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| Column | Value |
|---|---|
| Trial registration number | NCT05438602 |
|
Full text link
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : June 10, 2023, 8 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 10, 2023, 8 p.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
2022-06-30 |
|
Recruitment status
Last imported at : Jan. 26, 2024, 8 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : March 1, 2023, 9:56 a.m. Source : ClinicalTrials.gov |
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. |
|
Exclusion criteria
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
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 |
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Number of arms
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Pfizer |
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Inclusion age min
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
12 |
|
Inclusion age max
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Dec. 15, 2022, noon Source : ClinicalTrials.gov |
Australia;Brazil;Bulgaria;Canada;Hungary;Mexico;Slovakia;Spain;United States |
|
Type of patients
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
|
Severity scale
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : Jan. 26, 2024, 8 a.m. Source : ClinicalTrials.gov |
157 |
|
primary outcome
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
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). |
|
Notes
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : July 1, 2022, 11 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "5 days then placebo for 10 days", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "10 days then placebo for 5 days", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "15 days", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}] |