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. 2022 Oct 12;32(6):e2402. doi: 10.1002/rmv.2402

Efficacy and safety of sotrovimab in patients with COVID‐19: A rapid review and meta‐analysis

Bahman Amani 1, Behnam Amani 1,✉
PMCID: PMC9874927  PMID: 36226323

Abstract

The therapeutic potential of sotrovimab in the treatment of coronavirus disease 2019 (COVID‐19) is a controversial issue. The aim of this study was to evaluate the efficacy and safety of sotrovimab in COVID‐19 patients. To this end, PubMed, Cochrane Library, Embase, Web of Science, medRxiv, and Google Scholar were searched up to 15 August 2022. The reference lists of key studies were also scanned to find additional records. Meta‐analysis was performed using Comprehensive Meta‐Analysis. Seventeen studies involving 27,429 patients were included. A significant difference was observed in mortality rate (odds ratio [OR] = 0.40; 95% CI: 0.25–0.63, p = 0.00), hospitalisation rate (OR = 0.53; 95% CI: 0.43–0.65. p = 0.00), hospital or death rate (OR = 0.43; 95% CI: 0.25–0.73, p = 0.00), the need for mechanical ventilation (OR = 0.57; 95% CI: 0.33–0.96, p = 0.03), and ICU admission (OR = 0.33; 95% CI: 0.17–0.67, p = 0.00) of the sotrovimab‐receiving group compared to those having no sotrovimab. However, no significant difference was observed between the two groups in terms of disease progression (OR = 0.45; 95% CI: 0.16–1.24, p = 0.12) and emergency department visit (OR = 1.01; 95% CI: 0.83–1.24, p = 0.87). The two groups had no significant difference in terms of incidence of adverse events (OR = 0.98; 95% CI: 0.78–1.23, p = 0.88). The findings of the present meta‐analysis support that sotrovimab could be an effective and safe treatment option to reduce mortality and hospitalisation rate in both Delta and Omicron Variants of COVID‐19.

Keywords: COVID‐19, SARS‐CoV‐2, sotrovimab

Abbreviations

CI

confidence interval

COVID‐19

Coronavirus disease 2019

ED

emergency department

EU

European Union

FDA

food and drug administration

mAb

monoclonal antibody

MHRA

medicines and healthcare products regulatory agency

NOS

newcastle–ottawa scale

PCR

polymerase chain reaction

RCT

randomized clinical trial

RR

risk ratio

SARS‐CoV‐2

severe acute respiratory syndrome coronavirus‐2

1. INTRODUCTION

Since the beginning of the coronavirus disease 2019 (COVID‐19) pandemic, many therapeutic interventions have been introduced and evaluated. 1 , 2 , 3 The current evidence shows the effectiveness of monoclonal antibody (mAb) therapy in the prevention and treatment of COVID‐19. 4 Several anti‐severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2) mAb therapies, such as casirivimab/imdevimab, 5 , 6 , 7 bamlanivimab, 8 bamlanivimab/etesevimab, 9 , 10 , 11 and sotrovimab 4 , 12 have been proposed as promising potential treatments for patients with COVID‐19. Their antiviral activities have been shown by binding and neutralising SARS‐CoV‐2. 13 Sotrovimab is a recombinant human mAb developed by Vir Biotechnology and GlaxoSmithKline 14 which is approved by the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of high‐risk patients with mild to moderate COVID‐19 symptoms. 15 On June 2021, the US Food and Drug Administration (FDA) authorised the administration of sotrovimab (a 500‐mg single dose intravenously) in high‐risk patients with COVID‐19. 16 On December 2021, the European Union (EU) granted the use of sotrovimab based on the result of the COMET‐ICE phase III trial. 17 Recently, WHO recommended the use of sotrovimab in patients with non‐severe COVID‐19. 18 Despite several published clinical and observational studies 12 , 19 , 20 showing the therapeutic potential of sotrovimab for COVID‐19 in reducing hospitalisation and mortality rate, there are some controversies over using sotrovimab for COVID‐19 patients. 21 Therefore, the aim of this study is to evaluate the efficacy and safety of sotrovimab in COVID‐19 patients.

2. METHODS

The Preferred Reporting Items for Systematic reviews and Meta‐Analysis—Rapid Review (PRISMA‐RR) was used in this research. 22

2.1. Search strategy

Two researchers independently searched PubMed, Cochrane Library, Embase, Web of Science, medRxiv, and Google Scholar to identify the relevant evidence up to 15 August 2022. The reference lists of key studies and relevant systematic reviews were also scanned to discover additional citations. No language restriction was considered. The search terms key included 2019‐novel coronavirus, SARS‐CoV‐2, COVID‐19, 2019‐nCoV, Sotrovimab, and monoclonal antibody. The following search strategy was used to identify the relevant evidence in PubMed: ((((((((Coronavirus[Title/Abstract]) OR (Coronavirus[MeSH Terms])) OR (COVID‐19[Title/Abstract])) OR (SARS‐CoV‐2[Title/Abstract])) OR (COVID‐19[MeSH Terms])) OR (SARS‐CoV‐2[MeSH Terms])) OR (2019 novel coronavirus infection[Title/Abstract])) OR (2019‐nCoV infection[Title/Abstract])) AND ((Sotrovimab [Title/Abstract]) OR (monoclonal antibody [MeSH Terms]).

2.2. Study selection

The inclusion criteria were as follows: (1) population: patients with positive COVID‐19 polymerase chain reaction (PCR) test, (2) intervention: sotrovimab, (3) control: any therapeutic intervention, and (4) outcomes: primary efficacy outcomes (mortality rate, hospitalisation rate, and hospitalisation or death rate), secondary efficacy outcomes (ICU admission, disease progression, need for mechanical ventilation and emergency department (ED) visits), and safety outcomes (the incidence of adverse events). Studies conducted on animal models, case reports, case series, and commentary were excluded.

2.3. Data extraction and quality assessment

The risk of bias in nonrandomised studies of interventions (ROBINS‐I) 23 and Cochrane RoB 24 tools were used to assess the RoB of observational and randomized controlled trials, respectively. Two researchers independently extracted the following data: (1) information of the study (first author, year of publication, country, and design), (2) patient characteristics (sample size, sex, and mean age), (3) interventions (sample size, treatment dose, and treatment duration), and (4) efficacy and safety outcomes.

2.4. Evidence synthesis

The Comprehensive Meta‐Analysis software (version 3) was used to compare the efficacy and safety of sotrovimab versus control. The odds ratio with a 95% confidence interval (CI) was considered to analyse the dichotomous variables. The heterogeneity was defined as p < 0.10 or I 2>50%. The random‐effects model was used for highly heterogeneous studies. Otherwise, the fixed‐effects model was applied.

3. RESULTS

3.1. Study characteristics

Figure 1 shows the flow diagram of study selection according to its title, abstract, and full text. After removing duplicated records, seventeen studies, 19 , 20 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 (two RCTs and fifteen observational studies) with 27,429 patients were included in the meta‐analysis. The main characteristics of included studies are listed in Table 1.

FIGURE 1.

FIGURE 1

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PRISMA flow diagram of the included studies in the meta‐analysis

TABLE 1.

Characteristics of included studies

First author, year Place Design COVID‐19 variant N (M/F) Intervention (N) Control (N)
Gupta, 2022 29 International a RCT NA 1057 (485/572) Sotrovimab (528) Placebo (529)
Self, 2022 20 International b RCT NA 536 (308/228) Sotrovimab (182) Placebo (178); BRII‐196 plus BRII‐198 group (176)
Aggarwal, 2022 25 USA OS Delta 2085 (912/1173) Sotrovimab (522) mAb‐untreated (1563)
Aggarwal 2022 26 USA OS Omicron 5205 (2058/3147) Sotrovimab (1542) Untreated (3663)
Huang, 2022 31 USA OS Delta 2357 Sotrovimab (311) No treatment (2046)
Ong, 2022 19 Singapore OS NA 94 (59/35) Sotrovimab (19) Untreated 75
Sharif‐Askari, 2022 35 UAM OS NA 10,882 (5492/5390) Sotrovimab (2653) Favipiravir (7094), sotrovimab/favipravir (2653)
Gleeson 2022 28 UK OS Omicron 122 Sotrovimab (47) No treatment (48), Molnupiravir (21), unknown (5), Molnupiravir + sotrovimab (1)
Vora 2022 37 USA OS Omicron 66 Sotrovimab (16) Nirmatrelvir/Ritonavir (12), remdesivir (38)
Zheng, 2022 39 UK OS Omicron 5951 (2451/3500) Sotrovimab (3288) Molnupiravir (2663)
Yetmar, 2022 38 USA OS Omicron 361 (229/139) Sotrovimab (269) Bebtelovimab (92)
Radcliffe 2022 34 USA OS Omicron 122 (70/52) Sotrovimab (24) No therapy (48), Molnupiravir (49), Nirmatrelvir/Ritonavir (1)
Piccicacco 2022 33 USA OS Omicron 260 (127/133) Sotrovimab (88) Control (90), remdesivir (82)
Solera 2022 36 Canada OS Omicron 300 (171/129) Sotrovimab (109) No sotrovimab (191)
Hedvat 2022 30 USA OS Omicron 154 Sotrovimab (51) No treatment (75), Nirmatrelvir/ritonavir (28)
Martin‐Blondel 2022 32 France OS Omicron, Delta 249 Sotrovimab (116) Casirivimab/Imdevimab (133)
Chavarot 2022 27 France OS Omicron 125 (75/50) Sotrovimab (25) No sotrovimab (100)
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Abbreviations: F, female; M, male; N, number; NOS, Newcastle Ottawa Scale; OS, observational study; RCT, randomized controlled trial; RoB, Risk of bias.

a

Brazil; Canada, Peru, Spain, and USA.

b

USA, Denmark, Switzerland, and Poland.

3.2. Risk of bias assessment

The methodological quality of included RCTs was high (Figure 2). The observational studies demonstrated acceptable quality using the ROBINS‐I tool (Table S1).

FIGURE 2.

FIGURE 2

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Risk of bias assessment of the included trials

3.3. Efficacy outcomes

3.3.1. Primary outcomes

The results of the meta‐analysis showed a significant difference between the sotrovimab and no sotrovimab groups in terms of mortality rate (OR = 0.40; 95% CI: 0.25–0.63, p = 0.00, fixed‐effects model), hospitalisation rate (OR = 0.53; 95% CI: 0.43–0.65. p = 0.00, random‐effects model), and hospital or death rate (OR = 0.43; 95% CI: 0.25–0.73, p = 0.00, random‐effects model) (Figure 3).

FIGURE 3.

FIGURE 3

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Forest plot of sotrovimab versus control for primary efficacy outcomes. (a) mortality rate. (b) hospitalisation rate. (c) Hospitalisation or death rate.

3.3.2. Secondary outcomes

Based on the findings of the meta‐analysis, sotrovimab and control groups showed no significant difference in terms of disease progression (OR = 0.45; 95% CI: 0.16–1.24, p = 0.12, random‐effects model), and ED visits (OR = 1.01; 95% CI: 0.83–1.24, p = 0.87, fixed‐effects model) (Figure 4). However, a significant difference was detected between the two groups in terms of need for mechanical ventilation (OR = 0.57; 95% CI: 0.33–0.96, p = 0.03, fixed‐effects model) and ICU admission (OR = 0.33; 95% CI: 0.17–0.67, p = 0.00, fixed‐effects model) (Figure 4).

FIGURE 4.

FIGURE 4

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Forest plot of sotrovimab versus control for secondary efficacy outcomes. (a) ICU admission (b) mechanical ventilation (c) disease progression (d) ED visits.

3.3.3. Safety outcomes

The pooled estimate indicated no significant difference between the sotrovimab and control groups in terms of incidence of adverse events (OR = 0.98; 95% CI: 0.78–1.23, p = 0.88, fixed‐effects model) (Figure 5).

FIGURE 5.

FIGURE 5

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Forest plot of sotrovimab versus control for incidence of adverse events

3.4. Sensitivity analysis and subgroup analysis

A subgroup analysis was carried out based on the dominant variant of SARS‐CoV‐2 and study design for outcomes of mortality and hospitalisation rate (Table 2). The results showed a significant difference between the sotrovimab and control groups in terms of mortality rate based on Delta variant (OR = 0.07; 95% CI: 0.01–0.51, p = 0.00, fixed‐effects model) and Omicron variant (OR = 0.27; 95% CI: 0.14–0.53, p = 0.00, fixed‐effects model). Although the mortality rate was statistically significant for observational studies (OR = 0.24; 95% CI: 0.14–0.43, p = 0.00, fixed‐effects model), but was not significant for RCTs (OR = 0.95; 95% CI: 0.44–2.03, p = 0.90, fixed‐effects model). Moreover, the hospitalisation rate was statistically significant based on COVID‐19 variants and study design (p < 0.05).

TABLE 2.

Subgroup analysis and sensitivity analysis

Analysis No. of studies Sample size Point estimate (95% CI) p‐value Heterogeneity
Q‐value p‐value I‐squared
Sensitive analysis
Mortality rate 15 26,588 0.40 [0.25, 0.63] 0.00 12.15 0.59 00.00
Hospitalisation rate 13 20,315 0.48 [0.34, 0.67] 0.00 23.85 0.02 49.69
Hospitalisation or death rate 4 9491 0.40 [0.22, 0.72] 0.00 8.81 0.03 65.95
Disease progression 5 9930 0.45 [0.16, 1.24] 0.12 11.01 0.02 63.68
ICU admission 6 7488 0.33 [0.17, 0.67] 0.00 2.48 0.77 0.00
ED visits 5 7606 1.00 [0.69, 1.45] 0.96 6.40 0.17 37.51
The need for mechanical ventilation 6 4014 0.39 [0.16, 0.91] 0.03 7.51 0.18 33.43
Adverse events 5 5211 0.98 [0.78, 1.23] 0.88 2.15 0.70 0.00
Subgroup analysis
Mortality rate by COVID‐19 variant
Delta 2 4442 0.07 [0.01, 0.51] 0.00 0.08 0.76 00.00
Omicron 9 12,406 0.27 [0.14, 0.51] 0.00 1.52 0.99 00.00
Mortality rate by study design
RCT 2 1417 0.95 [0.44, 2.03] 0.90 1.08 0.29 7.77
Observational 13 25,171 0.24 [0.14, 0.43] 0.00 3.35 0.99 0.00
Hospitalisation rate by COVID‐19 variant
Delta 2 4442 0.07 [0.01, 0.51] 0.00 0.08 0.76 00.00
Omicron 9 12,406 0.27 [0.14, 0.51] 0.00 1.52 0.99 00.00
Hospitalisation rate by study design
RCT 1 1057 0.19 [0.08, 0.48] 0.00 0.00 1.00 0.00
Observational 11 19,133 0.57 [0.46, 0.71] 0.00 18.12 0.05 44.83
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Abbreviations: CI, confidence interval; ED, emergency department; RCT, randomized controlled trial.

Furthermore, a sensitivity analysis was performed to compare the fixed and random effects estimates of the pooled estimate. A random‐effects model was used for all outcomes regardless of their I2 and p values which showed no change in the pooled estimate for efficacy and safety outcomes including, mortality rate (OR = 0.40; 95% CI: 0.25–0.63, p = 0.00, random‐effects model), hospitalisation rate (OR = 0.48; 95% CI: 0. 34–0. 67, p = 0.00, random‐effects model), hospitalisation or death rate (OR = 0.40; 95% CI: 0.22–0.72, p = 0.00, random‐effects model), disease progression (OR = 0.45; 95% CI: 0.16–1.24, p = 0.12, random‐effects model), ICU admission (OR = 0.33; 95% CI: 0.17–0.67, p = 0.00, random‐effects model), ED visits (OR = 1.00; 95% CI: 0.69–1.45, p = 0.96, random‐effects model), need for mechanical ventilation (OR = 0.39; 95% CI: 0.16–0.91, p = 0.03, random‐effects model), and adverse events (OR = 0.98; 95% CI: 0.78–1.23, p = 0.88, random‐effects model).

3.5. Publication bias

No publication bias was found in pooled estimate of hospitalisation rate (Begg test, p = 0.44; Egger test, p = 0.24). However, publication bias was detected based on Egger's test in pooled estimate of mortality rate (p = 0.001), but the Begg test showed no evidence of publication bias for pooled estimate of mortality rate (p = 0.36).

4. DISCUSSION

The purpose of this study was to examine the efficacy and safety of sotrovimab in the treatment of COVID‐19 infection. Sotrovimab is mainly used to treat patients with mild to moderate COVID‐19 symptoms and prevent the disease progression. 40 However, its efficacy against Omicron variants is unknown. 31

Our result indicated that sotrovimab was associated with a significantly lower mortality rate in patients with COVID‐19 compared with no sotrovimab. In line with our findings, a recent systematic review and meta‐analysis 41 found that neutralising mABs were associated with a significantly lower rate of death in nonhospitalised patients with COVID‐19. However, the meta‐analysis conducted by Ao et al. 42 reported no significant advantages in the use of sotrovimab for the treatment of patients with COVID‐19 infection in terms of mortality rate. This difference in results may be due to more studies included in our meta‐analysis.

The hospitalisation rate was also significantly lower in the sotrovimab‐receiving patients compared to the control. In agreement with our results, a recently published meta‐analysis 43 showed that sotrovimab may reduce the hospitalisation rate in patients with non‐severe COVID‐19. Overall, mAb therapies can effectively reduce the hospitalisation rate caused by COVID‐19 disease. 7 , 9 , 44 , 45 , 46 , 47 , 48 Moreover, a significantly lower rate of hospitalisation or death was observed among sotrovimab‐receiving patients. Note that this finding should be interpreted with caution due to a high degree of heterogeneity between studies.

Nowadays, the therapeutic potential of sotrovimab in treating COVID‐19 infection caused by the Omicron variant is disputed. 49 Recently, FDA suspended the approval of sotrovimab for the treatment of COVID‐19 patients due to the rise in the proportion of BA.2 sub‐variant. 49 Huygens et al. 21 reported sotrovimab resistance and viral persistence in immunocompromised patients with the Omicron variant of SARS‐CoV‐2. Furthermore, current data show the persistence of SARS‐CoV‐2 and spike gene mutations after sotrovimab infusion. 50 However, recent studies 51 , 52 have shown that sotrovimab retains its activity against the Omicron BA.1 variant. Based on VanBlargan et al. 52 unlike other mAbs, neutralising activity of sotrovimab against the Omicron BA.1 variant was minimally affected. 52 Moreover, Mader et al. found that sotrovimab retains its potential in prophylaxis and treatment of the Omicron variant. 51 Our subgroup analysis showed that sotrovimab was effective for patients infected with the SARS‐CoV‐2 Omicron variant in terms of reducing mortality and hospitalisation rate compared to those receiving no sotrovimab.

Our meta‐analysis showed no significant benefit in favour of sotrovimab for secondary outcomes including, disease progression, need for ventilation, and ED visits. In accordance with our results, a meta‐analysis of three studies showed no significant clinical benefits in using sotrovimab in patients with COVID‐19 in terms of disease progression. 42 However, other mAbs were associated with lower risk of disease progression, 6 and ED visits. 41

Based on the present meta‐analysis, sotrovimab treatment was associated with a reduced risk of ICU admission compared with the control. Studies revealed less frequent need for mechanical ventilation 48 and ICU 53 admission among patients treated with anti–SARS‐CoV‐2 mAbs compared with those receiving no mAbs.

According to the findings of our meta‐analysis, treatment with sotrovimab was not associated with higher adverse events compared with those receiving no sotrovimab. The meta‐analysis of Lin et al. 41 showed that neutralising mABs are safe and not associated with a higher risk of adverse events compared to placebo. Anti‐SARS‐CoV‐2 mABs therapies are generally well‐tolerated in patients suffering from COVID‐19. 47 , 54 , 55 , 56 , 57

Our study has some important limitations. First, a significant publication bias was detected in the present meta‐analysis. Second, most studies included in the meta‐analysis are retrospective and subject to sources of bias or confounding. Third, distinct types of pharmaceutical interventions were used as comparison in the present meta‐analysis which can prone the results to imprecision, heterogeneity, and reported effect size. Fourth, some studies included in our analysis did not report the type of COVID‐19 variant in patients; therefore, they were excluded from sub‐group analysis. Fifth, the COVID‐19 patients showed high heterogeneity in terms of COVID‐19 vaccination, treatment protocols, and commodity diseases. Finally, a limited number of studies reported adverse events in the intervention and control treatment groups.

5. CONCLUSION

The findings of the present meta‐analysis indicated the efficacy of sotrovimab in reducing mortality and hospitalisation rate in patients with mild to moderate COVID‐19 compared with no‐sotrovimab groups. The subgroup analysis also revealed that sotrovimab could effectively reduce mortality and hospitalisation rate in patients infected with Omicron or Delta variants of SARS‐CoV‐2. Compared with the control group, sotrovimab was associated with reduced need for mechanical ventilation and ICU admission and hospitalisation or death rate. The findings of this meta‐analysis also showed the safety of sotrovimab. Nonetheless, it was not effective in terms of prevention of disease progression and reduced ED visits.

AUTHOR CONTRIBUTIONS

Conceptualisation and project administration: Bahman Amani and Behnam Amani. Literature searching: Behnam Amani and Bahman Amani. Data extraction and quality assessment: Bahman Amani and Behnam Amani. Data Analysis: Bahman Amani and Behnam Amani. Writing – original draft: Behnam Amani. Writing – review & editing: Bahman Amani and Behnam Amani.

CONFLICTS OF INTEREST

There is no conflict of interest.

Supporting information

Supporting Information S1

Click here for additional data file. (17.5KB, docx)

Amani B, Amani B. Efficacy and safety of sotrovimab in patients with COVID‐19: a rapid review and meta‐analysis. Rev Med Virol. 2022;32(6):e2402. 10.1002/rmv.2402

DATA AVAILABILITY STATEMENT

Data are available online for the included studies. 19 , 20 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supporting Information S1

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Data Availability Statement

Data are available online for the included studies. 19 , 20 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39

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