A Study to Learn About a Repeat 5-Day Treatment With the... | NCT05567952

NCT05567952

ID	Type	Description	Link
2022-002827-36	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
nirmatrelvir plus ritonavir for 5 days	Experimental	Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days	Drug: nirmatrelvir Drug: ritonavir
placebo plus ritonavir for 5 days	Other	placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days	Drug: ritonavir Drug: placebo for nirmatrelvir

Name	Type	Description	Arm Group Labels	Other Names
nirmatrelvir	Drug	Participants will receive 2 tablets of nirmatrelvir every 12 hours	nirmatrelvir plus ritonavir for 5 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Day 5 in Viral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) Level in Nasopharyngeal (NP) Swabs: mITT Population	Baseline was defined as the latest measurement between Day -1 and Day 1, but post-dose samples that were collected within 1 hour post start of dosing were also treated as baseline. Samples with result "< lower limit of quantification (LLOQ)" were imputed as 1.7 log10 copies/milliliter (mL), and samples with result "Not Detected" were imputed as 0.0 log10 copies/mL.	Baseline, Day 5

Secondary Outcomes

Measure	Description	Time Frame
Time to Two Consecutive Negative Rapid Antigen Test (RAT) Results At Least 24 Hours Apart Through Day 28: mITT Population	The event of 2 consecutive negative RAT results obtained at least 24 (-2) hours apart through Day 28 was defined as achieving 2 consecutive non-missing RATs with negative results through Day 28, where the 2 tests were at least 22 hours and at most 7 days apart. For the event of 2 consecutive negative RAT results obtained at least 24 hours apart through Day 28, the date of the first negative RAT result was considered the first event date. Time to 2 consecutive negative RAT results obtained at least 24 hours apart defined as: for participant achieving event, time to event = (first event date) -(first dose date) + 1. For participant not achieving event (censored), censoring date was at last date of RAT measurement, time = (censoring date) - (first dose date) + 1 or Day 27 whichever occurred first (Day 27 was last possible day to achieve 2 consecutive negative RAT results obtained at least 24 hours apart through Day 28).

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
The Institute for Liver Health dba Arizona Clinical Trials		Mesa	Arizona	85210	United States
Abby's Research institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41027009	Derived	Zhang W, Terra SG, Weinstein EA, Bramson C, Leister-Tebbe H, Baniecki ML, Guan S, Agyemang A, Antonucci S, Wisemandle W, Hammond J. Retreatment With Nirmatrelvir/Ritonavir Following Return of COVID-19 Symptoms and SARS-CoV-2 Positivity. Clin Infect Dis. 2026 Feb 9;82(1):e33-e40. doi: 10.1093/cid/ciaf548.
40592258	Derived

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Nirmatrelvir 300 mg + Ritonavir 100 mg	Participants received nirmatrelvir 300 milligrams (mg) (participants with estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 30 to less than [<] 60 milliliter per minute [mL/min]/1.73 meters squared [m^2] or estimated creatinine clearance [CrCl] >=30 to <60 mL/min received 150 mg every 12 hours [q12h] for 5 days) and ritonavir 100 mg, orally for 5 days q12h from Day 1 to Day 5.

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 29, 2023	Sep 17, 2024

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

Full analysis set (FAS) included all participants randomly assigned to study intervention.

Arm/Group Information

ID	Title	Description
BG000	Nirmatrelvir 300 mg + Ritonavir 100 mg	Participants received nirmatrelvir 300 milligrams (mg) (participants with estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 30 to less than [<] 60 milliliter per minute [mL/min]/1.73 meters squared [m^2] or estimated creatinine clearance [CrCl] >=30 to <60 mL/min received 150 mg every 12 hours [q12h] for 5 days) and ritonavir 100 mg, orally for 5 days q12h from Day 1 to Day 5.
BG001	Placebo + Ritonavir 100 mg	Participants received placebo matched to nirmatrelvir followed by ritonavir 100 mg orally, for 5 days q12h from Day 1 to Day 5.
BG002	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, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00053.5± 16.52 BG00153.5± 16.43 BG00253.5± 16.47

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
12 to less than 18 years	BG0001 BG0010 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000167 BG00180 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000159 BG00172 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 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

Change From Baseline to Day 5 in Viral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) Level in Nasopharyngeal (NP) Swabs: mITT Population

Baseline was defined as the latest measurement between Day -1 and Day 1, but post-dose samples that were collected within 1 hour post start of dosing were also treated as baseline. Samples with result "< lower limit of quantification (LLOQ)" were imputed as 1.7 log10 copies/milliliter (mL), and samples with result "Not Detected" were imputed as 0.0 log10 copies/mL.

Modified intent-to-treat (mITT) analysis population included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had a positive viral RNA NP swab test result (>= 2.0 log10 copies per mL) at baseline. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

Log10 copies/mL

Baseline, Day 5

ID	Title	Description
OG000	Nirmatrelvir 300 mg + Ritonavir 100 mg	Participants received nirmatrelvir 300 milligrams (mg) (participants with estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 30 to less than [<] 60 milliliter per minute [mL/min]/1.73 meters squared [m^2] or estimated creatinine clearance [CrCl] >=30 to <60 mL/min received 150 mg every 12 hours [q12h] for 5 days) and ritonavir 100 mg, orally for 5 days q12h from Day 1 to Day 5.
OG001	Placebo + Ritonavir 100 mg	Participants received placebo matched to nirmatrelvir followed by ritonavir 100 mg orally, for 5 days q12h from Day 1 to Day 5.

Units	Counts
Participants	OG000218 OG001113

Title

Denominators

Categories

Title	Measurements
	OG000-3.871± 0.129(0.129 to ) OG001-3.166± 0.171(0.171 to )

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	Mixed model for repeated measures (MMRM) included fixed effects of treatment, geographic region, baseline SARS-CoV-2 RNA level, visit, and treatment-by-visit interaction; an unstructured (co) variance structure was used.	MMRM		= 0.0004		Least square (LS) mean difference	-0.705			2-Sided	95	-1.093	-0.316					Superiority

Secondary

Time to Two Consecutive Negative Rapid Antigen Test (RAT) Results At Least 24 Hours Apart Through Day 28: mITT Population

The event of 2 consecutive negative RAT results obtained at least 24 (-2) hours apart through Day 28 was defined as achieving 2 consecutive non-missing RATs with negative results through Day 28, where the 2 tests were at least 22 hours and at most 7 days apart. For the event of 2 consecutive negative RAT results obtained at least 24 hours apart through Day 28, the date of the first negative RAT result was considered the first event date. Time to 2 consecutive negative RAT results obtained at least 24 hours apart defined as: for participant achieving event, time to event = (first event date) -(first dose date) + 1. For participant not achieving event (censored), censoring date was at last date of RAT measurement, time = (censoring date) - (first dose date) + 1 or Day 27 whichever occurred first (Day 27 was last possible day to achieve 2 consecutive negative RAT results obtained at least 24 hours apart through Day 28).

mITT analysis population included all participants randomly assigned to study intervention who took at least 1 dose of study intervention and who had a positive viral RNA NP swab test result (>= 2.0 log10 copies per mL) at baseline. Here, ''Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.

Posted

Median

95% Confidence Interval

Days

Day 1 of dosing maximum up to Day 28 or censoring date, whichever occurred first

ID	Title	Description
OG000	Nirmatrelvir 300 mg + Ritonavir 100 mg	Participants received nirmatrelvir 300 milligrams (mg) (participants with estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 30 to less than [<] 60 milliliter per minute [mL/min]/1.73 meters squared [m^2] or estimated creatinine clearance [CrCl] >=30 to <60 mL/min received 150 mg every 12 hours [q12h] for 5 days) and ritonavir 100 mg, orally for 5 days q12h from Day 1 to Day 5.

Secondary

Time to Sustained Alleviation of All Targeted Signs and Symptoms Through Day 28: mITT Population

Sustained alleviation of all targeted COVID-19 signs/symptoms was defined as the event occurring on the first of 2 consecutive days when all symptoms scored as moderate or severe at study entry are scored as mild or absent and all symptoms scored mild or absent at study entry are scored as absent. The first day of the 2 consecutive-day period was considered the first event date. The time to sustained symptom alleviation was defined as for a participant with sustained symptom alleviation, time to event was calculated as (First Event Date) - (First Dose Date) +1. For a participant that either completed Day 28 of the study or discontinued from the study before Day 28 without sustained symptom alleviation (censored), censoring date was at the last date on which symptom alleviation was assessed, and time was calculated as (Censoring Date) - (First Dose Date) +1 or Day 27 whichever occurred first.

Posted

Median

95% Confidence Interval

Days

Day 1 of dosing maximum up to Day 28 or censoring date, whichever occurred first

ID	Title	Description
OG000	Nirmatrelvir 300 mg + Ritonavir 100 mg	Participants received nirmatrelvir 300 milligrams (mg) (participants with estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 30 to less than [<] 60 milliliter per minute [mL/min]/1.73 meters squared [m^2] or estimated creatinine clearance [CrCl] >=30 to <60 mL/min received 150 mg every 12 hours [q12h] for 5 days) and ritonavir 100 mg, orally for 5 days q12h from Day 1 to Day 5.

Secondary

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation From Study

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic. TEAEs were defined as AE that started on or after study medication on Day 1 up to Week 24 follow-up. AEs included both SAEs and all non-SAEs.

Safety population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Posted

Count of Participants

Participants

Day 1 of dosing up to maximum Week 24 follow-up

ID	Title	Description
OG000	Nirmatrelvir 300 mg + Ritonavir 100 mg	Participants received nirmatrelvir 300 milligrams (mg) (participants with estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 30 to less than [<] 60 milliliter per minute [mL/min]/1.73 meters squared [m^2] or estimated creatinine clearance [CrCl] >=30 to <60 mL/min received 150 mg every 12 hours [q12h] for 5 days) and ritonavir 100 mg, orally for 5 days q12h from Day 1 to Day 5.

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	Nirmatrelvir 300 mg + Ritonavir 100 mg	Participants received nirmatrelvir 300 milligrams (mg) (participants with estimated glomerular filtration rate [eGFR] greater than or equal to [>=] 30 to less than [<] 60 milliliter per minute [mL/min]/1.73 meters squared [m^2] or estimated creatinine clearance [CrCl] >=30 to <60 mL/min received 150 mg every 12 hours [q12h] for 5 days) and ritonavir 100 mg, orally for 5 days q12h from Day 1 to Day 5.	0	289	3	289	29	289
EG001	Placebo + Ritonavir 100 mg	Participants received placebo matched to nirmatrelvir followed by ritonavir 100 mg orally, for 5 days q12h from Day 1 to Day 5.	0	144	1	144	2	144

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected144 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA v26.1	Non-systematic Assessment	EG0000 events0 affected289 at risk EG0011 events1 affected144 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v26.1	Non-systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected144 at risk
Generalised anxiety disorder	Psychiatric disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected144 at risk
Major depression	Psychiatric disorders	MedDRA v26.1	Non-systematic Assessment	EG0001 events1 affected289 at risk EG0010 events0 affected144 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Dysgeusia	Nervous system disorders	MedDRA v26.1	Non-systematic Assessment		EG00029 events29 affected289 at risk EG0012 events2 affected144 at risk

ID	Term
D000086382	COVID-19
C000722978	COVID-19 rebound

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
C000718217	nirmatrelvir
D019438	Ritonavir

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds