Trial Outcomes & Findings for Elimination or Prolongation of ACE Inhibitors and ARB in Coronavirus Disease 2019 (NCT NCT04338009)

Last Updated: 2021-04-09

Results Overview

The primary endpoint of the trial will be a global rank based on patient outcomes according to four factors: (1) time to death, (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), (3) the number of days supported by renal replacement therapy or pressor/inotropic therapy, and (4) a modified sequential Organ Failure Assessment (SOFA) score. The modified SOFA score will include the cardiac, respiratory, renal and coagulation domains of the SOFA score. How to interpret the rank?: patients are ranked from worst to best outcomes, such that patients with bad outcomes are ranked at the top and patients who have the best outcomes are ranked at the bottom.

Recruitment status

COMPLETED

Study phase

Target enrollment

152 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2021-04-09

Participant Flow

Participant milestones

Participant milestones
Measure	Discontinuation Arm The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Overall Study STARTED	77	75
Overall Study COMPLETED	77	75
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Elimination or Prolongation of ACE Inhibitors and ARB in Coronavirus Disease 2019

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Discontinuation Arm n=77 Participants The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 Participants The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).	Total n=152 Participants Total of all reporting groups
Age, Customized Age	62 years STANDARD_DEVIATION 12 • n=93 Participants	62 years STANDARD_DEVIATION 12 • n=4 Participants	62 years STANDARD_DEVIATION 12 • n=27 Participants
Sex: Female, Male Female	35 Participants n=93 Participants	33 Participants n=4 Participants	68 Participants n=27 Participants
Sex: Female, Male Male	42 Participants n=93 Participants	42 Participants n=4 Participants	84 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=93 Participants	40 Participants n=4 Participants	82 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=93 Participants	35 Participants n=4 Participants	70 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Hypertension ACEI therapy (as opposed to ARB)*	38 Participants n=93 Participants	25 Participants n=4 Participants	63 Participants n=27 Participants
Hypertension Lowest recommended ACEI or ARB dose	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Hypertension Calcium channel blocker therapy	26 Participants n=93 Participants	20 Participants n=4 Participants	46 Participants n=27 Participants
Hypertension Diuretic therapy	21 Participants n=93 Participants	25 Participants n=4 Participants	46 Participants n=27 Participants
Hypertension β blocker therapy	14 Participants n=93 Participants	11 Participants n=4 Participants	25 Participants n=27 Participants
Diabetes Insulin Therapy	16 Participants n=93 Participants	20 Participants n=4 Participants	36 Participants n=27 Participants
Diabetes No insulin therapy	11 Participants n=93 Participants	22 Participants n=4 Participants	33 Participants n=27 Participants
Dyslipidemia	32 Participants n=93 Participants	34 Participants n=4 Participants	66 Participants n=27 Participants
Pre-existing cardiac disease	14 Participants n=93 Participants	10 Participants n=4 Participants	24 Participants n=27 Participants
Ischemic heart disease	12 Participants n=93 Participants	6 Participants n=4 Participants	18 Participants n=27 Participants
Heart Failure	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Atrial fibrillation	0 Participants n=93 Participants	3 Participants n=4 Participants	3 Participants n=27 Participants
Previous PE or DVT	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Obstructive sleep apnea	10 Participants n=93 Participants	7 Participants n=4 Participants	17 Participants n=27 Participants
Chronic pulmonary disease	17 Participants n=93 Participants	9 Participants n=4 Participants	26 Participants n=27 Participants
Current Smoker	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Illicit drug use	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Dyspnoea	66 Participants n=93 Participants	66 Participants n=4 Participants	132 Participants n=27 Participants
Cough	58 Participants n=93 Participants	59 Participants n=4 Participants	117 Participants n=27 Participants
Multifocal infiltrates on chest x-ray or CT	43 Participants n=93 Participants	48 Participants n=4 Participants	91 Participants n=27 Participants
Oxygen saturation	92 % of oxygen in blood STANDARD_DEVIATION 5 • n=93 Participants	92 % of oxygen in blood STANDARD_DEVIATION 8 • n=4 Participants	92 % of oxygen in blood STANDARD_DEVIATION 7 • n=27 Participants
Oxygen supplementation	60 number of subjects requiring extra O2 n=93 Participants	63 number of subjects requiring extra O2 n=4 Participants	61 number of subjects requiring extra O2 n=27 Participants
Systolic BP	133 mmHg STANDARD_DEVIATION 22 • n=93 Participants	129 mmHg STANDARD_DEVIATION 19 • n=4 Participants	131 mmHg STANDARD_DEVIATION 20 • n=27 Participants
Diastolic BP	77 mmHg STANDARD_DEVIATION 12 • n=93 Participants	75 mmHg STANDARD_DEVIATION 13 • n=4 Participants	76 mmHg STANDARD_DEVIATION 12 • n=27 Participants
Heart rate	92 bpm STANDARD_DEVIATION 17 • n=93 Participants	91 bpm STANDARD_DEVIATION 16 • n=4 Participants	91 bpm STANDARD_DEVIATION 16 • n=27 Participants
BMI	33 kg/m^2 STANDARD_DEVIATION 9 • n=93 Participants	33 kg/m^2 STANDARD_DEVIATION 7 • n=4 Participants	33 kg/m^2 STANDARD_DEVIATION 8 • n=27 Participants
eGFR	81 mL/min/1.73m^2 STANDARD_DEVIATION 25 • n=93 Participants	83 mL/min/1.73m^2 STANDARD_DEVIATION 23 • n=4 Participants	82 mL/min/1.73m^2 STANDARD_DEVIATION 24 • n=27 Participants
K Serum	4 mmol/L STANDARD_DEVIATION 0.5 • n=93 Participants	4 mmol/L STANDARD_DEVIATION 0.5 • n=4 Participants	4 mmol/L STANDARD_DEVIATION 0.5 • n=27 Participants
Leukocyte count	8.9 10^9 cells/L STANDARD_DEVIATION 4.5 • n=93 Participants	9.3 10^9 cells/L STANDARD_DEVIATION 4.3 • n=4 Participants	9.1 10^9 cells/L STANDARD_DEVIATION 4.4 • n=27 Participants
Platelets	238 10^3 cells/microL STANDARD_DEVIATION 130 • n=93 Participants	239 10^3 cells/microL STANDARD_DEVIATION 109 • n=4 Participants	238 10^3 cells/microL STANDARD_DEVIATION 119 • n=27 Participants
C reactive protein	45 mg/dL STANDARD_DEVIATION 77 • n=93 Participants	48 mg/dL STANDARD_DEVIATION 68 • n=4 Participants	46 mg/dL STANDARD_DEVIATION 72 • n=27 Participants
Days from admission to randomization	1.5 days STANDARD_DEVIATION 0.5 • n=93 Participants	1.6 days STANDARD_DEVIATION 0.9 • n=4 Participants	1.5 days STANDARD_DEVIATION 0.7 • n=27 Participants
Days from symptom onset to randomization	6.8 days STANDARD_DEVIATION 2.5 • n=93 Participants	6.5 days STANDARD_DEVIATION 2.3 • n=4 Participants	6.65 days STANDARD_DEVIATION 2.4 • n=27 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	Discontinuation Arm n=77 Participants The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 Participants The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Hierarchical Composite Endpoint	81 score on a scale (range 1 to 152) Interval 38.0 to 117.0	73 score on a scale (range 1 to 152) Interval 40.0 to 110.0

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	Discontinuation Arm n=77 Participants The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 Participants The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
All-Cause Death	10 Participants	11 Participants

SECONDARY outcome

Timeframe: Up to 28 days

This outcome measurement looked at the median length of hospitalization.

Outcome measures

Outcome measures
Measure	Discontinuation Arm n=77 Participants The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 Participants The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Length of Hospital Stay	5 days Interval 3.0 to 10.0	6 days Interval 3.0 to 11.0

SECONDARY outcome

Timeframe: Up to 28 days

Outcome measures

Outcome measures
Measure	Discontinuation Arm n=77 Participants The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 Participants The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Length of ICU Stay, Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation	15 days Interval 6.0 to 27.0	13 days Interval 6.0 to 17.0

SECONDARY outcome

Timeframe: Up to 28 days

The Area Under the Curve of the modified SOFA (AUC SOFA) from daily measurements, weighted to account for the shorter observation period among patients who die in-hospital. How to interpret the AUC SOFA?: a higher area indicates more severe disease and/or longer hospitalization.The range is 0.1 to 377.3.

Outcome measures

Outcome measures
Measure	Discontinuation Arm n=77 Participants The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 Participants The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
AUC SOFA	7 units on a scale (SOFA x days) Interval 2.0 to 20.0	12 units on a scale (SOFA x days) Interval 3.0 to 23.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

Need to be transferred to an intensive care unit or to supported by a breathing machine

Outcome measures

Outcome measures
Measure	Discontinuation Arm n=77 Participants The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 Participants The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Intensive Care Unit Admission or Respiratory Failure Requiring Mechanical Ventilation.	14 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 28 days

Hypotension Requiring Vasopressors, inotropes or mechanical hemodynamic support (ventricular assist device or intra-aortic balloon pump).

Outcome measures

Outcome measures
Measure	Discontinuation Arm n=77 Participants The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 Participants The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Hypotension Requiring Vasopressors, Inotropes or Mechanical Hemodynamic Support	8 Participants	9 Participants

Adverse Events

Discontinuation Arm

Serious events: 28 serious events

Other events: 0 other events

Deaths: 10 deaths

Continuation Arm

Serious events: 29 serious events

Other events: 0 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Discontinuation Arm n=77 participants at risk The randomized intervention will be the discontinuation of ACEI/ARBs Discontinuation of ARB/ACEI: The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.	Continuation Arm n=75 participants at risk The randomized intervention will be the continuation of ACEI/ARBs Continuation of ARB/ACEI: The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
Investigations Delirium or encephalopathy	10.4% 8/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	2.7% 2/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Cardiac disorders New or worsening congestive heart failure	1.3% 1/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	2.7% 2/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Cardiac disorders Myocarditis	2.6% 2/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	1.3% 1/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Cardiac disorders Acute myocardial infarction	0.00% 0/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	1.3% 1/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Vascular disorders Pulmonary embolism or deep vein thrombosis	1.3% 1/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	5.3% 4/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Cardiac disorders Acute arrhythmia	3.9% 3/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	8.0% 6/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Renal and urinary disorders Acute kidney injury, defined as >2-fold increase in creatinine	3.9% 3/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	4.0% 3/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Renal and urinary disorders Acute kidney injury requiring renal replacement therapy	1.3% 1/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	2.7% 2/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Vascular disorders Hypotension requiring hemodynamic support	10.4% 8/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	12.0% 9/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Respiratory, thoracic and mediastinal disorders Invasive mechanical ventilation	10.4% 8/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	13.3% 10/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
Respiratory, thoracic and mediastinal disorders Worsening dyspnoea or acute respiratory distress syndrome	16.9% 13/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	22.7% 17/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
General disorders ICU transfer	18.2% 14/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	21.3% 16/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)
General disorders All-cause death	13.0% 10/77 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)	14.7% 11/75 • until hospital discharge or up to 28 days if participant were discharged prior to this time point The research team kept a log of all adverse events in the trial. A medically-qualified investigator assessed all AEs. The definition of adverse events and Serious Adverse Events (SAE) is presented in detail in the study protocol, available in this clinicaltrials.gov record (protocol sections 5.2 and 5.3)

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jordana Cohen

University of Pennsylvania

Phone: 215-662-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60