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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05438602




Registration number
NCT05438602
Ethics application status
Date submitted
28/06/2022
Date registered
30/06/2022

Titles & IDs
Public title
A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
Scientific title
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED
Secondary ID [1] 0 0
2022-001362-35
Secondary ID [2] 0 0
C4671034
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nirmatrelvir
Treatment: Drugs - Ritonavir
Treatment: Drugs - Placebo for nirmatrelvir
Treatment: Drugs - Placebo for ritonavir

Experimental: Nirmatrelvir plus ritonavir for 5 days - Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 10 days

Experimental: Nirmatrelvir plus ritonavir for 10 days - Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days

Experimental: Nirmatrelvir plus ritonavir for 15 days - Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.


Treatment: Drugs: Nirmatrelvir
Participants will receive 2 tablets of nirmatrelvir every 12 hours

Treatment: Drugs: Ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours

Treatment: Drugs: Placebo for nirmatrelvir
Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.

Treatment: Drugs: Placebo for ritonavir
Participants will receive 1 capsule of placebo for ritonavir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of participants with sustained nasopharyngeal swab SARS-CoV-2 ribonucleic acid (RNA) <lower limit of quantitation (LLOQ) (defined as <2.0 log10 copies/mL).
Timepoint [1] 0 0
From Day 15 through Day 44
Secondary outcome [1] 0 0
Time to first nasopharyngeal swab SARS-CoV-2 RNA<LLOQ (<2.0 log10 copies/mL) for participants with nasopharyngeal swab SARS-CoV-2 RNA =LLOQ at baseline.
Timepoint [1] 0 0
Day 1 through Week 24
Secondary outcome [2] 0 0
Time to sustained nasopharyngeal swab SARS-CoV-2 RNA <LLOQ (<2.0 log10 copies/mL) for participants with nasopharyngeal swab SARS-CoV-2 RNA =LLOQ at baseline.
Timepoint [2] 0 0
Day 1 through Day 44
Secondary outcome [3] 0 0
Proportion of participants with SARS-CoV-2 RNA <LLOQ in plasma over time.
Timepoint [3] 0 0
Day 1 through Week 24
Secondary outcome [4] 0 0
Proportion of participants with SARS-CoV-2 RNA level in nasopharyngeal swabs <2.0 log10 copies/mL at each study visit.
Timepoint [4] 0 0
Day 1 through Day 44
Secondary outcome [5] 0 0
Change from baseline in SARS-CoV-2 RNA level in nasopharyngeal swabs and in plasma over time.
Timepoint [5] 0 0
Day 1 through Week 24
Secondary outcome [6] 0 0
Rebound in SARS-CoV-2 RNA level in nasopharyngeal swabs at follow up, defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level, with a follow-up viral RNA level =2.5 log10 copies/mL
Timepoint [6] 0 0
End of treatment through Day 44
Secondary outcome [7] 0 0
Incidence of treatment emergent adverse events.
Timepoint [7] 0 0
Day 1 through Week 24
Secondary outcome [8] 0 0
Incidence of serious adverse events and adverse events leading to discontinuations.
Timepoint [8] 0 0
Day 1 through Week 24
Secondary outcome [9] 0 0
Proportion of participants with COVID-19-related hospitalization >24 hours, or death from any cause.
Timepoint [9] 0 0
Day 1 through Day 28
Secondary outcome [10] 0 0
Proportion of participants with death (all cause).
Timepoint [10] 0 0
Day 1 through Week 24
Secondary outcome [11] 0 0
Proportion of participants with COVID-19-related hospitalization of any duration.
Timepoint [11] 0 0
Day 1 through Week 24
Secondary outcome [12] 0 0
Proportion of participants with COVID-19-related intensive care unit (ICU) admission of any duration.
Timepoint [12] 0 0
Day 1 through Week 24
Secondary outcome [13] 0 0
Proportion of participants requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation.
Timepoint [13] 0 0
Day 1 through Week 24
Secondary outcome [14] 0 0
Number of days in hospital and ICU stay in participants with COVID-19-related hospitalization.
Timepoint [14] 0 0
Day 1 through Week 24
Secondary outcome [15] 0 0
Plasma concentration of nirmatrelvir
Timepoint [15] 0 0
Day 1, Day 5, Day 10, and Day 15
Secondary outcome [16] 0 0
Plasma concentration of ritonavir
Timepoint [16] 0 0
Day 1, Day 5, Day 10, and Day 15
Secondary outcome [17] 0 0
Number of COVID-19-related medical visits through Day 44 and through Week 24.
Timepoint [17] 0 0
Day 1 through Day 44 and Week 24
Secondary outcome [18] 0 0
Duration of each targeted COVID-19 signs/symptoms.
Timepoint [18] 0 0
Day 1 through Day 44
Secondary outcome [19] 0 0
Proportion of participants with severe signs/symptoms attributed to COVID-19.
Timepoint [19] 0 0
Day 1 through Day 44

Eligibility
Key inclusion criteria
Inclusion Criteria (applicable for both the main population and population with rebound):

* Participants aged 12 years or older and weighing =40 kg at screening.
* Immunocompromised
* =1 signs/symptoms attributable to COVID-19 present on the day of randomization.

Participants for the main population must have:

- Confirmed SARS-CoV-2 infection as determined by RT-PCR or other acceptable test method in any specimen collected within 5 days prior to randomization for the main study population.

Participants form the rebound population must have:

- Confirmed SARS-CoV-2 infection as determined by RT-PCR or rapid antigen testing in any specimen collected within 24h prior to randomization and collected within 14 days after the completion of the initial 5-day treatment course of nirmatrelvir/ritonavir for the population with rebound.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Current need for hospitalization or anticipated need for hospitalization within 24 h after randomization
* Known medical history of active liver disease
* Known HIV infection with a viral load >400 copies/mL or taking prohibited medications for human immunodeficiency virus (HIV)
* Receiving dialysis or have known age-specific estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eCrCl) <30 mL/min/1.73 m2 at screening as measured by a serum creatinine point of care device
* Oxygen saturation of <92% on room air obtained at rest within 24 hours prior to randomization
* Current use of any prohibited concomitant medication(s)
* Females who are pregnant and <14 weeks gestation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/11/2023
Sample size
Target
Accrual to date
Final
158
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Royal Park Campus - Parkville
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Brazil
State/province [11] 0 0
RIO Grande DO Norte
Country [12] 0 0
Brazil
State/province [12] 0 0
SÃO Paulo
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio de Janeiro
Country [14] 0 0
Bulgaria
State/province [14] 0 0
Montana
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Sofia (stolitsa)
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sofia
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Haskovo
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Pleven
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Plovdiv
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Hungary
State/province [23] 0 0
Szabolcs-szatmár-bereg
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Mexico
State/province [25] 0 0
Distrito Federal
Country [26] 0 0
Mexico
State/province [26] 0 0
Nuevo LEÓN
Country [27] 0 0
Mexico
State/province [27] 0 0
Yucatán
Country [28] 0 0
Mexico
State/province [28] 0 0
Durango
Country [29] 0 0
Mexico
State/province [29] 0 0
Oaxaca
Country [30] 0 0
Mexico
State/province [30] 0 0
Veracruz
Country [31] 0 0
Slovakia
State/province [31] 0 0
Banskobystricky KRAJ
Country [32] 0 0
Slovakia
State/province [32] 0 0
Bratislavský KRAJ
Country [33] 0 0
Slovakia
State/province [33] 0 0
Nitriansky KRAJ
Country [34] 0 0
Slovakia
State/province [34] 0 0
Trenciansky KRAJ
Country [35] 0 0
Slovakia
State/province [35] 0 0
Bratislava
Country [36] 0 0
Slovakia
State/province [36] 0 0
Kosice
Country [37] 0 0
Slovakia
State/province [37] 0 0
Presov
Country [38] 0 0
Slovakia
State/province [38] 0 0
Spisska Nova Ves
Country [39] 0 0
Slovakia
State/province [39] 0 0
Svidnik
Country [40] 0 0
Slovakia
State/province [40] 0 0
Topolcany
Country [41] 0 0
Spain
State/province [41] 0 0
A Coruña [LA Coruña]
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona [barcelona]
Country [43] 0 0
Spain
State/province [43] 0 0
Catalunya [cataluña]
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid, Comunidad DE
Country [45] 0 0
Spain
State/province [45] 0 0
Pontevedra [pontevedra]
Country [46] 0 0
Spain
State/province [46] 0 0
Valenciana, Comunitat
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Madrid
Country [49] 0 0
Spain
State/province [49] 0 0
Salamanca
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT05438602