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COVID-19Phase 2NCT05438602

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

A Phase 2 study testing Nirmatrelvir and Ritonavir in people with COVID-19, run by Pfizer at 84 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
COVID-19
What is being tested?
Nirmatrelvir and Ritonavir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
158 participants
Where
84 sitesin 9 countries
Study dates
3 Aug 2022to 13 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

84 sites in 9 countries.

84 sites in 9 countries

United States25 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University Hospital-Georgia Clinical Research Center

    Atlanta, Georgia, 30322

  • Emory University School of Medicine

    Atlanta, Georgia, 30322

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • National Institute of Health

    Bethesda, Maryland, 20892

  • South Texas Clinical Research

    Corpus Christi, Texas, 78404

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • North Texas Infectious Diseases Consultants, P.A

    Dallas, Texas, 75246

  • I.V.A.M. Clinical & Investigational Center

    Doral, Florida, 33126

  • Texas Centers for Infectious Disease Associates

    Fort Worth, Texas, 76104

  • Qway Research LLC

    Hialeah, Florida, 33010

  • Premium Medical Research Corp

    Miami, Florida, 33126

  • Global Health Clinical Trials

    Miami, Florida, 33135

  • I.V.A.M. Clinical & Investigational Center

    Miami, Florida, 33144

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • NAPA Research

    Pompano Beach, Florida, 33064

  • Beaumont Infectious Diseases Research

    Royal Oak, Michigan, 48073

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • CRS Outpatient Services UCSF

    San Francisco, California, 94143

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California, 94143

  • UCSf infectious disease Lab

    San Francisco, California, 94143

  • Fred Hutchinson Cancer Center - COVID Clinical Research Center

    Seattle, Washington, 98109

  • Revival Research Institute

    Sterling Heights, Michigan, 48312

  • Santos Research Center

    Tampa, Florida, 33615

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain13 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [LA Coruña], 15006

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona [barcelona], 08916

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña], 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [cataluña], 08041

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen de Valme

    Seville, 41014

  • Hospital Clinico de Valencia

    Valencia, Valenciana, Comunitat, 46010

  • Hospital Clinico Universitario Valencia

    Valencia, 46010

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra [pontevedra], 36312

Other trials in Spain

Slovakia12 sites

  • Narodny onkologicky ustav

    Bratislava, Bratislava Region, 833 10

  • Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda

    Bratislava, 851 07

  • Univerzitná nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda

    Bratislava, 851 07

  • ARTROMAC n. o.

    Košice, 04011

  • MEDIKOMP, s.r.o

    Prešov, 080 01

  • MUDr. Viliam Cibik, PhD., s.r.o.

    Pruské, Trenčín Region, 01852

  • REUMEX s.r.o.

    Rimavská Sobota, Banská Bystrica Region, 979 01

  • Plucna ambulancia Hrebenar s.r.o.

    Spišská Nová Ves, 052 01

  • Plucna ambulancia Hrebenar, s.r.o.

    Spišská Nová Ves, 052 01

  • SANARE spol.s.r.o.

    Svidník, 089 01

  • ALERGIA s.r.o.

    Topoľčany, Nitra Region, 955 01

  • ALERGIA s.r.o.

    Topoľčany, 955 01

Other trials in Slovakia

Canada9 sites

  • INTERMED Groupe Sante

    Chicoutimi, Quebec, G7H 7Y8

  • Dawson Clinical Research

    Guelph, Ontario, N1H 1B1

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Clinique Medicale lActuel

    Montreal, Quebec, H2L 4P9

  • Diex Recherche Sherbrooke Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Diex Recherche Trois-Rivieres Inc.

    Sherbrooke, Quebec, J1L 0H8

  • Dr. Anil K. Gupta Medicine Professional Corporation

    Toronto, Ontario, M9V 4B4

  • Vancouver Infectious Diseases Centre

    Vancouver, British Columbia, V6Z 2C7

  • Winchester District Memorial Hospital

    Winchester, Ontario, K0C 2K0

Other trials in Canada

Bulgaria7 sites

  • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD

    Haskovo, 6305

  • Diagnostic Consultative Center - 1 Lom EOOD

    Lom, Montana, 3600

  • MHAT - Heart and Brain

    Pleven, 5804

  • Medical Center Artmed

    Plovdiv, 4000

  • MHAT Sveta Karidad EAD

    Plovdiv, 4000

  • MHAT Samokov

    Samokov, Sofia, 2000

  • Military Medical Academy

    Sofia, Sofia (stolitsa), 1606

Other trials in Bulgaria

Mexico7 sites

  • Instituto de Investigaciones Clínicas para la Salud

    Durango, 34000

  • EME RED Hospitalaria

    Mérida, Yucatán, 97000

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, Mexico City, 14080

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 66460

  • Oaxaca Site Management Organization S.C.

    Oaxaca City, 68000

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900

Other trials in Mexico

Brazil5 sites

  • CECIP - Centro de Estudos do Interior Paulista

    Jaú, São Paulo, 17201130

  • Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN

    Natal, Rio Grande do Norte, 59025050

  • IBPClin - Instituto Brasil de Pesquisa Clínica

    Rio de Janeiro, 20241-180

  • Instituto Nacional de Infectologia Evandro Chagas

    Rio de Janeiro, 21040-360

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090000

Other trials in Brazil

Australia3 sites

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Royal Melbourne Hospital - Royal Park Campus

    Parkville, Victoria, 3052

Other trials in Australia

Hungary3 sites

  • Dél-Pesti Centrumkórház Országos Hematológiai és infektológiai intézet, Szent László telep

    Budapest, 1097

  • Semmelweis Egyetem

    Budapest, 1122

  • Medifarma 98 Kft

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

Other trials in Hungary

About this study

Official 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

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19.

Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen.

Read more

The study is seeking participants who:

  • Have a confirmed COVID-19 infection
  • Are Immunocompromised
  • Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.

In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir.

For this group, the study is seeking participants who:

  • Have a confirmed COVID-19 infection
  • Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir
  • The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir
  • Are Immunocompromised
  • Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.

All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 times during the study.

Conditions
COVID-19
Being tested
Nirmatrelvir, Ritonavir, Placebo for nirmatrelvir, Placebo for ritonavir
Keywords
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronavirus disease 2019 (COVID-19), Paxlovid, Nirmatrelvir, Immunocompromised
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NirmatrelvirDrug

    Participants will receive 2 tablets of nirmatrelvir every 12 hours

  • RitonavirDrug

    Participants will receive 1 capsule of ritonavir every 12 hours

  • Placebo for nirmatrelvirDrug

    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.

  • Placebo for ritonavirDrug

    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.

Study groups in NCT05438602
Study groupRoleWhat they receive
Nirmatrelvir plus ritonavir for 5 daysExperimentalNirmatrelvir (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
Receives: Drug: Nirmatrelvir; Drug: Ritonavir; Drug: Placebo for nirmatrelvir; Drug: Placebo for ritonavir
Nirmatrelvir plus ritonavir for 10 daysExperimentalNirmatrelvir (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
Receives: Drug: Nirmatrelvir; Drug: Ritonavir; Drug: Placebo for nirmatrelvir; Drug: Placebo for ritonavir
Nirmatrelvir plus ritonavir for 15 daysExperimentalNirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.
Receives: Drug: Nirmatrelvir; Drug: Ritonavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44

    NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not >=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level <LLOQ (<2.0 log10 copies/mL).

    Measured: From Day 15 to Day 44

Secondary outcomes (18)

  1. Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline

    An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is <2.0 log10 copies/mL. Kaplan-Meier method was used for analysis. Time (days) to first NP swab SARS-CoV-2 RNA<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.

    Measured: Day 1 through Day 44

  2. Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline

    An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. Sustained was defined as NP swab SARS-CoV-2 RNA level not >=2.0 log10 copies/mL at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level < LLOQ. The LLOQ is <2.0 log10 copies/mL. Time (days) to first sustained NP swab SARS-CoV-2 RNA<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.

    Measured: Day 1 through Day 44

  3. Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24

    A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA <LLOQ in Plasma by RT-PCR. The LLOQ is <2.0 log10 copies/mL.

    Measured: Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24

  4. Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44

    An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is <2.0 log10 copies/mL.

    Measured: Baseline; Days 5, 10, 15, 21, 28, 35 and 44

  5. Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44

    An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR.

    Measured: Baseline; Days 5, 10, 15, 21, 28, 35 and 44

  6. Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44

    A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA by RT-PCR.

    Measured: Baseline; Days 5, 10, 15, 21, 28, 35 and 44

  7. Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up

    Rebound in SARS-CoV-2 RNA level in NP swabs at follow up (ie, any study visit after end of treatment through Day 44) was defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level relative to end of treatment SARS-CoV-2 RNA level based on treatment regimen, with a follow-up viral RNA level >= 2.5 log10 copies/mL.

    Measured: Day 16 through Day 44

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

    An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect.

    Measured: Day 1 of dosing up to Week 24

  9. Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28

    Hospitalization >24 h is defined as >24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.

    Measured: Day 1 through Day 28

  10. Percentage of Participants With Death Through Week 24

    Death due to any cause through week 24 was considered. Kaplan-Meier method was used for evaluation.

    Measured: Day 1 through Week 24

  11. Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24

    COVID-19 related hospitalization is defined as >24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.

    Measured: Day 1 through Day 44 and Day 1 through Week 24

  12. Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24

    Measured: Day 1 through Day 44 and Day 1 through Week 24

  13. Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24

    Invasive mechanical ventilation or ECMO were types of oxygen support received in hospital.

    Measured: Day 1 through Day 44 and Day 1 through Week 24

  14. Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24

    Hospitalization >24 hours is defined as >24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19.

    Measured: Day 1 through Day 44 and Day 1 through Week 24

  15. Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24

    Measured: Day 1 through Day 44 and Day 1 through Week 24

  16. Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44

    Symptoms alleviation through day44 of each targeted COVID-19 sign/symptom was defined as first time when each targeted symptom scored as moderate/severe at study entry are scored as mild or absent and a targeted symptom scored mild or absent at study entry are scored as absent.COVID-19 targeted signs/symptoms were muscle or body aches,shortness of breath(SOB)or difficulty breathing,chills or shivering, cough,diarrhea,feeling hot or feverish,headache,nausea,stuffy or runny nose,sense of smell,sense of taste,sore throat,low energy or tiredness, vomit.

    Measured: Day 1 through Day 44

  17. Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44

    Symptoms resolution through day 44 of each targeted COVID-19 sign/symptom was defined as the first time when each targeted symptom scored as mild, moderate or severe at study entry are scored as absent. COVID -19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhoea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.

    Measured: Day 1 through Day 44

  18. Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44

    COVID-19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.

    Measured: Day 1 through Day 44

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2022
  2. Study start3 Aug 2022
  3. Primary completion17 Jul 2023
  4. Study completion13 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
158 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438602
Sponsor's protocol ID
C4671034
Other IDs
2022-001362-35
Status last verified
Sep 2024
First submitted
28 Jun 2022
Last updated
23 Sep 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Mokgokong R, Cislo P, Tudone E, Weinstein E, Cappelleri JC. Health-related quality of life in immunocompromised adults with mild-moderate COVID-19 treated with nirmatrelvir-ritonavir: results from the randomized, double-blinded EPIC-IC trial. Health Qual Life Outcomes. 2026 Mar 19;24(1):55. doi: 10.1186/s12955-026-02518-8.

    PubMed 41857593

  • Mokgokong R, Cislo P, Tudone E, Weinstein E, Cappelleri JC. Symptom Alleviation/Resolution and Returns to Usual Health/Activities in Immunocompromised Adults with COVID-19 Treated with Nirmatrelvir-Ritonavir: Results from the EPIC-IC Trial. Infect Dis Ther. 2025 Dec;14(12):2763-2783. doi: 10.1007/s40121-025-01228-w. Epub 2025 Oct 14.

    PubMed 41085942

  • Weinstein E, Paredes R, Gardner A, Almas M, Baniecki ML, Guan S, Tudone E, Antonucci S, Gregg K, Garcia-Vidal C, Camacho-Ortiz A, Wisemandle W, Terra SG, Liu S, Aberg JA, Rana MM, Corey L, Ford ES, Hammond J, Rusnak J. Extended nirmatrelvir-ritonavir treatment durations for immunocompromised patients with COVID-19 (EPIC-IC): a placebo-controlled, randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2025 Nov;25(11):1243-1253. doi: 10.1016/S1473-3099(25)00221-X. Epub 2025 Jul 14.

    PubMed 40675169

  • Baniecki ML, Guan S, Rai DK, Yang Q, Lee JT, Hao L, Weinstein E, Hyde C, Cardin RD, Soares H, Hammond J. Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19. EBioMedicine. 2025 Aug;118:105819. doi: 10.1016/j.ebiom.2025.105819. Epub 2025 Jun 30.

    PubMed 40592258

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nirmatrelvir and Ritonavir in people with COVID-19, run by Pfizer at 84 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Spain, Slovakia, Canada, Bulgaria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44 (time frame: From Day 15 to Day 44). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05438602, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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