Octagam 10% Therapy in COVID-19 Patients With Severe Dise... | NCT04400058

NCT04400058

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

Label	Type	Description	Intervention Names
Octagam 10%	Experimental	Octagam 10%	Biological: Octagam 10%
Saline Solution	Placebo Comparator	Placebo	Other: Saline Solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Octagam 10%	Biological	Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days	Octagam 10%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7	Proportion of subjects reaching stabilization or improvement in clinical status in at least one category on a 6-point clinical status scale. Clinical status categories will be defined as: Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief). Hospitalization, not requiring supplemental oxygen. Hospitalization, requiring supplemental oxygen (but not NIV/HFNC). ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥150mmHg. ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV. Death.	7 days

Secondary Outcomes

Measure	Description	Time Frame
Length of Hospital Stay (Time to Discharge)	Median length of hospital stay in subjects treated with Octagam 10%, compared to those that received placebo from randomization through Day 33	33 days
Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult aged ≥18years old
Provide voluntary, fully informed written and signed consent before any study-related procedures are conducted
Able to understand and comply with the relevant aspects of the study protocol
Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or lower respiratory tract samples
Hospitalized with a resting room-air SpO2 of ≤93% or PaO2/FiO2 ratio <300mmHg. Measurement can be taken from documented source records in the 24 hours prior to screening
Chest imaging confirming lung involvement

Exclusion Criteria:

Existence of other evidence that can explain pneumonia including but not limited to: Influenza A virus, influenza B virus, bacterial pneumonia (as suggested by the combined clinical picture, radiological findings and known laboratory results [eg, elevated procalcitonin >0.5ng/mL and concomitant neutrophilia]), known fungal pneumonia, suspected fungal pneumonia based on compromised immune system with a history of past fungal infections, noninfectious causes, etc.
Known history of serious allergic reactions, including anaphylaxis, to IVIG or its preparation components
Subjects with a history of thromboembolic event (TEE) within the last 12 months, such as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke, transient ischemic attack, peripheral artery disease (Fontaine IV)
Subjects with an underlying medical condition that can lead to hypercoagulable states and hyperviscosity such as antithrombin III deficiency, Factor V Leiden, Protein C deficiency, antiphospholipid syndrome and malignancy
Known history of selective IgA deficiency with antibodies against IgA
Subjects with conditions such as human immunodeficiency virus (HIV) infection, known acute or chronic hepatitis B or C (HBsAg positive or HCV ribonucleic acid (RNA) PCR positive or currently treated with antivirals), pulmonary fibrosis, elevated procalcitonin (> 0.5) with concomitant neutrophilia (elevated polys), heparin induced thrombocytopenia (HIT), and moderate to severe renal dysfunction (per investigator discretion based on estimated glomerular filtration rate [eGFR] <59 mL/min/1.73 m2, as defined by KDIGO Clinical Practice Guideline):
- Moderately reduced GFR (G3a): GFR = 45 to 59 ml/min/1.73 m2
- Moderately reduced GFR (G3b): GFR = 30 to 44 ml/min/1.73 m2
- Severely reduced GFR (G4): GFR = 15 to 29 ml/min/1.73 m2
- Kidney failure (G5): GFR <15 ml/min/1.73 m2
Currently requiring IMV (invasive mechanical ventilation or having received IMV during the last 30 days
Known clinically significant preexisting lung, heart, or neuromuscular disease that, in the investigator's opinion, would impact subject's ability to complete study or may confound the study results
Body weight >125 kg
Women who are pregnant or breast-feeding
Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin agents (eg, Tocilizumab), or interferons for their COVID-19 disease before enrollment or plan to receive this treatment during the course of the study
Enrolled in other experimental interventional studies or taking experimental medications (ie, convalescent plasma). Diagnostic studies can be allowed if the anticipated total blood volume to be drawn across both studies and for therapeutic purposes does not exceed 450 mL over any 8-week period.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Octapharma Research Site		Sheffield	Alabama	35660	United States
Octapharma Research Site

References Module

No data available

No data is available for this block.

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	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
FG001	Saline Solution

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	Jan 27, 2021	Aug 14, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Saline solution placebo group

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
BG001	Saline Solution	Saline solution placebo group
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000105 BG001102 BG002207

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00057.6(26 to 83) BG00158.9(30 to 89) BG00258.2(26 to 89)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00040 BG00148 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00020 BG00121 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0011 BG002

Body Mass Index (BMI)(kg/m^2)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00031.47± 5.570 BG00132.33± 6.322 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

Proportion of Subjects Reaching Stabilization or Improvement in Clinical Status at Day 7

Proportion of subjects reaching stabilization or improvement in clinical status in at least one category on a 6-point clinical status scale.

Clinical status categories will be defined as:

Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief).
Hospitalization, not requiring supplemental oxygen.
Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).
ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥150mmHg.
ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
Death.

Posted

Count of Participants

Participants

7 days

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Units	Counts
Participants	OG000105 OG001102

Title

Denominators

Categories

Title	Measurements
	OG00089 OG00182

Secondary

Length of Hospital Stay (Time to Discharge)

Median length of hospital stay in subjects treated with Octagam 10%, compared to those that received placebo from randomization through Day 33

Posted

Median

95% Confidence Interval

days

33 days

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Units	Counts
Participants	OG000

Secondary

Number of Subjects Reaching Stabilization or Improvement In Clinical Status at Day 14

Number of subjects with maintenance or improvement by at least one category on the 6-point clinical status scale on Day 14.

Clinical status categories will be defined as:

Hospital discharge or meet discharge criteria (discharge criteria are defined as clinical recovery, i.e. no fever, respiratory rate, oxygen saturation return to normal, and cough relief).
Hospitalization, not requiring supplemental oxygen.
Hospitalization, requiring supplemental oxygen (but not NIV/HFNC).
ICU/hospitalization, requiring NIV/HFNC therapy, as defined by A-a Gradient ≥ 150 mmHg.
ICU, requiring Extracorporeal Membrane Oxygenation (ECMO) and/or IMV.
Death.

Posted

Count of Participants

Participants

14 days

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Units	Counts
Participants

Secondary

Cumulative Duration of Invasive Mechanical Venitlation (IMV)

Duration of invasive mechanical ventilation in subjects treated with Octagam 10% compared to placebo from randomization through Day 33

Posted

Mean

Standard Deviation

days

33 days

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Severe Disease Progression

Number of subjects who experienced severe disease progression while treated with Octagam 10% compared to those that received placebo at Day 33. Severe disease progression is defined as subjects requiring extracorporeal membrane oxygenation, mechanical ventilation and/or died through day 33.

Posted

Count of Participants

Participants

33 days

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Units	Counts
Participants	OG000

Secondary

ICU Stay Length

Average length of ICU stay in subjects treated with Octagam 10% compared to those that received placebo from randomization through Day 33.

Posted

Mean

Standard Deviation

days

33 days

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Units	Counts
Participants	OG000

Secondary

Cumulative Mortality Rate Through Day 33

Cumulative mortality in subjects treated with Octagam 10% compared to those that received placebo at Day 33

Posted

Count of Participants

Participants

33 days

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Units	Counts
Participants	OG000

Post-Hoc

Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 3 Months Post-Study (COVID-19 Subject Questionnaire)

Subjects who completed the core study and entered the registry were administered questionnaires at 3 months asking about their general health. Subjects were asked:

How is your general health?

Poor
Fair
Good
Very Good
Excellent
Missing

How would you compare your general health now to what it was before you were ill with Covid-19?

Much worse
Somewhat worse
The same
Somewhat better
Much better
Missing

Since last contact, have you?

Been hospitalized
Sought consultation from a health care professional
Experienced deterioration of your health without seeking HCP consultation
None of the above
Missing

If the above question was not "none of the above", was it in relation to the symptoms?

Other
Similar to the symptoms experienced during COVID-19 hospitalization

Prior to Covid-19 did you work or go to school full time?

Do you currently work or go to school full time?

Posted

Number

participants

3 months post-study

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Post-Hoc

Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 6 Months Post-Study (COVID-19 Subject Questionnaire)

Subjects who completed the core study and entered the registry were administered questionnaires at 6 months asking about their general health. Subjects were asked:

How is your general health?

Poor
Fair
Good
Very Good
Excellent
Missing

How would you compare your general health now to what it was before you were ill with Covid-19?

Much worse
Somewhat worse
The same
Somewhat better
Much better
Missing

Since last contact, have you?

Been hospitalized
Sought consultation from a health care professional
Experienced deterioration of your health without seeking HCP consultation
None of the above
Missing

If the above question was not "none of the above", was it in relation to the symptoms?

Other
Similar to the symptoms experienced during COVID-19 hospitalization

Prior to Covid-19 did you work or go to school full time?

Do you currently work or go to school full time?

Posted

Number

participants

6 months post-study

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Post-Hoc

Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 9 Months Post-Study (COVID-19 Subject Questionnaire)

Subjects who completed the core study and entered the registry were administered questionnaires at 9 months asking about their general health. Subjects were asked:

How is your general health?

Poor
Fair
Good
Very Good
Excellent
Missing

How would you compare your general health now to what it was before you were ill with Covid-19?

Much worse
Somewhat worse
The same
Somewhat better
Much better
Missing

Since last contact, have you?

Been hospitalized
Sought consultation from a health care professional
Experienced deterioration of your health without seeking HCP consultation
None of the above
Missing

If the above question was not "none of the above", was it in relation to the symptoms?

Other
Similar to the symptoms experienced during COVID-19 hospitalization

Prior to Covid-19 did you work or go to school full time?

Do you currently work or go to school full time?

Posted

Number

participants

9 months post-study

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

Post-Hoc

Post Study Health Status, Any Residual Health Effects From COVID-19 or the Study Treatment - 1 Year Post-Study (COVID-19 Subject Questionnaire)

Subjects who completed the core study and entered the registry were administered questionnaires at 1 year asking about their general health. Subjects were asked:

How is your general health?

Poor
Fair
Good
Very Good
Excellent
Missing

How would you compare your general health now to what it was before you were ill with Covid-19?

Much worse
Somewhat worse
The same
Somewhat better
Much better
Missing

Since last contact, have you?

Been hospitalized
Sought consultation from a health care professional
Experienced deterioration of your health without seeking HCP consultation
None of the above
Missing

If the above question was not "none of the above", was it in relation to the symptoms?

Other
Similar to the symptoms experienced during COVID-19 hospitalization

Prior to Covid-19 did you work or go to school full time?

Do you currently work or go to school full time?

Posted

Number

participants

1-year post-study

ID	Title	Description
OG000	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days
OG001	Placebo	Placebo Placebo: Placebo

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	Octagam 10%	Octagam 10% Octagam 10%: Octagam 10%, 2 g/kg divided by 4 days (0.5 g/kg/day), administered by intravenous infusion over approximately 2 hours per day over 4 consecutive days	13	105	15	105	49	105
EG001	Placebo	Placebo Placebo: Placebo	6	102	12	100	40	100

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG0002 events2 affected105 at risk EG0015 events5 affected100 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG0003 events3 affected105 at risk EG0011 events1 affected100 at risk
Acute Respiratory Distress Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG0003 events3 affected105 at risk EG0010 events0 affected100 at risk
Lung Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected100 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected100 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected100 at risk
Septic Shock	Infections and infestations	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0013 events3 affected100 at risk
COVID-19 Pneumonia	Infections and infestations	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected100 at risk
Pneumonia	Infections and infestations	MedDRA (23.0)	Non-systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected100 at risk
Bacterial Pneumonia	Infections and infestations	MedDRA (23.0)	Non-systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected100 at risk
Pneumococcal Pneumonia	Infections and infestations	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected100 at risk
Staphylococcal Pneumonia	Infections and infestations	MedDRA (23.0)	Non-systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected100 at risk
Viral Pneumonia	Infections and infestations	MedDRA (23.0)	Non-systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected100 at risk
Viral Cardiomyopathy	Infections and infestations	MedDRA (23.0)	Non-systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected100 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA (23.0)	Non-systematic Assessment	EG0004 events4 affected105 at risk EG0010 events0 affected100 at risk
Renal Failure	Renal and urinary disorders	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected100 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (23.0)	Non-systematic Assessment	EG0002 events2 affected105 at risk EG0010 events0 affected100 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected100 at risk
Cardiopulmonary Failure	Cardiac disorders	MedDRA (23.0)	Non-systematic Assessment	EG0000 events0 affected105 at risk EG0011 events1 affected100 at risk
Multiple Organ Dysfunction Syndrome	General disorders	MedDRA (23.0)	Non-systematic Assessment	EG0003 events3 affected105 at risk EG0010 events0 affected100 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected100 at risk
Diabetic Hyperglycaemic Coma	Nervous system disorders	MedDRA (23.0)	Non-systematic Assessment	EG0001 events1 affected105 at risk EG0010 events0 affected100 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG00010 events10 affected105 at risk EG0018 events8 affected100 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG0006 events6 affected105 at risk EG0017 events7 affected100 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA (23.0)	Non-systematic Assessment	EG0007 events7 affected105 at risk EG0014 events4 affected100 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (23.0)	Non-systematic Assessment	EG0007 events7 affected105 at risk EG0014 events4 affected100 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (23.0)	Non-systematic Assessment	EG0003 events3 affected105 at risk EG0016 events6 affected100 at risk
Anxiety	Psychiatric disorders	MedDRA (23.0)	Non-systematic Assessment	EG0008 events8 affected105 at risk EG0014 events4 affected100 at risk
Insomnia	Psychiatric disorders	MedDRA (23.0)	Non-systematic Assessment	EG0007 events7 affected105 at risk EG0015 events5 affected100 at risk
Headache	Nervous system disorders	MedDRA (23.0)	Non-systematic Assessment	EG00010 events10 affected105 at risk EG0017 events7 affected100 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA (23.0)	Non-systematic Assessment	EG0007 events7 affected105 at risk EG0015 events5 affected100 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.0)	Non-systematic Assessment	EG0004 events4 affected105 at risk EG0016 events6 affected100 at risk

Post-hoc outcomes were recorded for subjects who chose to enter the post-study phone call registry, therefore, the numbers differ from the overall study population.

Certain Agreements

First MCP Posted Date

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases
D018352	Coronavirus Infections
D003333	Coronaviridae Infections
D030341	Nidovirales Infections
D012327	RNA Virus Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D000077330	Saline Solution

Units	Counts
Participants	OG00084 OG00184

Units	Counts
Participants	OG00084 OG00184

Units	Counts
Participants	OG00084 OG00184

Units	Counts
Participants	OG00084 OG00184

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations