Introduction
Methods
SLR objectives
Data sources and search strategy
Study selection
Domain | Criteria | Exclusion reason | Exclusion description |
---|---|---|---|
Populations | Patients aged ≥ 12 years who fulfill the following criteria: Identified as having confirmed COVID-19 Have received sotrovimab for treatment of SARS-CoV-2 infection as per standard of care Presented with the BA.2 subvariant onwards, or had COVID-19 during BA.2 subvariant and onwards dominant period Subgroups of interest: Subgroup within high-risk group (i.e., transplant patients, renal patients) | Population not of interest | Patients aged < 12 years |
Interventions/comparators | All studies with patients treated with sotrovimab 500 mg IV (n ≥ 20) | No treatment of interest | Did not receive sotrovimab Received sotrovimab as a prophylactic treatment, or for primary treatment of severe COVID-19 Fewer than 20 patients treated with sotrovimab |
Outcomes | Any of the following clinical outcomes within 30 days of sotrovimab: Hospitalization and/or mortality (all-cause or COVID-19-related) Intensive care admission Emergency department visits Respiratory support (e.g., use of supplemental oxygen) COVID-19 progression (e.g., composite endpoint such as ICU/respiratory support/mortality) | Outcomes not of interest | Relevant outcomes are not reported |
Study design | Any of the following study designs: Observational studies (including sotrovimab-treated single-arm studies and comparative effectiveness studies) SLRs with or without meta-analysis (for citation chasing of observational studies only) | Publication type not of interest Study design not of interest | Case report, editorial, opinion piece, letter to the editor, clinical trial, narrative review, guidelines Pre-clinical studies (animal, in vitro, ex vivo, pharmacokinetics) Clinical trials |
Data extraction and quality assessment
Results
Study selection
Study characteristics
Author, year | Country (region) | Study design/clinical outcomes assessed | Analytical methods summary | Data source | Study time period | Stated BA.2 and BA.5 prevalence (%) during time period (ecological studies) | Population | Sotrovimab/comparator | Sample size (N) | BA.2 and BA.5 sample size (N) | Key baseline characteristics |
---|---|---|---|---|---|---|---|---|---|---|---|
Cheng et al., 2023 [26] (peer- reviewed) | US (all) | Observational comparative effectiveness cohort study All-cause hospitalization within 30 days of claimed COVID-19 diagnosis; 30-day faculty-reported all-cause mortality; composite of 30-day all-cause hospitalization or mortality | Multivariate and propensity score matched (1:4) regression analyses | FAIR Health claims database | Sept 1, 2021 to Apr 30, 2022 | Monthly average US prevalence: Mar 22: ~ 50% Apr 22: ~ 100% | High-risk patients (based on EUA criteria) diagnosed with COVID-19 | Sotrovimab (S) No mAb | S: 15,633 No mAb: 1,514,868 (62,532 for matched cohort) | BA.2 S: 1,114 No mAb: 182,759 (Ecological) Mar 1 to Apr 30, 2022 | Immunocompromising conditions/immune-suppressive therapy S: 6,525 (41.7%) No mAb: 379,002 (25.0%) Documented COVID-19 vaccine S: 3177 (20.3%) No mAb: 229,770 (15.2%) |
Evans et al., 2023 [33] (preprint at time of search; now peer-reviewed) | UK (Wales) | Observational comparative effectiveness cohort study All-cause hospitalization or death | Cox regression analyses | Secure Anonymised Information Linkage (SAIL) databank | Dec 16, 2021 to Apr 22, 2022 | NR | High-risk non-hospitalised adult patients with COVID-19 using the SAIL databank | Sotrovimab (S) Molnupiravir (M) Nirmatrelvir/ritonavir (Nir/Rit) Untreated (U) | Total: 7,103 S: 1,079 M: 359 Nir/Rit: 602 U: 4,973 | NR | Immunosuppressed: Treated: 968 (47.5%) Untreated: 2,042 (41.1%) ≥ 4 vaccine doses: Treated: 740 (36.3%) Untreated: 875 (17.6%) |
Fujimoto et al., 2022 [27] (peer-reviewed) | Japan (Kishi-wada) | Observational comparative effectiveness cohort study Mortality and requirement for ICU or oxygen therapy | Descriptive analysis for clinical outcomes | Kishiwada City Hospital | July 24, 2021 to Aug 10, 2022 | BA.5: 100% during BA.5 period (July 1 to Aug 10, 2022) | COVID-19 patients hospitalized during delta and omicron subvariants BA.1 and BA.5 periods, treated with sotrovimab, casirivimab/imdevimab or remdesivir and dexamethasone with or without baricitinib | Sotrovimab (S) Casirivimab/imdevimab (Cas/Imd) Remdesivir (R) Dexamethasone ± baricitinib (double or triple therapy) | 179 | BA.5 76 (total) S: 47 Triple Rx: 17 Double Rx: 12 (Ecological) July 1 to Aug 10, 2022 | 40 vaccinated and 2 unvaccinated patients received sotrovimab |
Harman et al., 2022 [34] (preprint at time of search; now peer-reviewed) | UK (England) | Observational comparative cohort study All-cause hospital admission | Stratified Cox regression | UKHSA | Jan 1, 2022 to Apr 26, 2022 | Variant confirmed by laboratory data | High-risk patients with confirmed SARS‐CoV‐2 Omicron BA.1 and BA.2 treated with sotrovimab in the community | Sotrovimab BA.2 confirmed infected patients vs Sotrovimab BA.1 confirmed infected patients | BA.2: 4565 BA.1: 4285 | BA.2 4,565 | ≥ 14 days after second COVID-19 vaccine dose BA.1: 4136 (96.5%) BA.2: 4432 (97.1%) |
Martin-Blondel, et al., 2023 [28] (peer-reviewed) | France (all) | Observational comparative effectiveness cohort study COVID-19-related hospitalization or death | Descriptive analysis for clinical outcomes Multivariable Cox regression analysis | Ongoing ANRS 0003S CoCoPrev study | Jan 24, 2022 to May 5, 2022 | Confirmed variants with sequencing data | Patients at high-risk for progression with mild-to-moderate BA.1 or BA.2 COVID-19 | Sotrovimab (S) Nirmatrelvir (N) | 255 | BA.2 Total: 92 (Sequence-confirmed) | Immunosuppressive therapy: S: 55 (38%) N: 9 (26%) ≥ 3 doses vaccine: S: 147 (78%) N: 52 (87%) |
Mazzotta et al., 2023 [29] (peer-reviewed) | Italy (Rome) | Observational comparative cohort study Hospitalization due to severe COVID-19 or death from any cause | Descriptive analysis for clinical outcomes | Single center (primary data collection) | Jan 1, 2022 to Apr 26, 2022 | Confirmed variants with sequencing data | Outpatients with sequence confirmed SARS‐CoV‐2 Omicron (BA.1 or BA.2) diagnosis and a mild‐to‐moderate COVID‐19 (AIFA eligibility criteria) | Sotrovimab (S) Molnupiravir (M) Remdesivir® Nirmatrelvir/ritonavir (Nir/Rit) | S: 202 M: 117 R: 118 Nir/Rit: 84 | BA.2 S: 56 M: 18 R: 34 Nir/Rit: 35 (Sequence-confirmed) | Primary/secondary immunodeficiency S: 52 (25.7%) M: 17 (14.5%) R: 18 (15.3%) Nir/Rit: 10 (11.9%) Partly or fully vaccinated S: 182 (91.0%) M: 108 (93.1%) R: 101 (85.6%) Nir/Rit: 78 (92.9%) |
Nose et al., 2022 [32] (peer-reviewed) | Japan (All) | Observational comparative effectiveness cohort study Progressor ratec | Descriptive analysis for clinical outcomes | Ongoing multicentre observational study (interim analysis) | Jan 31, 2022 to Aug 19, 2022 | BA.2: 5.8% (n = 20/346)d during March 28 to June 19, 2022 | Patients infected with SARS‒CoV-2, with risk factors for progression to severe infection, not requiring oxygen therapy at baseline, receiving sotrovimab for the first time | Sotrovimab | 346 (246 in clinical outcomes analysis) | BA.2 20d | Immunosuppressive disease or treatment: Total 22 (6.4%) Number of vaccine doses (n = 162 patients): 1 dose: 9 patients 2 doses 85 patients 3 doses: 68 patients |
Patel et al., 2022 [36] (preprint) | UK (England) | Observational comparative effectiveness cohort study COVID-19-related and all-cause hospitalization; all-cause death | Descriptive analysis for clinical outcomes | Discover-NOW dataset | Dec 1, 2021 to May 31, 2022b | BA.2: 90.1% sequenced cases across England during BA.2 period (Mar 1, 2022 to May 31, 2022) BA.5: 70.6% during BA.5 period (June 1, 2022 to July 31, 2022) | COVID-19 patients treated with sotrovimab, nirmatrelvir/ritonavir or molnupiravir, or patients at highest risk per NHS criteria but who were untreated | Sotrovimab (S) Nirmatrelvir/ritonavir (Nir/Rit) Molnupiravir (M) Remdesivir (R) Untreated (U) | Total period: 5547 S: 696 Nir/Rit:337 M: 470 U: 4044 | BA.2 (total) 2045 S: 415 Nir/Rit:269 M: 59 U:1302 BA.5 (total) 1,095 S: 197 Nir/Rit:228 M: 13 U: 657 (Ecological) March 1 to May 31, 2022 for BA.2; June 1 to July 31, 2022 for BA.5 | Immune deficiencies S: 50 (7.2%) Nir/Rit: 96 (28.5) M: 47 (10.0) U: 1080 (26.7) > 1 booster vaccine S: 238 (34.2%) Nir/Rit: 102 (30.3%) M: 78 (16.6%) U: 553 (13.7%) |
Patel et al., 2023 [35] (preprint) | UK (England) | Observational comparative effectiveness cohort study COVID-19-related hospitalization; all-cause hospitalization or death | Multivariate Poisson regression analyses | Hospital Episode Statistics database | Jan 1, 2022 to July 31, 2022 | BA.2 ≥ 75% during period 3 (Feb 28 to May 1, 2022) BA.5 ≥ 75% during period 6 (July 4 to July 31, 2022) | High-risk patients with COVID-19 presumed treated with sotrovimab in NHS hospitals across England | Sotrovimab | 10,096 | BA.2 ≥ 75% prevalence (Period 3): 3884 BA.5 ≥ 75% prevalence (Period 6): 1383 (Ecological) | Immunosuppressed: Total: 338 (3.3%) |
Rasmussen et al., 2023 [30] (peer-reviewed) | Denmark (all) | Observational comparative effectiveness cohort study Hospitalization or all-cause death | Cox regression Analyses Additional sensitivity analyses | Danish Civil Registration System, Danish National Hospital Registry, Danish Vaccination Registry, National COVID-19 Surveillance System, Danish COVID-19 Genome Consortium | Sept 6, 2021 to July 1, 2022 | 1,573/2,933 (53.6%) | High-risk group individuals treated with sotrovimab following a positive SARS-CoV-2v test in Denmark | Sotrovimab | 2,933 | BA.2 1,573 (Sequence-confirmed) | COVID-19 vaccine status ≤ 1: 267 (9.1%) 2: 309 (10.5%) 3: 1,858 (63.4%) ≥ 4: 499 (17.0%) |
Young-Xu, et al., 2022 [37] (preprint) | US (all) | Observational comparative effectiveness cohort study COVID-19-related hospitalization or all-cause mortality | Exact matching Multivariable Cox regression analyses | US Department of Veterens Affairs healthcare system | Dec 1, 2021 to May 4, 2022 | BA.2 dominant (Mar 16, 2022 to May 4, 2022) | High-risk veterans aged ≥ 18 years, diagnosed with COVID-19 | Sotrovimab (S) Untreated (U) | 148,214 (14,066 after matching) | BA.2 Total: 360 (Ecological) March 16 to May 4, 2022 | Immunosuppressive disease (matched cohort): S: 999 (35%) U: 3,935 (35%) 3 doses of vaccine (matched cohort): S: 957 (34%) U: 3,820 (34%) |
Zaqout et al., 2022 [31] (peer-reviewed) | Qatar (all) | Observational comparative effectiveness cohort study Progression to severe, critical, or fatal COVID-19 | Exact matching (1:2) conditional logistic regression Immuno-compromised subgroup analysis | Resident population of Qatar | Oct 20, 2021 to Feb 28, 2022 | Omicron BA.2: ~ 60.4% 86.3% Omicron-predominant period (with > 70% BA.2 of Omicron cases) | High-risk patients (based on EUA criteria; with no vaccination considered as an additional eligibility criteria) | Sotrovimab (S) No treatment (N) | S: 519 N: 2845 | NR (Ecological) | Two or three vaccine doses S: 366 (70.1%) N: 2187 (76.9%) |
Zheng et al., 2022 [38] (preprint at time of search; now peer-reviewede) | UK (England) | Observational comparative effectiveness cohort study Hospitalization due to COVID-19; death from COVID-19 | Stratified multiple variable Cox regression Propensity score weighting Cox regression analysis Additional sensitivity analyses to assess robustness of main findings | OpenSAFELY platform | Dec 16, 2021 to Feb 10, 2022 Feb 16, 2022 to May 1, 2022 | Omicron BA.2 > 50%a | Outpatients with one of the listed high-risk conditions | Sotrovimab (S) Molnupiravir (M) | Total period BA.1 (period 1): 5951 S: 3288 M: 2663 Total period BA.2 (period 2): 7949 S: 5979 M: 1970 | BA.2 S: 5979 M: 1970 (Ecological) | Immunosuppression S: 578 (17.6%) M: 547 (20.5%) Three or more vaccinations S: 2901 (88.2%) M: 2300 (86.4%) |
Zheng et al., 2023 [39] (preprint) | UK (England) | Observational comparative effectiveness cohort study COVID-19-related hospitalization or death; all-cause hospitalization or death | Multivariable Cox regression analyses Propensity score weighted Cox regression Additional sensitivity analyses | OpenSAFELY platform | Feb 11, 2022 to Oct 1, 2022 | BA.2 dominant (Feb 11 to May 31, 2022) BA.5 dominant (June 1 to October 1, 2022) | High-risk adult outpatients with SARS-CoV-2 | Sotrovimab (S) Nirmatrelvir/ritonavir (Nir/Rit) Molnupiravir (M) | Total 7683 S: 2847 Nir/Rit: 4836 M: 802 (exploratory analysis) | NR | Immunosuppression: S: 290 (10.2%) Nir/Rit: 525 (10.9%) ≥ 4 vaccines: S: 1,258 (44.2%) Nir/Rit: 2,047 (42.3%) |
Variant predominant | Outcome definition | Outcome time point | Sotrovimab (N) | Comparator (N) | Outcome N (%) | Relative effect (95% CI), significance | |
---|---|---|---|---|---|---|---|
Sotrovimab | Comparator | ||||||
Cheng et al., 2023 [26] | |||||||
Overall (Sept 2021 through Apr 2022) | Hospitalization or mortality (all-cause) | 30 days of diagnosis | 15,633 | No mAb (unmatched: 1,514,868; matched: 62,532) | 419 (2.68) | Unmatched: 84,720 (5.59) Matched: NR | RR 0.45 (0.41–0.49), p < 0.0001a PS-matched 0.39 (0.35–0.43), p < 0.0001b |
Mar 2022 through Apr 2022 | Hospitalization or mortality (all-cause) | 30 days of diagnosis | Mar 2022: 1046 Apr 2022: 68 Combined for BA.2: 1,114 | No mAb (unmatched Mar 2022: 65,521; Apr 2022: 117,238; combined for BA.2: 182,759; matched: NR) | Mar 2022: 21 (calculated, 2.01% of 1046) Apr 2022: 1 (calculated, 1.47% of 68) Combined for BA.2: 22 (2.0) | Mar 2022: 2,863 (calculated, 4.37% of 65,521) Apr 2022: 2,228 (calculated, 1.90% of 117,238) Combined for BA.2: 5,091 (2.8) Matched: NR | Mar 2022 RR 0.41 (0.27–0.62), p < 0.0001a March 2022 PS-matched 0.36 (0.23–0.56), p < 0.0001b Apr 2022 RR 0.54 (0.08–3.54), p = 0.52a Apr 2022 PS-Matched 0.32 (0.04–2.38), p = 0.52b |
Evans et al., 2023 [33] | |||||||
BA.1 and BA.2 | All-cause hospitalization or death | 28 days of treatment | 1,079 | Molnupiravir (M) (359) Nirmatrelvir/Ritonavir (Nir/Rit) (602) Untreated (U) (4973) | 53 (4.9) | M: 14 (3.9) Nir/Rit: 17 (2.8) U: 544 (10.9) | S: Adjusted HR 0.73 (0.55–0.98) M: Adjusted HR 0.49 (0.29–0.83) Nir/Rit: Adjusted HR 0.59 (0.36–0.97) U: Reference group |
Fujimoto et al., 2022 [27] | |||||||
BA.5 | Mortality | During BA.5 wave | 47 | Remdesivir/dexamethasone (Rem/Dex) (12) | 1 (2.1) | Rem/Dex: 1 (8.3) | NR |
BA.5 | Required oxygen therapy on first and third day of treatment | First and third day of treatment | 47 | NR | 2 (4.3) | NR | NR |
Harman et al., 2023 [34] | |||||||
BA.2 vs BA.1 | Hospitalization or mortality (all-cause) | 14 days of treatment | BA.2 (4565) BA.1 (4285) | – | BA.2: 77 (1.7) BA.1: 91 (2.1) | – | BA.2 vs BA.1 HR 1.17 (0.74–1.86), p = NRc |
BA.2 vs BA.1 | Hospitalization or mortality (COVID-19-related) | 14 days of treatment | BA.2 (4565) BA.1 (4285) | BA.2: 62 (1.4) BA.1: 73 (1.7) | BA.2 vs BA.1 HR 0.98 (0.58–1.65), p = NRc | ||
Martin-Blondel et al., 2023 [28] | |||||||
BA.1 and BA.2 | COVID-19-related hospitalization | 28 days of treatment | 193 | Nirmatrelvir (Nir) (55) | 4 (2) | Nir: 0 (0) | NR |
BA.1 and BA.2 | COVID-19-related deaths | 28 days of treatment | 193 | Nir (55) | 0 (0) | Nir: 1 (2) | NR |
Mazzotta et al., 2023 [29] | |||||||
BA.1 | Hospitalization (COVID-19-related) or mortality (all-cause) | 30 days of treatment | 146 | Nirmatrelvir/ ritonavir (Nir/Rit) (49) Remdesivir (R) (84) Molnupiravir (M) (99) | 5 Overall BA.1 + BA.2: 7/226 (3.1) | Nir/Rit: 2 Overall BA.1 + BA.2: 2/87 (2.3) R 0 (0) M 0 (0) | NR |
BA.2 | Hospitalization (COVID-19-related) or mortality (all-cause) | 30 days of treatment | 56 | Nir/Rit (35) R (34) M (18) | 2 Overall BA.1 + BA.2: 7/226 (3.1) | Nir/Rit: 0 Overall BA.1 + BA.2: 0/87 R 0 (0) M 0 (0) | NR |
Nose et al., 2022 [32] | |||||||
BA.1 | Progression | 29 days of treatment | 118 | NR | 1 (0.8) | NR | (0.02–4.63) |
BA.2 | Progression | 29 days of treatment | 128 | NR | 0 (0.0) | NR | (0.00–2.84) |
Patel et al., 2022 [36] | |||||||
BA.1, BA.2 and BA.5 | COVID-19-related hospitalization | 28 days of treatment | 696 | Nirmatrelvir/ritonavir (Nim/Rit) (337) Molnupiravir (M) (470) Untreated (U) (4044) | 5 (0.7) | Nim/Rit: < 5 (0.3–1.2) M: 10 (2.1) U: 114 (2.8) | NR |
BA.1, BA.2 and BA.5 | All-cause hospitalization | 28 days of treatment | 696 | Nirmatrelvir/ritonavir (Nim/Rit) (337) Molnupiravir (M) (470) Untreated (U) (4,044) | 35 (5.0) | Nim/Rit: 5 (1.5) M: 19 (4.0) U: 251 (6.2) | NR |
BA.1, BA.2, BA.5 | Mortality | 28 days of treatment | 696 | Nim/Rit (337) M (470) U (4,044) | 8 (1.1) | Nim/Rit: < 5 (0.3–1.2) M: 7 (1.5) U: 75 (1.9) | NR |
BA.2 | COVID-19-related hospitalization | During period of pre-dominance | 415 | Nim/Rit (269) M (59) U (1,302) | < 5 (0.2–1.0) | Nim/Rit: NR M: < 5 (1.7–6.8) U: 27 (2.1) | NR |
BA.5 | COVID-19-related hospitalization | During period of pre-dominance | 197 | Nim/Rit (228) M (13) U (657) | < 5 (0.5–2.0) | Nim/Rit: 0 (0) M: < 5 (7.7–30.8) U: 12 (1.8) | NR |
Patel et al., 2023 [35] | |||||||
BA.1, BA.2 and BA.5 | COVID-19-related hospitalization | 28 days of treatment | 10,096 | NR | 96 (1.0) | NR | NR |
BA.1, BA.2 and BA.5 | All-cause hospitalization | 28 days of treatment | 10,096 | NR | 465 (4.6) | NR | NR |
BA.1, BA.2 and BA.5 | Mortality | 28 days of treatment | 10,096 | NR | 27 (0.3) | NR | NR |
BA.2 | COVID-19-related hospitalization | 28 days of treatment | 3884 | NR | 37 (1.0) | NR | IRR 0.76 (0.44–1.30), p = 0.31 |
BA.5 | COVID-19-related hospitalization | 28 days of treatment | 1383 | NR | 10 (0.7) | NR | IRR 0.56 (0.26–1.19), p = 0.13 |
Rasmussen et al., 2023 [30] | |||||||
Delta, BA.1 and BA.2 | Hospitalization | 90 days of treatment | 2933 | NR | 813 (27.7) | NR | NR |
Delta, BA.1 and BA.2 | Mortality | 90 days of treatment | 2933 | NR | 156 (5.3) | NR | NR |
2022 (surrogate for Omicron) vs 2021 (surrogate for Delta) | Hospitalization | 90 days of treatment | NR | NR | NR | NR | Adjusted HR 0.86 (0.71–1.04)g |
2022 (surrogate for Omicron) vs 2021 (surrogate for Delta) | Mortality | 90 days of treatment | NR | NR | NR | NR | Adjusted HR 0.64 (0.44–0.95)g |
Young-Xu et al., 2022 [37] | |||||||
BA.2 | COVID-19-related hospitalization, emergency department or urgent care visits | 30 days of treatment | 74 | Untreated (U) (286) | < 10 (4.0) | 31 (10.8) | Adjusted HR 0.29 (0.08–0.98)g |
Zaqout et al., 2022 [31] | |||||||
Delta and Omicron | Progression to severe, critical, or fatal COVID-19 | NR | 345 | No treatment (583) | 4 (1.2) | 3 (0.5) | Adjusted OR 2.67 (0.60–11.91)d |
Delta and Omicron | Progression to severe, critical, or fatal COVID-19 in patients at higher risk of severe COVID-19e | NR | 295 | No treatment (533) | 3 (1.0) | 8 (1.5) | Adjusted OR 0.65 (0.17–2.48)d |
Omicron | Progression to severe, critical, or fatal COVID-19 | NR | 233 | No treatment (431) | 2 (0.9) | 0 (0) | NR |
Omicron | Progression to severe, critical, or fatal COVID-19 in patients at higher risk of severe COVID-19e | NR | 210 | No treatment (391) | 2 (1.0) | 4 (1.0) | 0.88 (0.16–4.89)d |
Zheng et al., 2022i [38] | |||||||
BA.1 | Hospitalization or mortality (COVID-19-related) | 28 days of treatment | 3331 | Molnupiravir (2689) | 32 (0.96) | 55 (2.05) | Stratified Cox HR 0.54 (0.33–0.88), p = 0.014f PSW-Cox HR 0.50 (0.31–0.81), p = 0.005f |
BA.2 | Hospitalization or mortality (COVID-19-related) | 28 days of treatment | 5979 | Molnupiravir (1970) | 57 (0.95) | 40 (2.03) | Stratified Cox HR 0.44 (0.27–0.71), p = 0.001f PSW-Cox HR 0.53 (0.32–0.86), p = 0.010f |
BA.1 | Mortality (COVID-19-related) | 28 days of treatment | 3331 | Molnupiravir (2689) | 7 (0.21) | 18 (0.67) | NR |
BA.2 | Mortality (COVID-19-related) | 28 days of treatment | 5979 | Molnupiravir (1970) | 9 (0.15) | 19 (0.96) | NR |
Zheng et al., 2023 [39] | |||||||
BA.2 and BA.5 | COVID-19-related hospitalization or death | 28 days of treatment | 2847 | Nirmatrelvir/Ritonavir (Nir/Rit) (4,836) | 19 (0.67) | Nir/Rit: 33 (0.68) | Stratified Cox HR 1.14 (0.62–2.08), p = 0.673 h PSW-Cox HR 0.88 (0.45–1.71), p = 0.700 h |
BA.2 and BA.5 | All-cause hospitalization or death | 28 days of treatment | 2847 | Nir/Rit (4,836) | 97 (3.41) | 123 (2.55) | Stratified Cox HR 0.89 (0.67–1.18), p = 0.412 h PSW-Cox HR 0.84 (0.63–1.13), p = 0.248 h |
BA.2 and BA.5 | Mortality | 28 days of treatment | 2847 | Nir/Rit (4,836) | ≤ 5 (≤ 0.18) | 8 (0.17) | NR |