Table 1 This table shows a comprehensive overview of the included trials

Benotmane et al. 2022 [38] France

Retrospective cohort study, 28, 2021 to March 13, 2022, in France

KTR patients who had previously received the combination of casirivimab-imdevimab may also have been exposed to those who had sub-optimal responses to SARS-CoV2 mRNA vaccinations

Median (IQR)

60.1 (52.3–71.9)

23/39 (59)

I.M Evusheld

Null

150 mg tixagevimab and 150 mg cilgavimab

For SARS-CoV-2 IgG II Quant A testing, a titer of 7.1 BAU/mL (50 arbitrary units/mL) or more significant for anti-RBD IgG antibodies was determined as the positive limit. The results of a 1:40 dilution of sera were considered positive for neutralizing antibodies if they neutralized 50% or more of the SARS-CoV-2 pseudovirus

Kertes et al. 2022 [47] Israel

Retrospective observational study

Age 12 and above, 40 kg or more, no recent positive test results for COVID-19 (PCR or antigen), no recent COVID-19 vaccination, and significant immunosuppression, as defined by the International Medical Organization for Health (IMOH)

12 to 39

40 to 59

60 to 69

70 to 79

80+

4.1

29.9

28.6

30.5

6.8

512 (62.1)

I.M AZD7442

Did not receive AZD7442

300 mg: 150 mg tixagevimab and 150mg 5 cilgavimab

SARS-CoV-2 infection was the primary endpoint of the study, determined by the presence of 14 positive polymerase chain reactions (PCR) or antigen test results over the follow-up period. The trial's secondary endpoint was severe COVID-19 illness, measured in every group during simultaneous periods and determined as COVID-19-related hospitalization and all-cause fatalities

Nguyen et al, 2022 [27] France

An observational multicentre cohort study in nine divisions on three University

Hospitals found in Ile-de-France between December 28, 2021, and March 31, 2022

Patients with impaired immunity who get tixagevimab/cilgavimab as pre-exposure prophylaxis after at least three doses of vaccination had a Reduced response, as measured by anti-spike IgG and antibodies

Mean (SD)

58.9 (20.7)

Not reported

Tixagevimab/cilgavimab as pre-exposure prophylaxis

None

Tixagevimab/cilgavimab 150/150 mg intramuscularly

This study aimed to report the occurrence and outcomes among immunosuppressed patients who received Evusheld as prophylaxis in France. The omicron wave, where positive re-time PCR of SARS CoV-2. confirmed COVID-19 infections

Thomas et al. 2022 [40]

ACTIV-3–(TICO) Study Group

Multicounty

Randomized controlled trial

18-year-old patients with COVID-19 symptoms spent up to 12 days in the hospital

55 (44–66)

1579

Tixagevimab/cilgavimab

Placebo

Tixagevimab 300 mg/cilgavimab 300 mg

The primary outcome was the time to prolonged recovery through day 90. The secondary outcomes included mortality at 90 days and a combined safety result (death, severe adverse events, organ failure, and serious co-infection)

Young et al. 2022 [31]

United States

Retrospective cohort study

Veterans older than eighteen. Patients in the treatment arm got at least one dose of tixagevimab/cilgavimab at some point during the observation period. Those patients who did not get tixagevimab/cilgavimab but were nonetheless considered high-risk were included as controls

Mean (S.D.)

67.4 (11)

1579 (91)

Intramuscular tixagevimab/cilgavimab

Immunocompromised or other high-risk patients who did not receive tixagevimab/cilgavimab

(150 mg/150 mg) then increased to 300 mg /300mg

SARS-CoV-2 infections were approved using the reverse transcriptase polymerase chain reaction (RT-PCR) or antigen testing. A positive SARS-CoV-2 RT-PCR result or antigen test within 30 days of a hospital admission or discharge diagnosis for COVID-19 was considered hospitalized for the virus. A date of death (DoD) during follow-up was deemed all-cause mortality

Levin et al. 2022 [11]

Multicounty (PROVENT)

The parallel-group, randomized, double-blind, multicenter, placebo-controlled trial, The primary analysis data cut-off date was May 5, 2021. The primary objective, significant supporting analyses, and significant secondary endpoints all had an additional prolonged follow-up data deadline on August 29, 2021. The trial is anticipated to end on June 29, 2022

A screening SARS-CoV-2 serologic test result that was negative for all subjects was required. Individuals with a history of COVID infection were excluded, and those who were elderly (60 years or older) and obese were more likely to be immunocompromised, unable to receive the COVID-19 vaccination without experiencing negative side effects, or to have chronic kidney disease, heart problems, chronic obstructive respiratory disease, or chronic liver disease. Also, the study involved participants with an increasing probability of catching SARS-CoV-2

Mean (S.D.)

53.6 (15)

1865 (53.9%)

Evusheld

Placebo

Evusheld

The beginning of symptomatic COVID-19, as determined by confirmed findings from RT-PCR testing and started after the administration of Evusheld or placebo and on or before 183 days, was the primary efficacy endpoint

Lafont et al. 2022 [28] France

A monocentric observational retrospective study on December 20, 2021, and March 15, 2022

15 individuals in the prophylactic group and 13 in the treatment group, including immunocompromised patients older than 18 years with COVID-19-positive PCR or antigen test

Median (IQR)

56 (44–63)

8 (53)

Tixagevimab/cilgavimab

No

300 mg

The death rate was significantly lower in the treated group when patients who received targeted anti-SARS-CoV-2 therapy with no prophylaxis and those who did not were compared. In patients getting treatment, there were no grave adverse effects noted. Six out of fifteen patients who received tixagevimab/cilgavimab as pre-exposure prophylaxis had later curative therapy, and there were no deaths associated with COVID-19

Ordaya et al. 2022 [30]

United States

Descriptive analysis

All patients who received the first allowed dosage of tixagevimab 150 mg co-formulated with cilgavimab 150 mg and were 18 years or older were included in this research

Median (IQR)

57 (28.7–71.5)

2 (25)

Tixagevimab 150 mg co-formulated with cilgavimab 150 mg

No

Tixagevimab 150 mg co-formulated with cilgavimab 150 mg

Patients who acquired COVID-19 after 2 months of Evusheld exposure

Levin et al. 2022 (storm chaser) [42]

United States

Randomized controlled trials (RCT)

Individuals were ≥ 18 years old with possible exposure to an infected covid person with or without symptoms within eight days. Participants should not have had symptoms of COVID-19 within ten days

Mean (S.D.)

46.6 (15.7)

376 (50)

AZD7442

Placebo

300 mg AZD7442

The primary safety outcome was the frequency of adverse events, and the primary efficacy outcome was the occurrence of symptomatic COVID-19 after drug or placebo administration

Montgomery 2022 [39] (TACKLE)

Multicounty

Between January 28, 2021, and July 22, 2021, a randomized, double-blind, controlled study

Eligible participants were persons aged 18 years and older who were not currently hospitalized and whose SARS-CoV-2 infection had been confirmed by a laboratory using RT-PCR (or an antigen test on a respiratory sample taken within the last three days

46·3

213 (47%)

Evusheld

Placebo

600 mg dose, one each of 300 mg tixagevimab and 300 mg cilgavimab)

A combination of severe COVID-19 or death through day 29 served as the primary effectiveness outcomes; pneumonia or hypoxemia were considered indicators of severe COVID-19. Furthermore, respiratory failure protection

Karaba et al. 2022 [46]

The United States

A prospective observational cohort study

61 Solid organ transplant patients who were vaccinated

62.5 (57.7–68.5)

25 (41)

Evusheld

600 mg I.M

The binding antibody and neutralization surrogate were evaluated against Omicron siblings BA.1 and BA.2 variants

Jondreville et.al. 2022 [41] France

Retrospective multicentric study

Allo-HSCT patients who used Evusheld as prophylaxis

Median (IQR)

58 (21–74)

Not reported

Evusheld as prophylaxis

No

300-mg Evusheld (tixagevimab and cilgavimab, A 150 mg each)

The frequency and seriousness of SARS-CoV-2 infections in allo-HSCT recipients who obtained Evusheld for prophylaxis

Davis et al. 2022 [35]

The United States

Retrospectively analyzed medical records from January 2022 to August 2022

People who received Evusheld as prophylaxis and had B cell cancer

Median (IQR)

66 (18–91)

149 (59)

Evusheld as prophylaxis

No

Both 300, 600, and 900 mg dose

There were no fatalities and only a few people with infections needed to be hospitalized

Calabrese et al. 2022 [37]

The United States

Retrospective cohort—deidentified

Patients with BCDT or humoral IEI who received at least one dose of tixagevimab/cilgavimab and were subsequently diagnosed with COVID-19 were included

Median, 64

4 (33.3)

Tixagevimab/cilgavimab prophylaxis

300 mg I.M. 6 patients

600 mg I.M. 6 patients

Eleven persons had a slight illness and recovered at home. One person who was hospitalized required high-flow oxygen. There was no death

Aqeel et al. 2022 [48]

The United States

Retrospective cohort study between December 2021 and June

2022

Twenty-one patients with antibody-associated vasculitis (AAV) received rituximab for remission induction and maintenance. They also received Evusheld at a dose of 600 mg

Mean (S.D.)

66 (15.5)

Not reported

Evusheld prophylaxis

None

600 mg (300 mg tixagevimab-300 mg cilgavimab)

The outcomes included CD19, IgG, and the progress of COVID-19 infections before and after treatment with Evusheld

Totschnig et al. 2022 [33] Austria

The retrospective study

Pre-exposure prophylaxis with TIX/CIL was administered to 37 immunocompromised outpatients, and subsequent infections with SARS-CoV2 were monitored

Mean (S.D.)

59.6 (15.1)

53 (59.5)

Evusheld

Prophylaxis

None

TIX/CIL 150 mg/150 mg '(IM)'

Tracking the recurrence of infections and tracking the development of antibodies

Al Jurdi et al. 2022 [43]

The United States

A retrospective multicenter cohort study

222 (SOTRs) who received Evusheld as prophylaxis

Median (IQR)

65 (55–72)

136 (61.3)

Tixagevimab/cilgavimab prophylaxis

None

150–150 mg dose

300–300 mg dose

Goulenok et al. 2022 [49] France

Retrospective, case series; single center

HIV/AIDS patients with IMIDs (AIDs and systemic vasculitis)

Ten patients with severe immunosuppression were given TGM/CGM (intramuscular) (150–150 mg dose)

Seven individuals with a severe immune deficiency were not given any mAbs

Median (IQR)

52 (19–75)

4 (40)

150–150 mg dose

Two of t the patients who tested positive for SARS-CoV-2 by RT-PCR developed COVID-19 (both were Omicron)

Two-thirds of those exposed to TGM/CGM exhibited symptoms of COVID-19

Two-thirds of those who contracted COVID-19 had mild cases after taking TGM and CGM together

Hospitalization due to COVID-19 was necessary for 2/3 of those infected

Kaminski et al. 2022 [45] France

Retrospective cohort; single center

333 KTRs were equipped with TGM/CGM (I.M.)

97 KTRs were given a placebo

Mean (S.D.)

60 (14.4)

204 (61.2)

Placebo

150–150 mg dose

COVID-19 hospitalization was significantly reduced in the TGM/CGM group, with a significant reduction in ICU admissions. Only one patient in the TGM/CGM group died, whereas two in the placebo group

Debbiny et al. 2022 [34] Israel

Retrospective cohort; multicenter

703

immunocompromised

patients received

TGM/CGM (I.M.)

Mean (S.D.)

66.2 (13.7)

402 (57.2)

150–150 mg dose

The TGM/CGM group had lower SARS coronavirus type 2 RT-PCR positivity than the non-TGM/CGM group. In the COVID-19-linked rate of hospitalizations, its frequency was decreased on the TGM/CGM side than the other side

Ollila et al. 2022 [29]

United States

Retrospective

cohort; single center

25 hematologic

malignancy patients

received TGM/CGM

(I.M.)

Not reported

Not reported

12 hematologic

malignancies patients

received no treatment

150–150 mg dose

SARS coronavirus two reverse transcription polymerase chain reaction positivity: the TGM/CGM group had fewer SARS-CoV-2 positive PCR results (zero vs three, p = 0.007). Only one patient who did not receive any treatment died

Zerbit et al. 2022 [32] France

Prospective cohort; single center

57 individuals with hematologic malignancies were given TGM/CGM (intramuscular) (150–150 mg dose)

Median (IQR)

71 (63–78)

36/57 (63)

No TGM or CGM was given to 236 individuals with hematologic malignancies

150–150 mg dose

Reverse transcription polymerase chain reaction positivity for SARS-CoV-2 was lower in the drug group than in no drug one (5/102 vs. 52/236, p 0.05)

Bertrand et al. 2022 [44] France

Retrospective cohort; single center

412 KTRs patients

Mean (SD)

60.2 (14.2)

254 (61.6)

62 KTRs received CRM/IDM (IV)(600–600 mg dose)and 98 KTRs received.no mAbs

COVID-19 infection rate was decreased in the drug group than in no drug one (28 vs. 56, p 0.001)

Hospitalization due to COVID-19: the proportion of patients hospitalized was decreased in the drug group than in no drug one

Also, patients in the drug group needed fewer ICU admissions

Patients assigned to TGM/CGM had no deaths, but five were CRM/IDM side or no mAbs and died

Cochran et al. 2022 [36]

United States

Retrospective cohort; single center

TGM/CGM (I.M.) was administered to 205 individuals with SOTR; the dosage ranged from 150 to 150 mg (n = 14) and 300 to 300 mg (n = 191)

Not reported

Not reported

Patients who got the lower dosage of TGM/CGM (150–150 mg) had a higher possibility of possible positive covid 19 than those who took the higher dose of TGM/CGM (300–300 mg) (4/14 vs 12/156)

One person in fourteen receiving the lower dosage of TGM/CGM (150/150 mg) was hospitalized because of COVID-19, whereas two people in 156 receiving the higher dose (300/300 mg) were admitted. Deaths from COVID-19 were more common in those receiving the lower dosage of TGM/CGM (150/150 mg) than those receiving the higher dose (300/300 mg)