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0 0.25 0.5 0.75 1 1.25 1.5 1.75 2+ Hammond (DB RCT) 96% 0.04 [0.00-0.68] death 0/1,039 12/1,046 Improvement, RR [CI] Treatment Control Yip (PSW) 19% 0.81 [0.47-1.39] death/ICU Arbel 65+ 81% 0.19 [0.05-0.76] death Arbel 40-64 -64% 1.64 [0.40-12.9] death Najjar-Debbiny 46% 0.54 [0.39-0.75] severe case Pfizer (DB RCT) 67% 0.33 [0.01-8.13] death 0/576 1/569 Dryden-Peterson 45% 0.55 [0.38-0.80] hosp. 40/6,036 232/24,286 Shao 20% 0.80 [0.71-0.91] viral time 17 (n) 114 (n) OT​1 Li (ES) 79% 0.21 [0.15-0.28] viral+ 18/175 130/224 Lu 12% 0.88 [0.78-0.98] viral+ n/a n/a Tau​2 = 0.16, I​2 = 89.2%, p = 0.0002 Early treatment 45% 0.55 [0.41-0.75] 58/7,843 375/26,239 45% improvement Wong (PSM) 68% 0.32 [0.23-0.45] death 991 (n) 3,952 (n) Improvement, RR [CI] Treatment Control Li 32% 0.68 [0.47-0.98] viral+ 40/83 130/224 Tau​2 = 0.26, I​2 = 92.0%, p = 0.045 Late treatment 53% 0.47 [0.22-0.99] 40/1,074 130/4,176 53% improvement Pfizer (DB RCT) 37% 0.63 [0.40-1.00] cases 986 (n) 985 (n) Improvement, RR [CI] Treatment Control Tau​2 = 0.00, I​2 = 0.0%, p = 0.05 Prophylaxis 37% 0.63 [0.40-1.00] 0/986 0/985 37% improvement All studies 40% 0.60 [0.47-0.76] 98/9,903 505/31,400 40% improvement 13 paxlovid COVID-19 studies c19early.com/pl Aug 2022 Tau​2 = 0.12, I​2 = 85.8%, p < 0.0001 Effect extraction pre-specified(most serious outcome) 1 OT: comparison with other treatment Favors paxlovid Favors control
Paxlovid COVID-19 studies. Pfizer has denied access to Paxlovid for an independent RCT. Recent:
de Oliveira
Lu
Li
Shao
Dryden-Peterson
Pfizer
Najjar-Debbiny.
Paxlovid has been officially adopted for early treatment in 7 countries. Submit updates/corrections.
Aug 9
In Vitro de Oliveira et al., Research Square, doi:10.21203/rs.3.rs-1915291/v1 (Preprint) (In Vitro)
In Vitro
H172Y mutation perturbs the S1 pocket and nirmatrelvir binding of SARS-CoV-2 main protease through a nonnative hydrogen bond
Details   In Silico and In Vitro study of the H172Y mutation which significantly reduces paxlovid's inhibitory activity. Monotherapy with paxlovid and selective pressure may favor resistance mutations.
Aug 4
Early Lu et al., Emerging Microbes & Infections, doi:10.1080/22221751.2022.2109517
viral+, ↓12.3%, p=0.02
Geriatric risk and protective factors for serious COVID-19 outcomes among older adults in Shanghai Omicron wave
Details   Retrospective 1,377 patients in China, showing significantly faster viral clearance with Paxlovid. Authors analyze progression to severe/critical disease, but do not provide results for Paxlovid.
Jul 23
Early Li et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac600
viral+, ↓79.4%, p<0.0001
Association of nirmatrelvir/ritonavir treatment on upper respiratory SARS-CoV-2 RT-PCR negative conversion rates among high-risk patients with COVID-19
Details   Retrospective 258 paxlovid patients and 224 patients before paxlovid was available in China, showing significantly faster viral clearance with treatment. Adjusted results are only provided for subgroups (≤5, >5 days from onset). Patients ..
Jul 6
Early Shao et al., medRxiv, doi:10.1101/2022.07.03.22277169 (Preprint)
viral- time, ↓20.0%, p=0.0006
Clinical advancement of patients infected with SARS-CoV-2 Omicron variant in Shanghai, China
Details   Retrospective 17 paxlovid and 114 lianhuaqingwen patients in China, showing faster viral clearance with paxlovid.
Jun 16
Early Dryden-Peterson et al., medRxiv, doi:10.1101/2022.06.14.22276393 (Preprint)
hosp., ↓45.0%, p=0.002
Nirmatrelvir plus ritonavir for early COVID-19 and hospitalization in a large US health system
Details   IPW retrospective 30,322 age 50+ outpatients in the USA, showing lower hospitalization with paxlovid treatment.
Jun 14
Early Pfizer Press Release (News)
death, ↓66.8%, p=0.50
Pfizer announces additional phase 2/3 study results confirming robust efficacy of novel COVID-19 oral antiviral treatment candidate in reducing risk or hospitalization or death
Details   EPIC-SR update reporting that the primary endpoint was not met. Minimal details are provided.
Jun 2
Early Najjar-Debbiny et al., Clinical Infectious Diseases, doi:10.1093/cid/ciac443
severe case, ↓46.0%, p=0.0002
Effectiveness of Paxlovid in Reducing Severe COVID-19 and Mortality in High Risk Patients
Details   Retrospective 180,351 patients in Israel, 4,737 treated with paxlovid, showing significantly lower combined severe COVID-19 / mortality with treatment.
Jun 1
Early Arbel et al., Research Square, doi:10.21203/rs.3.rs-1705061/v1 (Preprint)
death, ↓81.0%, p=0.02
Oral Nirmatrelvir and Severe Covid-19 Outcomes During the Omicron Surge
Details   Retrospective 109,213 patients in Israel, 3,939 treated with nirmatrelvir, showing lower mortality and hospitalization with treatment for the subgroup of patients >65. Authors only provide subgroup results.
May 24
Early Yip et al., SSRN (Preprint)
death/ICU, ↓19.0%, p=0.45
Impact of the Use of Oral Antiviral Agents on the Risk of Hospitalisation in Community COVID-19 Patients
Details   Propensity score weighted retrospective of 93,883 outpatients in Hong Kong, 5,808 treated with molnupiravir and 4,921 treated with paxlovid, showing higher hospitalization and higher combined mortality/mechanical ventilation/ICU admission..
May 20
Late Wong et al., medRxiv, doi:10.1101/2022.05.19.22275291 (Preprint)
death, ↓68.0%, p<0.0001
Real-world effectiveness of molnupiravir and nirmatrelvir/ritonavir among COVID-19 inpatients during Hong Kong’s Omicron BA.2 wave: an observational study
Details   PSM retrospective 40,776 hospitalized patients in Hong Kong, showing lower mortality with paxlovid treatment.
Apr 29
PrEPPEP Pfizer News Release (News)
cases, ↓37.0%, p=0.05
Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use
Details   PEP RCT showing lower risk of cases with treatment, without statistical significance. The group sizes and event counts have not been provided.
Apr 4
News Ledford et al., Nature, doi:10.1038/d41586-022-00919-5 (News)
news
African clinical trial denied access to key COVID drug Paxlovid
Details   News reporting that Pfizer denied access to Paxlovid for an independent trial.
Feb 16
Early Hammond et al., New England Journal of Medicine, doi:10.1056/NEJMoa2118542
death, ↓96.0%, p=0.0005
Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19
Details   EPIC-HR RCT, 1,039 higher risk patients treated with paxlovid (PF-07321332 + ritonavir) and 1,046 control patients, showing significantly lower mortality and hospitalization with treatment. NCT04960202.
Dec 14
2021
Early Pfizer Press Release (News)
hosp., ↓70.1%, p=0.05
Pfizer announces additional phase 2/3 study results confirming robust efficacy of novel COVID-19 oral antiviral treatment candidate in reducing risk or hospitalization or death
Details   EPIC-SR trial interim results, 428 patients treated with paxlovid (PF-07321332 + ritonavir) and 426 control patients, showing lower hospitalization with treatment. NCT05011513.
Nov 30
2021
In Vitro Ullrich et al., bioRxiv, doi:10.1101/2021.11.28.4702264 (Preprint) (In Vitro)
In Vitro
Main protease mutants of SARS-CoV-2 variants remain susceptible to PF-07321332
Details   In Vitro study showing that PF-07321332 maintains efficacy against variants C.37 lambda, B.1.1.318, B.1.2, B.1.351 beta, and P.2 zeta.
Nov 5
2021
Animal Abdelnabi et al., bioRxiv, doi:10.1101/2021.11.04.467077 (Preprint)
animal study
The oral protease inhibitor (PF-07321332) protects Syrian hamsters against infection with SARS-CoV-2 variants of concern
Details   In Vitro and hamster study showing paxlovid component PF-07321332 effective against four variants of concern, inibits replication of the alpha variant in primary human airway epithelial cells, protected Syrian hamsters against intranasal ..
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