Upamostat, a Serine Protease Inhibitor, or Placebo for Tr... | NCT04723537

NCT04723537

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
Part A: Upamostat 200 mg	Experimental	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days.	Drug: Part A: Upamostat 200 mg
Part A: Upamostat 400 mg	Experimental	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days.	Drug: Part A: Upamostat 400 mg
Part A: Placebo	Placebo Comparator	Each day participants will receive two matching placebos, for a total of 14 days.	Drug: Part A and B: Placebo
Part B: Upamostat	Experimental	Based on dose selected from Part A, each day participants will receive EITHER a single 200 mg dose of upamostat OR two 200 mg doses of upamostat, for a total of 14 days.	Drug: Part B: Upamostat 200 or 400 mg
Part B: Placebo	Placebo Comparator	Based on dose selected from Part A, each day participants will receive EITHER a single matching placebo OR two matching placebos, for a total of 14 days.

Name	Type	Description	Arm Group Labels	Other Names
Part A: Upamostat 200 mg	Drug	1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.	Part A: Upamostat 200 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part A - Determination of the Safety and Tolerability of Two Dose Levels and Selection of an Upamostat Dose for Part B	This is a qualitative measure that takes into account safety and tolerability based on the relative incidence and severity (CTCAE v 5.0 criteria) of adverse events, both clinical and laboratory (SOC=investigations) in each active treatment group as compared to placebo. In addition, toxicities (i.e., adverse events considered at lease possible related to study medication) resulting in dose reductions or discontinuation of therapy will be tabulated and compared among treatment groups.	57 days

Secondary Outcomes

Measure	Description	Time Frame
Hospitalization or Death From Any Cause by End of Study		57 days
Hospitalization or Death For COVID With Presence of Concerning Conditions		57 days
Time to Sustained Recovery From Symptomatic Illness for Part A (Protocol Definition)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Terry Plasse, MD	RedHill Biopharma Limited	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Beautiful Minds Clinical Research		Cutler Bay	Florida	33157	United States
Research in Miami Inc.

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36549549	Result	Plasse TF, Delgado B, Potts J, Abramson D, Fehrmann C, Fathi R, McComsey GA. A randomized, placebo-controlled pilot study of upamostat, a host-directed serine protease inhibitor, for outpatient treatment of COVID-19. Int J Infect Dis. 2023 Mar;128:148-156. doi: 10.1016/j.ijid.2022.12.003. Epub 2022 Dec 19.
37970658	Result

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
FG001	Part A: Upamostat 400 mg

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	Jun 15, 2021	Dec 17, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Drug: Part A and B: Placebo

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
BG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
BG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo
BG003	Total	Total of all reporting groups

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

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	BG00040.5(26.0 to 55.0) BG00150.0(41.0 to 60.0) BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG0019 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic/Latino

Title	Measurements
	BG00010 BG00110 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00019 BG00121 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

Part A - Determination of the Safety and Tolerability of Two Dose Levels and Selection of an Upamostat Dose for Part B

This is a qualitative measure that takes into account safety and tolerability based on the relative incidence and severity (CTCAE v 5.0 criteria) of adverse events, both clinical and laboratory (SOC=investigations) in each active treatment group as compared to placebo. In addition, toxicities (i.e., adverse events considered at lease possible related to study medication) resulting in dose reductions or discontinuation of therapy will be tabulated and compared among treatment groups.

All patients entered

Posted

Count of Participants

Participants

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Units	Counts
Participants	OG00020 OG00121 OG00220

Title

Denominators

Categories

Safe and well tolerated

Title	Measurements
	OG00020 OG00121 OG00220

Dose reductions or discontinuation of therapy

Secondary

Hospitalization or Death From Any Cause by End of Study

ITT

Posted

Count of Participants

Participants

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Units	Counts
Participants

Secondary

Hospitalization or Death For COVID With Presence of Concerning Conditions

Patient with concerning conditions per NIAID guideline

Posted

Count of Participants

Participants

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Units	Counts
Participants

Secondary

Time to Sustained Recovery From Symptomatic Illness for Part A (Protocol Definition)

Sustained recovery was defined as recovery maintained for at least 14 or 28 days (two analyses), or through end of study, whichever comes first. A patient was considered to have recovered once he or she met the following criteria:

is afebrile (<38.0°C core temperature/37.5°C oral temperature) for at least 48 hours without use of antipyretics;
all symptoms have resolved or returned to pre-illness levels (e.g., if patient had respiratory compromise prior to the onset of COVID), except for:
1. fatigue, anosmia, ageusia or dysgeusia, which may be persistent at level similar to that during the acute illness, i.e., the same level per symptom questionnaire;
2. chest pain, cough or dyspnea which if persistent must be at least one grade lower than at the start of treatment and no worse than grade 1 (mild).

ITT

Posted

Median

Inter-Quartile Range

days

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat

Secondary

Time to Sustained Recovery From Symptomatic Illness - Part A (SAP Definition)

First day at which there are no symptoms, and no occurrence of any symptoms for at least 14 days or until end of study, whichever came first. Mild symptoms which were noted as preexisting conditions were excluded from this calculation. For example, if a patient noted preexisting shortness of breath, mild shortness of breath was excluded from the calculation of no symptoms.

ITT

Posted

Median

Inter-Quartile Range

days

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Secondary

Development of New Disease-related Symptoms and/or Pneumonia on Study

ITT

Posted

Count of Participants

Participants

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Units	Counts
Participants

Secondary

Proportion of Patients Who Are PCR-negative at Day 8 From the Start of Treatment

Patients with PCR results

Posted

Count of Participants

Participants

8 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Units	Counts
Participants

Secondary

Proportion of Patients Who Are PCR-negative at Day 57 From the Start of Treatment

Patients with PCR results

Posted

Count of Participants

Participants

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Units	Counts
Participants

Secondary

Changes in D-dimer Levels, From Baseline to Day 57

Patient with D dimer results at end of study

Posted

Mean

Standard Deviation

ug/ml

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Units	Counts
Participants

Post-Hoc

Time to Sustained Recovery From Severe Symptoms - Part A

Patients with severe symptoms at baseline

Posted

Median

Inter-Quartile Range

days

57 days

ID	Title	Description
OG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
OG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat
OG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Part A: Upamostat 200 mg	Each day participants will receive a single 200 mg dose of upamostat along with a single matching placebo, for a total of 14 days. Part A: Upamostat 200 mg: 1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.	20	0	20	19	20
EG001	Part A: Upamostat 400 mg	Each day participants will receive two 200 mg doses of upamostat, for a total of 14 days. Part A: Upamostat 400 mg: 2 capsules, each capsule comprising 200 mg of upamostat	21	1	21	20	21
EG002	Part A: Placebo	Each day participants will receive two matching placebos, for a total of 14 days. Part A and B: Placebo: 1 or 2 capsules, each capsule a matching placebo	20	0	20	17	20

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 24.0	Non-systematic Assessment	Acute alcohol intoxication in a patient with a history of alcohol abuse	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Headache	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected20 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected20 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Gastrooesophageal Refulx Disease	Gastrointestinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Application Site Erythema	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected20 at risk
Application Site Irritation	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected20 at risk
Chest discomfort	General disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Conjunctivitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected20 at risk
Sinusitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0022 events2 affected20 at risk
Tonsillitis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Palpitations	Cardiac disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Genital Candisiasis	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Activated Partial Thromboplastin Time Prolonged	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0007 events7 affected20 at risk EG00110 events10 affected21 at risk EG0025 events5 affected20 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Aspartate aminotransferase	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Blood Albumin Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0012 events2 affected21 at risk EG0021 events1 affected20 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0021 events1 affected20 at risk
Blood Calcium Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0012 events2 affected21 at risk EG0021 events1 affected20 at risk
Blood Calcium Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Blood Carbon Dioxide Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0005 events5 affected20 at risk EG0010 events0 affected21 at risk EG0022 events2 affected20 at risk
Blood Chloride Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Blood Chloride Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0007 events7 affected20 at risk EG0014 events4 affected21 at risk EG0023 events3 affected20 at risk
Blood Creatinine Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Blood Glucose Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0013 events3 affected21 at risk EG0020 events0 affected20 at risk
Blood Glucose Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0012 events2 affected21 at risk EG0022 events2 affected20 at risk
Blood Lactate Dehydrogenase Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0012 events2 affected21 at risk EG0023 events3 affected20 at risk
Blood Potassium Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected21 at risk EG0021 events1 affected20 at risk
Blood Potassium Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0012 events2 affected21 at risk EG0020 events0 affected20 at risk
Blood Sodium Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Blood Sodium Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Blood Urea Nitrogen Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0012 events2 affected21 at risk EG0023 events3 affected20 at risk
C-Reactive Protein Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0005 events5 affected20 at risk EG0013 events3 affected21 at risk EG0023 events3 affected20 at risk
Fibrin D Dimer Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0007 events7 affected20 at risk EG0016 events6 affected21 at risk EG0026 events6 affected20 at risk
Haemoglobin Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0004 events4 affected20 at risk EG0015 events5 affected21 at risk EG0022 events2 affected20 at risk
Haemoglobin Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected20 at risk
International Normalized Ratio Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG00010 events10 affected20 at risk EG00110 events10 affected21 at risk EG0024 events4 affected20 at risk
Lymphocyte Count Decrease	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Monocyte Count Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0023 events3 affected20 at risk
Neutrophil Count Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0012 events2 affected21 at risk EG0021 events1 affected20 at risk
Neutrophil Count Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0013 events3 affected21 at risk EG0022 events2 affected20 at risk
Platelet Count Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Platelet Count Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0002 events2 affected20 at risk EG0011 events1 affected21 at risk EG0025 events5 affected20 at risk
Protein Total Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0007 events7 affected20 at risk EG0013 events3 affected21 at risk EG0024 events4 affected20 at risk
Protein Total Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0021 events1 affected20 at risk
Serum Ferritin Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0012 events2 affected21 at risk EG0021 events1 affected20 at risk
Serum Ferritin Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0023 events3 affected20 at risk
Transaminases Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Troponin Increased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
White Blood Cell Count Decreased	Investigations	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0014 events4 affected21 at risk EG0021 events1 affected20 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Migraine	Nervous system disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Insomnia	Psychiatric disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Heavy Menstrual Bleeding	Reproductive system and breast disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk
Throat Irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0020 events0 affected20 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Rash Vesicular	Skin and subcutaneous tissue disorders	MedDRA 24.0	Non-systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected21 at risk EG0020 events0 affected20 at risk
Hypertension	Vascular disorders	MedDRA 24.0	Non-systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected21 at risk EG0021 events1 affected20 at risk

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

BG00347.0(32.0 to 55.0)

OG00020
OG00121
OG00220

OG00020
OG00121
OG00220

OG00014
OG00114
OG00218

OG0008
OG00111
OG00210