SARS-CoV-2 Infection MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Participants aged 12 years or older and weighing =40 kg at screening. -Refer to Appendix 4 for reproductive criteria and contraception requirements for male (Section 10.4.1) and female (Section 10.4.2) participants. 2. Meeting 1 of the 2 categories of COVID-19 risk: (see Appendix 9, Section 10.9.2). -Category A: Immunocompromised -Category B: Non-Immunocompromised, but with =2 risk factors -Onset of signs/symptoms attributable to COVID-19 =10 days prior to the day of randomization for non-immunocompromised participants (Category B). 3.Confirmed SARS-CoV-2 infection as determined by RT-PCR or acceptable test method performed by a health care provider (See Appendix 9, Section 10.9.3) in any specimen collected within 48 hours prior to randomization. 4.Hospitalized for inpatient care for the treatment of clinical manifestations of severe COVID-19 (see Appendix 9, Section 10.9.4). Requirement for oxygen supplementation (via nasal cannula, mask, NIV or high flow oxygen) to maintain SpO2 =94% at the time of Screening and Randomization. Participants with chronic lung disease requiring home oxygen therapy are eligible if they require a higher than usual oxygen flow rate to maintain their target oxygen saturation. 5.Requirement for oxygen supplementation (via nasal cannula, mask, NIV or high flow oxygen) to maintain SpO2 =94% at the time of Screening and Randomization. Participants with chronic lung disease requiring home oxygen therapy are eligible if they require a higher than usual oxygen flow rate to maintain their target oxygen saturation. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 148 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 123
Exclusion criteria
Exclusion criteria: 1.Critical illness, defined by =1 of the following: a.Requirement for mechanical ventilation or ECMO at randomization, or likely to require IMV or ECMO within 12 hours of randomization in the judgment of the investigator, or clinical need for mechanical ventilation or ECMO, even if not able to be administered due to resource limitation at the time of randomization. b.Multi-organ dysfunction/failure. c.Hemodynamically unstable, eg. septic shock, cardiac failure or requiring vasopressors. d.Participant not expected to survive 24 hours from time of randomization 2.History of severe chronic liver disease (see Appendix 9, Section 10.9.5). 3.Receiving dialysis of any kind or severe renal impairment defined as eGFR in adults <30 mL/min/1.73 m2 or eCrCl in adolescents aged 12 to 17 years <30 mL/min (see Section 10.7.1 for the recommended formulas). 4.Confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention. 5.History of hypersensitivity or other contraindication to any of the components of the study intervention, as determined by the investigator. 6.Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the patient inappropriate for the study. 7.Use of nirmatrelvir/ritonavir as an outpatient to treat the current COVID 19 related illness =7 days of randomization. 8.Current use of any prohibited concomitant medication(s). (See Section 6.9 and Appendix 8). 9.Inability to closely monitor concentrations of immunosuppressant medications (ie, Calcineurin inhibitors and mTOR inhibitors) and adjust their doses for nirmatrelvir/ritonavir DDI during active treatment, and for at least 5 days after the last dose of study intervention. 1.Previous administration with an investigational product (drug or vaccine-) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). 11.Known prior participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of nirmatrelvir/ritonavir compared to placebo/ritonavir on SARS-CoV-2 viral RNA levels in NP swabs in hospitalized participants =12 years of age with severe COVID-19 who are immunocompromised or at increased risk for severe COVID 19 outcomes;Secondary Objective: •To evaluate the effect of nirmatrelvir/ritonavir compared to placebo/ritonavir treatment on clinical outcomes when added to background usual care, for the treatment of severe COVID 19 in hospitalized participants =12 years of age who are immunocompromised or at increased risk for severe COVID 19 outcomes. •To evaluate the effect of nirmatrelvir/ritonavir compared to placebo/ritonavir on SARS-CoV 2 viral RNA levels in NP swabs in hospitalized participants =12 years of age with severe COVID-19 who are immunocompromised or at increased risk for severe COVID 19 outcomes. •To describe the safety and tolerability of nirmatrelvir/ritonavir relative to placebo/ritonavir for the treatment of severe COVID-19 in hospitalized participants =12 years of age who are immunocompromised or at increased risk for severe COVID 19 outcomes. ;Primary end point(s): •Change from baseline in SARS CoV-2 RNA level in NP swabs at Day 5. ;Timepoint(s) of evaluation of this end point: •The difference between nirmatrelvir and placebo in mean change from baseline in SARS CoV-2 RNA level in NP swabs 5 days after the start of treatment, regardless of intercurrent events, in the population of hospitalized patients =12 years of age with severe COVID-19 who are immunocompromised or at increased risk for severe COVID 19 outcomes. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Time to sustained clinical recovery, defined as the first day during the 30 days after randomization in which a participant attains a score of 1, 2, or 3 on the 8-point ordinal scale (ie, remains alive and is either not hospitalized or is hospitalized but no longer requires ongoing inpatient medical care for COVID 19) for at least 7 consecutive days. •Proportion of participants with death from any cause or initiation of invasive mechanical ventilation or ECMO from baseline (Day 1) through Day 30. •Proportion of participants with SARS-CoV-2 RNA <LLOQ (defined as <2.0 log10 copies/mL) in NP swabs on Day 15. •Proportion of participants with sustained NP swab SARS CoV 2 RNA <LLOQ (defined as <2.0 log10 copies/mL) from Day 15 through Day 45. •Incidence of TEAEs. •Incidence of SAEs and AEs leading to discontinuations. ;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Australia, Brazil, Bulgaria, France, India, Mexico, Puerto Rico, Slovakia, Spain, United States
Contacts
Public ContactClinical Trials.gov Call Centre
Pfizer Inc.
Outcome results
None listed