This is a Phase 1 Study to Evaluate the Safety,Tolerabili... | NCT04593641

NCT04593641

ID	Type	Description	Link
2020-003165-19	EudraCT Number

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
Cohort 1 will receive a dose of CT-P59 or matching placebo	Experimental	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59	Biological: CT-P59
Cohort 2 will receive a dose of CT-P59 or matching placebo	Experimental	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59	Biological: CT-P59
Cohort 3 will receive a dose of CT-P59 or matching placebo	Experimental	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59	Biological: CT-P59

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT-P59	Biological	administered	Cohort 1 will receive a dose of CT-P59 or matching placebo Cohort 2 will receive a dose of CT-P59 or matching placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With TEAEs		Up to Day 14
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)		Up to Day 14
Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)		Up to Day 14
Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)		Up to Day 14

Secondary Outcomes

Measure	Description	Time Frame
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)		At Day 28
Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR		Up to Day 28

Eligibility Module

Contacts/Locations Module

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35713300	Derived	Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
34551869

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	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
FG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.

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	Jul 27, 2020	Sep 13, 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

Cohort 3 will receive a dose of CT-P59 or matching placebo

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
BG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
BG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
BG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG0005 BG0015 BG0025 BG0033 BG00418

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00059(49 to 61) BG00151(25 to 52) BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0003 BG0013 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

South Korea

Title	Measurements
	BG0005 BG0010 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 Patients With TEAEs

Safety set

Posted

Count of Participants

Participants

Up to Day 14

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts
Participants	OG0005 OG0015 OG0025 OG003

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0014 OG0023 OG003

Primary

Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)

Safety set

Posted

Count of Participants

Participants

Up to Day 14

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Primary

Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)

Safety set.

Posted

Count of Participants

Participants

Up to Day 14

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Primary

Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)

Safety set.

Posted

Count of Participants

Participants

Up to Day 14

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)

Intent-to-Treat (ITT) set.

Posted

Count of Participants

Participants

At Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR

Intent-to-Treat (ITT) set.

Posted

Mean

Standard Deviation

days

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Area Under the Concentration-time Curve of Viral Titers for qPCR

Intent-to-Treat (ITT) set.

Posted

Mean

Standard Deviation

(log10cp/mL)*days

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR

Intent-to-Treat (ITT) set.

Posted

Mean

Standard Deviation

log10cp/mL

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Number of Patients With Clinical Recovery

Intent-to-Treat (ITT) set.

Posted

Count of Participants

Participants

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Number of Patients Requiring Supplemental Oxygen

Posted

Count of Participants

Participants

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts
Participants

Secondary

Number of Patients With Intensive Care Unit Transfer

Intent-to-Treat (ITT) set.

Posted

Count of Participants

Participants

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Number of Mechanical Ventilation

Intent-to-Treat (ITT) set.

Posted

Count of Participants

Participants

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Number of Patients With All-cause Mortality

Intent-to-Treat (ITT) set.

Posted

Count of Participants

Participants

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Number of Patients With Hospital Admission

Intent-to-Treat (ITT) set.

Posted

Count of Participants

Participants

Up to Day 28

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
OG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.

Units	Counts

Secondary

Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59

The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Pharmacokinetic (PK) set.

Posted

Mean

Standard Deviation

hr*ng/mL

Up to Day 90

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.

Units	Counts
Participants

Secondary

Time to Cmax (Tmax) of CT-P59

The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Pharmacokinetic (PK) set.

Posted

Median

Full Range

Up to Day 90

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.

Units	Counts
Participants

Secondary

Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)

The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Pharmacokinetic (PK) set.

Posted

Mean

Standard Deviation

hr*ng/mL/mg

Up to Day 90

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.

Units	Counts
Participants

Secondary

Terminal Half-life (t1/2) of CT-P59

The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Posted

Mean

Standard Deviation

Up to Day 90

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.

Units	Counts
Participants	OG000

Secondary

Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59

The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Posted

Mean

Standard Deviation

Percentage of the extrapolated area

Up to Day 90

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.

Units	Counts
Participants

Secondary

Terminal Elimination Rate Constant (λz) of CT-P59

The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Pharmacokinetic (PK) set.

Posted

Mean

Standard Deviation

1/hr

Up to Day 90

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.

Units	Counts
Participants

Secondary

Total Body Clearance (CL) of CT-P59

The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Posted

Mean

Standard Deviation

mL/hr

Up to Day 90

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.

Units	Counts
Participants	OG000

Secondary

Volume of Distribution During the Elimination Phase (Vz) of CT-P59

The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).

Posted

Mean

Standard Deviation

Up to Day 90

ID	Title	Description
OG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
OG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
OG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CT-P59 20 mg/kg	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	5	5	3	5
EG001	CT-P59 40 mg/kg	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	5	5	4	5
EG002	CT-P59 80 mg/kg	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	5	5	3	5
EG003	Placebo	Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.	3	3	1	3

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG0030 affected3 at risk
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Hepatocellular injury	Hepatobiliary disorders	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Candida infection	Infections and infestations	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0021 affected5 at risk EG003
Blood creatine phosphokinase increased	Investigations	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0021 affected5 at risk EG003
Hypertriglyceridaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected5 at risk EG0011 affected5 at risk EG0020 affected5 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Insomnia	Psychiatric disorders	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003
Hypertension	Vascular disorders	Systematic Assessment	EG0000 affected5 at risk EG0010 affected5 at risk EG0020 affected5 at risk EG003

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
C000716788	regdanvimab