A Study to Learn About a Repeat 5-Day Treatment with Nirmatrelvir/Ritonavir in People with Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment with Nirmatrelvir/Ritonavir

Phase 1

• Conditions: SARS-CoV-2 Infection; MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-002827-36-DE
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-20
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 411

Inclusion Criteria

1. Participants aged 12 years or older and weighing =40 kg at screening.
2. Participants must have written documentation with patient-reported 100% compliance (ie, completed a 5 day course of nirmatrelvir/ritonavir). They must have symptom alleviation or resolution in COVID-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir based on the judgement of both the participant and investigator.
3. The onset of rebound in COVID-19 symptoms must occur within 2 weeks (14 days) after the completion of the initial 5-day course of nirmatrelvir/ritonavir.
4. Onset of rebound in signs/symptoms attributable to COVID-19 within 48 hours prior to randomization and =1 sign/symptom attributable to COVID-19 present on the day of randomization.
5. SARS-CoV-2 infection as determined by rapid antigen testing in any specimen collected within 24 hours prior to randomization and collected within 2 weeks (14 days) after the completion of the initial 5-day treatment course of nirmatrelvir/ritonavir.
6. Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.
Are the trial subjects under 18? no
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 351
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Current need for hospitalization, hospitalized for the index COVID-19 infection, or
anticipated need for hospitalization within 24h after randomization in the clinical
opinion of the site investigator.
2. History of severe chronic liver disease (eg, jaundice, ascites, hepatic encephalopathy, history of bleeding esophageal or gastric varices). No laboratory testing is needed.
3. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator.
4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
5. Receiving dialysis or eGFR <30 mL/min/1.73m2 (for adults) or eCrCl <30 mL/min (for adolescents) at screening using creatinine point of care device.
6. Oxygen saturation of <92% on room air obtained at rest within 24 hours prior to randomization.
7. Immunocompromised.
8. 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 participant inappropriate for the study.
9. Current use of any prohibited concomitant medication(s).
10. COVID-19 vaccination within 14 days prior to study entry or anticipated COVID-19 vaccination through Day 34.
11. Receiving other COVID-19 specific treatments within 30 days of randomization and through Day 34, excluding the initial course of nirmatrelvir/ritonavir as well as blinded study medication.
12. Prior participation in this trial.
13. Current or 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).
14. Females who are pregnant up to 14 weeks gestation. Pregnancy =14 weeks is not exclusionary.
15. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified