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; \~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate	Lactated Ringer's Solution or Sterile Saline Solution n=463 Participants Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.	Total n=926 Participants Total of all reporting groups
Age, Continuous	61.4 years STANDARD_DEVIATION 15.2 • n=5 Participants	63.3 years STANDARD_DEVIATION 15.1 • n=7 Participants	62.35 years STANDARD_DEVIATION 15.15 • n=5 Participants
Sex: Female, Male Female	184 Participants n=5 Participants	197 Participants n=7 Participants	381 Participants n=5 Participants
Sex: Female, Male Male	279 Participants n=5 Participants	266 Participants n=7 Participants	545 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	181 Participants n=5 Participants	186 Participants n=7 Participants	367 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	282 Participants n=5 Participants	277 Participants n=7 Participants	559 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	41 Participants n=5 Participants	30 Participants n=7 Participants	71 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	71 Participants n=5 Participants	68 Participants n=7 Participants	139 Participants n=5 Participants
Race (NIH/OMB) White	256 Participants n=5 Participants	278 Participants n=7 Participants	534 Participants n=5 Participants
Race (NIH/OMB) More than one race	76 Participants n=5 Participants	70 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Region of Enrollment United States	463 participants n=5 Participants	463 participants n=7 Participants	926 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days post-randomization

Outcome measures

Outcome measures
Measure	Convalescent Donor Plasma n=463 Participants Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; \~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate	Lactated Ringer's Solution or Sterile Saline Solution n=463 Participants Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 14 Days	2 score on a scale Interval 2.0 to 5.0	2 score on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 28 days post-randomization

Outcome measures

Outcome measures
Measure	Convalescent Donor Plasma n=462 Participants Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; \~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate	Lactated Ringer's Solution or Sterile Saline Solution n=462 Participants Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Score on the WHO 11-point Ordinal Scale for Clinical Improvement at 28 Days	2 score on a scale Interval 1.0 to 3.0	2 score on a scale Interval 1.0 to 4.0

Adverse Events

Convalescent Donor Plasma

Serious events: 112 serious events

Other events: 147 other events

Deaths: 4 deaths

Lactated Ringer's Solution or Sterile Saline Solution

Serious events: 108 serious events

Other events: 136 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Mila B. Ortigoza, MD, PhD

NYU Langone Health

Phone: 646-634-7803

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Convalescent Donor Plasma n=468 participants at risk Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; \~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate	Lactated Ringer's Solution or Sterile Saline Solution n=473 participants at risk Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Gastrointestinal disorders Abdominal wall haematoma	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Renal and urinary disorders Acute kidney injury	3.4% 16/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	4.0% 19/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Blood and lymphatic system disorders Anaemia	1.9% 9/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.7% 8/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Atrial fibrillation	3.0% 14/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.5% 7/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Bacteraemia	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	2.3% 11/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Bradycardia	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Candida pneumonia	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Cardiac arrest	13.0% 61/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	14.8% 70/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Nervous system disorders Cerebral infarction	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Nervous system disorders Cerebrovascular accident	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
General disorders Chest pain	0.85% 4/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Hepatobiliary disorders Cholecystitis	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Coronavirus test positive	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Cytomegalovirus viraemia	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
General disorders Death	0.85% 4/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Deep vein thrombosis	2.6% 12/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.3% 6/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Nervous system disorders Embolic stroke	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Injury, poisoning and procedural complications Fall	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Fibrin D dimer increased	0.85% 4/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.7% 8/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Fungaemia	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.4% 11/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Haematoma	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Renal and urinary disorders Haematuria	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Haemorrhage	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Nervous system disorders Haemorrhagic stroke	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Hepatic enzyme increased	1.1% 5/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Surgical and medical procedures Hospice care	2.4% 11/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	2.5% 12/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Surgical and medical procedures Hospitalisation	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Hypotension	8.1% 38/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	11.6% 55/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Hypoxia	14.7% 69/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	11.8% 56/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Nervous system disorders Intensive care unit acquired weakness	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Liver function test increased	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Surgical and medical procedures Lung assist device therapy	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
General disorders Multiple organ dysfunction syndrome	1.9% 9/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.5% 7/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Renal and urinary disorders Nephrolithiasis	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	1.1% 5/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Pneumonia	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Pneumonia bacterial	3.2% 15/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	5.1% 24/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Pneumonia klebsiella	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Pneumonia pseudomonal	0.85% 4/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Pneumonia staphylococcal	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.1% 10/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.9% 9/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.1% 10/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.7% 8/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Pulmonary haemorrhage	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Renal and urinary disorders Renal failure	3.6% 17/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	4.9% 23/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.8% 13/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	2.3% 11/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Respiratory failure	13.9% 65/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	16.1% 76/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Retroperitoneal haematoma	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Sepsis	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.1% 5/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Staphylococcal bacteraemia	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Supraventricular tachycardia	1.1% 5/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.5% 7/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Systemic candida	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.3% 6/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Blood and lymphatic system disorders Thrombocytopenia	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Surgical and medical procedures Tracheostomy	0.85% 4/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Urinary tract infection	1.5% 7/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	2.3% 11/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Ventricular fibrillation	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Ventricular tachycardia	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.

Measure	Convalescent Donor Plasma n=468 participants at risk Convalescent Plasma: SARS-CoV-2 convalescent plasma (1-2 units; \~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate	Lactated Ringer's Solution or Sterile Saline Solution n=473 participants at risk Saline solution: Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Renal and urinary disorders Acute kidney injury	4.9% 23/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	3.4% 16/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Alanine aminotransferase increased	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Blood and lymphatic system disorders Anaemia	2.1% 10/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.7% 8/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Aspartate aminotransferase increase	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Atrial fibrillation	2.6% 12/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.5% 7/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Bacteraemia	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Cardiac arrest	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Clostridium difficile colitis	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations C-reactive protein increased	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Cellulitis	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Deep vein thrombosis	1.9% 9/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.7% 8/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Pregnancy, puerperium and perinatal conditions Delivery	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Enterococcal bacteraemia	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Fibrin D dimer increased	0.85% 4/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Haematoma	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Hepatic enzyme increased	1.7% 8/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Vascular disorders Hypotension	1.7% 8/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.3% 6/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.4% 11/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	2.1% 10/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Blood and lymphatic system disorders Leukocytosis	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.1% 5/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Liver function test increased	2.1% 10/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	2.3% 11/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Oral candidiasis	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Pneumonia	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Pneumonia bacterial	0.85% 4/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Pneumonia klebsiella	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
General disorders Pyrexia	0.85% 4/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	1.1% 5/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.63% 3/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.1% 5/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Cardiac disorders Supraventricular tachycardia	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Injury, poisoning and procedural complications Transfusion reaction	0.64% 3/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Transaminases increased	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.42% 2/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Troponin increased	0.00% 0/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Investigations Troponin T increased	0.43% 2/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.00% 0/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.
Infections and infestations Urinary tract infection	1.3% 6/468 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.	0.85% 4/473 • 90 days from baseline Regular investigator assessment at baseline, days 1, 3, 7, 14, 28, 60, and 90.