Trial Outcomes & Findings for Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19 (NCT NCT04322396)

NCT ID: NCT04322396

Last Updated: 2021-06-29

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 117 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2021-06-29

Participant Flow

Participant milestones

Measure	Control This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Overall Study STARTED	56	61
Overall Study COMPLETED	56	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19

Baseline characteristics by cohort

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine	Total n=117 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	68 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	36 Participants n=7 Participants	65 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Caucasian	45 Participants n=5 Participants	53 Participants n=7 Participants	98 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · African	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Asian	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Race/ethnicity · Unknown/other	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment Denmark	56 Participants n=5 Participants	61 Participants n=7 Participants	117 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Number of Days Alive and Discharged From Hospital Within 14 Days	9 days Interval 7.0 to 10.0	9 days Interval 3.0 to 11.0

SECONDARY outcome

Timeframe: 14 days

The patient will be categorized into one of the following 8 categories depending on status of their hospitalization:

1. Dead (yes/no)

2. Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no)

3. Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no)

4. Hospitalized and given oxygen supplements different from (2) and (3) (yes/no)

5. Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no)

6. Hospitalized for observation (yes/no)

7. Discharged from hospital with restriction of activity level (yes/no)

8. Discharged from hospital without any restrictions of activity level (yes/no)

Only one category can be "yes".

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Categorization of Hospitalization Status Dead	2 Participants	1 Participants
Categorization of Hospitalization Status Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO)	1 Participants	3 Participants
Categorization of Hospitalization Status Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device"	0 Participants	1 Participants
Categorization of Hospitalization Status Hospitalized and given oxygen supplements different from (2) and (3)	2 Participants	2 Participants
Categorization of Hospitalization Status Hospitalized and without oxygen, but receiving other treatment (both related to COVID-19 or other)	2 Participants	1 Participants
Categorization of Hospitalization Status Hospitalized for observation	0 Participants	1 Participants
Categorization of Hospitalization Status Discharged from hospital with restriction of activity level	27 Participants	26 Participants
Categorization of Hospitalization Status Discharged from hospital without any restrictions of activity level	22 Participants	26 Participants

SECONDARY outcome

Timeframe: 14 days

Length of stay in intensive care unit.

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Length of Stay in ICU	11 days Interval 4.0 to 14.0	14 days Interval 9.5 to 14.0

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Mortality	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 days

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Length of Hospitalization	4 days Interval 3.0 to 6.0	4 days Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Days Alive and Discharged From Hospital	26 days Interval 23.0 to 27.0	26 days Interval 21.0 to 28.0

SECONDARY outcome

Timeframe: 90 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 365 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Number of Readmissions (All Causes)	6 Participants	9 Participants

SECONDARY outcome

Timeframe: 14 days

Population: The Overall Number of Participants Analyzed represents the number of participants with available data.

Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.

Outcome measures

Measure	Control n=1 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=3 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Number of Days Using Non-invasive Ventilation (NIV)	9.0 days Only 1 patient on NIV in this group.	6.7 days Interval -9.1 to 22.4

SECONDARY outcome

Timeframe: 4 days

PaO2 measured in arterial puncture at baseline and 4 days.

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Change in Patient's Oxygen Partial Pressure	-0.2 mmHg Interval -8.3 to 7.8	-3.0 mmHg Interval -9.8 to 3.9

SECONDARY outcome

Timeframe: 4 days

PaCO2 measured in arterial puncture at baseline and 4 days.

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Change in Patient's Carbondioxide Partial Pressure	1.4 mmHg Interval -0.4 to 3.3	-3.0 mmHg Interval -9.8 to 3.9

SECONDARY outcome

Timeframe: 4 days

pH measured in arterial puncture at baseline and 4 days.

Outcome measures

Measure	Control n=56 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Change of pH in Blood	0.0 pH Interval -0.02 to 0.01	0.0 pH Interval -0.03 to 0.01

SECONDARY outcome

Timeframe: 14 days

Population: The Overall Number of Participants Analyzed represents the number of participants with available data

Time for no oxygen supplement (or regular oxygen supplement "LTOT") if on oxygen during admission.

Outcome measures

Measure	Control n=27 Participants This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=25 Participants This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")	72 hours Interval 39.75 to 96.0	72 hours Interval 24.0 to 192.0

Adverse Events

Control

Serious events: 2 serious events

Other events: 25 other events

Deaths: 2 deaths

Intervention

Serious events: 0 serious events

Other events: 31 other events

Deaths: 1 deaths

Serious adverse events

Measure	Control n=56 participants at risk This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 participants at risk This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Cardiac disorders Ventricular arrhythmia	1.8% 1/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	0.00% 0/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Nervous system disorders Hearing loss	1.8% 1/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	0.00% 0/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Cardiac disorders Myocardial infarction	0.00% 0/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	0.00% 0/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Nervous system disorders Seizure	0.00% 0/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	0.00% 0/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Nervous system disorders Stroke	0.00% 0/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	0.00% 0/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.

Other adverse events

Measure	Control n=56 participants at risk This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	Intervention n=61 participants at risk This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
Cardiac disorders Prolonged QTc	12.5% 7/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	6.6% 4/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Cardiac disorders Chest pain	7.1% 4/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	4.9% 3/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Endocrine disorders Hypoglycaemia	0.00% 0/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	0.00% 0/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Gastrointestinal disorders Diarrhoea	5.4% 3/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	19.7% 12/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Gastrointestinal disorders Vomiting	3.6% 2/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	3.3% 2/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Gastrointestinal disorders Nausea	10.7% 6/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	18.0% 11/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Gastrointestinal disorders Abdominal pain	12.5% 7/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	11.5% 7/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Nervous system disorders Headache	8.9% 5/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	4.9% 3/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Nervous system disorders Photophobia	0.00% 0/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	0.00% 0/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Nervous system disorders Dizziness	5.4% 3/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	16.4% 10/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Respiratory, thoracic and mediastinal disorders Bronchospasm	3.6% 2/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	4.9% 3/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Skin and subcutaneous tissue disorders Itching/Rash	0.00% 0/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	4.9% 3/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.
Vascular disorders Bleeding	0.00% 0/56 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.	3.3% 2/61 • Adverse events were recorded during the period beginning when the patient received their first dose of trial medication up to and including day 15. All-Cause Mortality was assessed up to 30 days. A serious adverse event (SAE) was defined as an event or adverse event that, regardless of dose, was life-threatening, resulted in significant or persistent disability or incapacity, or led to a congenital anomaly or malformation. Because comorbidities and mortality are common in this patient group, prolonged admission, re-admission, non-invasive ventilation, invasive respiratory treatment and death were not considered SAEs.

Additional Information

Prof. Jens-Ulrik Stæhr Jensen, MD PHD

Gentofte Hospital

Phone: +4538673057

Email: jens.ulrik.jensen@regionh.dk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place