SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-R... | NCT05629962

NCT05629962

Status Module

Label	Type	Description	Intervention Names
Bemnifosbuvir (BEM)	Experimental		Drug: Bemnifosbuvir (BEM)
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Bemnifosbuvir (BEM)	Drug	BEM tablets administered orally every 12 hours (twice a day) for a total of 5 days	Bemnifosbuvir (BEM)

Measure	Description	Time Frame
Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause		Day 1 through Day 29

Measure	Description	Time Frame
Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause		Day 1 through Day 29
Percentage of Subjects Who Died Due to Any Cause		Day 1 through Day 29; Day 1 through Day 60

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive SARS-CoV-2 test conducted ≤ 5 days prior to randomization
Mild or moderate COVID-19 with symptom onset ≤ 5 days before randomization and at least one COVID-19 related symptom present at time of screening
Subject must be high risk, defined below:
1. Age ≥70 years OR
2. Age ≥55 years with one of the following: i) obesity (body mass index [BMI] ≥30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR
3. Age 50 to 54 years with two of the following: i) obesity (BMI ≥30 kg/m2) ii) diabetes mellitus iii) cardiovascular disease or hypertension iv) chronic lung disease requiring routine therapy OR
4. Age ≥18 years with one of the following: i) Down syndrome, sickle cell disease, dementia, Parkinson's disease, or care home residents ii) One of the following immunocompromising conditions or immunosuppressive treatments: receiving chemotherapy for cancer, hematologic malignancy, being within 2 years of a hematopoietic stem cell transplant, receipt of a solid organ transplant and on immunosuppressive therapy, human immunodeficiency virus (HIV) infection untreated or with CD4+ T lymphocyte count <350 cells per cubic millimeter, moderate/severe primary immunodeficiency, taking immunosuppressive medications
Use of adequate contraception for females of childbearing potential

Exclusion Criteria:

Severe or critical COVID-19 illness
Admitted to a hospital within 90 days prior to randomization due to COVID-19
Use of other investigational drugs within 30 days prior to planned dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study
Initiation or planned initiation of remdesivir for treatment of the current SARS-CoV-2 infection
Requirement of prohibited medications, including hydroxychloroquine or amiodarone within 3 months prior to screening. Note: Subjects who had already initiated any COVID-19 drug with antiviral effects intended to treat symptomatic SARS-CoV-2 infection (≥ 24 hours prior to randomization) will be excluded. During screening (or within 24 hours prior to or after randomization), locally available COVID-19 drugs with antiviral effects (including but not limited to nirmatrelvir/ritonavir, molnupiravir, favipiravir, monoclonal antibodies) will be permitted.
Other known active viral or bacterial infection at the time of screening, such as influenza and respiratory syncytial virus (RSV). Note: This exclusion does not apply to subjects with stable chronic viral infections, such as chronic hepatitis C virus (HCV) or HIV providing other eligibility criteria are met.
Receiving dialysis or have known severe renal impairment
History of severe hepatic impairment (Child-Pugh Class C)
Known allergy or hypersensitivity to components of study drug

Facility	Status	City	State	ZIP	Country	Contacts
Atea Study Site		Kingman	Arizona	86401	United States
Atea Study Site

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
FG001	PBO - SCO Stratum

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info 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, 2023	Feb 27, 2025

Arm/Group Information

ID	Title	Description
BG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
BG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
BG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
BG003	PBO - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
BG004	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, Customized

Count of Participants

Participants

Title

Denominators

Categories

18-49 years

Title	Measurements
	BG00028 BG00130 BG0021 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000613 BG001634 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000861 BG001875 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0008 BG00111 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

Percentage of Subjects Hospitalized for Any Cause or Died Due to Any Cause

Modified intent-to-treat (mITT) population included subjects who received >= 1 dose of study drug and had >= 1 positive SARS-CoV-2 result through Day 5.

Posted

Count of Participants

Participants

Day 1 through Day 29

ID	Title	Description
OG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG003	PBO - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).

Units	Counts
Participants	OG0001022 OG0011033 OG00236 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007 OG0012 OG0020 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		0.954														Superiority

Secondary

Percentage of Subjects Hospitalized Due to COVID-19 or Died Due to Any Cause

Modified intent-to-treat (mITT) population included subjects who received >= 1 dose of study drug and had >= 1 positive SARS-CoV-2 result through Day 5.

Posted

Count of Participants

Participants

Day 1 through Day 29

ID	Title	Description
OG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG003	PBO - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).

Secondary

Percentage of Subjects Who Died Due to Any Cause

Posted

Count of Participants

Participants

Day 1 through Day 29; Day 1 through Day 60

ID	Title	Description
OG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG003	PBO - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).

Secondary

Percentage of Subjects With COVID-19-related Complications

Modified intent-to-treat (mITT) population included subjects who received >= 1 dose of study drug and had >= 1 positive SARS-CoV-2 result through Day 5.

Posted

Count of Participants

Participants

Day 1 through Day 29

ID	Title	Description
OG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG003	PBO - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).

Secondary

Percentage of Subjects With COVID-19-medically Attended Visits (Hospitalization, Emergency Room (ER) Visit, Urgent Care Visit, Physician's Office Visit, or Telemedicine Visit) or Who Died Due to Any Cause

Modified intent-to-treat (mITT) population included subjects who received >= 1 dose of study drug and had >= 1 positive SARS-CoV-2 result through Day 5.

Posted

Count of Participants

Participants

Day 1 through Day 29; Day 1 through Day 60

ID	Title	Description
OG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG003	PBO - Combo Stratum

Secondary

Percentage of Subjects With COVID-19 Symptom Relapse

Modified intent-to-treat (mITT) population included subjects who received >= 1 dose of study drug and had >= 1 positive SARS-CoV-2 result through Day 5.

Posted

Count of Participants

Participants

Day 1 through Day 29

ID	Title	Description
OG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG003	PBO - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).

Secondary

Percentage of Subjects With Viral Load Rebound

Modified intent-to-treat (mITT) population included subjects who received >= 1 dose of study drug and had >= 1 positive SARS-CoV-2 result through Day 5.

Posted

Count of Participants

Participants

Day 1 through Day 29

ID	Title	Description
OG000	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).
OG003	PBO - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)).

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	BEM - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)). Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).	3	1,093	9	1,093	39	1,093
EG001	PBO - SCO Stratum	Supportive Care Only (SCO) Stratum are subjects who did not receive any treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)). Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).	1	1,103	2	1,103	35	1,103
EG002	BEM - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)). Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).	0	37	0	37	6	37
EG003	PBO - Combo Stratum	Combination (Combo) Stratum are subjects who did receive treatment with direct SARS-CoV-2 antiviral activity in parallel with study drug (BEM or placebo (PBO)). Safety population includes all subjects who received at least one dose of the study drug (BEM or PBO).	0	36	0	36	9	36

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Bradyarrhythmia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG0030 events0 affected36 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
COVID-19	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0011 events1 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Anaesthetic complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Hypernatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,093 at risk EG0011 events1 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Renal impairment	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Renal infarct	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,093 at risk EG0010 events0 affected1,103 at risk EG0020 events0 affected37 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG00024 affected1,093 at risk EG00124 affected1,103 at risk EG0024 affected37 at risk EG0033 affected36 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00011 affected1,093 at risk EG00110 affected1,103 at risk EG0021 affected37 at risk EG003
Hypercholesterolaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected1,093 at risk EG0014 affected1,103 at risk EG0020 affected37 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 affected1,093 at risk EG0012 affected1,103 at risk EG0020 affected37 at risk EG003
Dysguesia	Nervous system disorders	Systematic Assessment	EG0000 affected1,093 at risk EG0010 affected1,103 at risk EG0023 affected37 at risk EG003

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