Proactive Protection With Azithromycin and hydroxyChloroq... | NCT04322396

NCT04322396

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator	This arm will receive standard care and placebo in 15 days. Azithromycin placebo: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 Hydroxychloroquine placebo: Day 1-15: 200 mg x 2	Drug: Placebo oral tablet
Intervention	Active Comparator	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 Hydroxychloroquine: Day 1-15: 200 mg x 2	Drug: Azithromycin Drug: Hydroxychloroquine

Name	Type	Description	Arm Group Labels	Other Names
Azithromycin	Drug	Azithromycin	Intervention
Hydroxychloroquine

Outcomes Module

Measure	Description	Time Frame
Number of Days Alive and Discharged From Hospital Within 14 Days		14 days

Secondary Outcomes

Measure	Description	Time Frame
Categorization of Hospitalization Status	The patient will be categorized into one of the following 8 categories depending on status of their hospitalization: Dead (yes/no) Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no) Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no) Hospitalized and given oxygen supplements different from (2) and (3) (yes/no) Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no) Hospitalized for observation (yes/no) Discharged from hospital with restriction of activity level (yes/no) Discharged from hospital without any restrictions of activity level (yes/no) Only one category can be "yes".

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Aalborg Sygehus		Aalborg			Denmark
Bispebjerg Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33081817	Derived	Sivapalan P, Ulrik CS, Lappere TS, Eklof JV, Shaker SB, Bodtger UCS, Browatzki A, Meyer CN, Weinreich UM, Laursen CB, Biering-Sorensen T, Knop FK, Lundgren JD, Jensen JS. Proactive prophylaxis with azithromycin and hydroxychloroquine in hospitalized patients with COVID-19 (ProPAC-COVID): a statistical analysis plan. Trials. 2020 Oct 20;21(1):867. doi: 10.1186/s13063-020-04795-0.
32522282

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
FG001	Intervention

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 16, 2020	Jun 15, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.

Azithromycin: Azithromycin

Hydroxychloroquine: Hydroxychloroquine

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
BG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00056 BG00161 BG002117

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	BG00063(52 to 74) BG00168(52 to 80) BG00265(52 to 77)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00027 BG00125 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race/ethnicity

Title	Measurements
Caucasian	BG00045 BG00153 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

Denmark

Title	Measurements
	BG00056 BG00161 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Days Alive and Discharged From Hospital Within 14 Days

Posted

Median

Inter-Quartile Range

days

14 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG00056 OG00161

Title

Denominators

Categories

Title	Measurements
	OG0009(7 to 10) OG0019(3 to 11)

Secondary

Categorization of Hospitalization Status

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

Dead (yes/no)
Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no)
Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no)
Hospitalized and given oxygen supplements different from (2) and (3) (yes/no)
Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no)
Hospitalized for observation (yes/no)
Discharged from hospital with restriction of activity level (yes/no)
Discharged from hospital without any restrictions of activity level (yes/no)

Only one category can be "yes".

Posted

Count of Participants

Participants

14 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts

Secondary

Length of Stay in ICU

Length of stay in intensive care unit.

Posted

Median

Inter-Quartile Range

days

14 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization

Posted

Count of Participants

Participants

14 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Mortality

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Length of Hospitalization

Posted

Median

Inter-Quartile Range

days

14 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Days Alive and Discharged From Hospital

Posted

Median

Inter-Quartile Range

days

30 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Mortality

Not Posted

90 days

Participants

Secondary

Mortality

Not Posted

365 days

Participants

Secondary

Number of Readmissions (All Causes)

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Number of Days Using Non-invasive Ventilation (NIV)

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

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

Posted

Mean

95% Confidence Interval

days

14 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Change in Patient's Oxygen Partial Pressure

PaO2 measured in arterial puncture at baseline and 4 days.

Posted

Mean

95% Confidence Interval

mmHg

4 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Change in Patient's Carbondioxide Partial Pressure

PaCO2 measured in arterial puncture at baseline and 4 days.

Posted

Mean

95% Confidence Interval

mmHg

4 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Change of pH in Blood

pH measured in arterial puncture at baseline and 4 days.

Posted

Mean

95% Confidence Interval

4 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Secondary

Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")

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

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

Posted

Median

Inter-Quartile Range

hours

14 days

ID	Title	Description
OG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine
OG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Control	This arm will receive standard care and placebo in 15 days. Placebo oral tablet: Placebo Azithromycin Placebo oral tablet: Placebo Hydroxychloroquine	2	56	2	56	25	56
EG001	Intervention	This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days. Azithromycin: Azithromycin Hydroxychloroquine: Hydroxychloroquine	1	61	0	61	31	61

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Ventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG0001 affected56 at risk EG0010 affected61 at risk
Hearing loss	Nervous system disorders	Systematic Assessment	EG0001 affected56 at risk EG0010 affected61 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 affected56 at risk EG0010 affected61 at risk
Seizure	Nervous system disorders	Systematic Assessment	EG0000 affected56 at risk EG0010 affected61 at risk
Stroke	Nervous system disorders	Systematic Assessment	EG0000 affected56 at risk EG0010 affected61 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Prolonged QTc	Cardiac disorders	Systematic Assessment	EG0007 affected56 at risk EG0014 affected61 at risk
Chest pain	Cardiac disorders	Systematic Assessment	EG0004 affected56 at risk EG0013 affected61 at risk
Hypoglycaemia	Endocrine disorders	Systematic Assessment	EG0000 affected56 at risk EG0010 affected61 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0003 affected56 at risk EG00112 affected61 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 affected56 at risk EG0012 affected61 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0006 affected56 at risk EG00111 affected61 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0007 affected56 at risk EG0017 affected61 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0005 affected56 at risk EG0013 affected61 at risk
Photophobia	Nervous system disorders	Systematic Assessment	EG0000 affected56 at risk EG0010 affected61 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0003 affected56 at risk EG00110 affected61 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected56 at risk EG0013 affected61 at risk
Itching/Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected56 at risk EG0013 affected61 at risk
Bleeding	Vascular disorders	Systematic Assessment	EG0000 affected56 at risk EG0012 affected61 at risk

Early termination based on recommendations from the DSMB leading to small numbers of subjects analyzed.

Certain Agreements

ID	Term
D014777	Virus Diseases
D018352	Coronavirus Infections

ID	Term
D017963	Azithromycin
D006886	Hydroxychloroquine

Ancestor Terms

ID	Term
D004917	Erythromycin
D018942	Macrolides
D061065	Polyketides
D007783	Lactones
D009930	Organic Chemicals
D002738	Chloroquine
D000634	Aminoquinolines
D011804	Quinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Term
D007239	Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections