Covid-19 living Data

Pharmacologic treatments for covid-19 patients

Bamlanivimab vs Placebo

This comparison will not be updated. Last search date 14 Dec, 2022

Outpatients

Forest plots
(last update: 2023-01-06)

Summary of findings
(last update: 2023-01-10)

Patient or population: COVID-19 patients
Setting: Worldwide
Intervention: Bamlanivimab
Comparison: Placebo

Outcome	Relative effect (95% CI)	Absolute effect (95% CI)¹		Certainty of the Evidence (GRADE)
Clinical improvement D28	RR: 1.11 (0.94 - 1.32)	60 more per 1000 (from 33 fewer to 175 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious despite a multicentre design this is a single study from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Serious due to wide confidence interval consistent with the possibility for benefit and the possibility for no effect/trivial effect
1 trials Gottlieb R, 2021 478 participants		Bamlanivimab 607 per 1,000 (514 - 721)	Placebo 547 per 1,000
Clinical improvement D60	Outcome not yet measured or reported
Hospitalisation or death	RR: 0.46 (0.20 - 1.10)	30 fewer per 1000 (from 44 fewer to 6 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious studies from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Serious due to low number of participants/events
3 trials Chew K, 2021 (1); Chew K, 2021 (2), Chen P, 2020 784 participants		Bamlanivimab 25 per 1,000 (11 - 61)	Placebo 55 per 1,000
WHO progression score (level 7 or above) D28	Outcome not yet measured or reported
WHO progression score (level 7 or above) D60	Outcome not yet measured or reported
All-cause mortality D28	RR: ( - )	Zero events in both groups		Very low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious studies from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious no events in both groups
3 trials Chew K, 2021 (1); Chew K, 2021 (2); Gottlieb R, 2021 795 participants		Bamlanivimab 0 per 1,000 ( - )	Placebo 0 per 1,000
All-cause mortality D60	RR: ( - )	Zero events in both groups		Very low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious studies from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious no events in both groups
3 trials Chew K, 2021 (1); Chew K, 2021(2); Gottlieb R, 2021 795 participants		Bamlanivimab 0 per 1,000 ( - )	Placebo 0 per 1,000
Viral negative conversion D7	RR: 0.91 (0.51 - 1.61)	10 fewer per 1000 (from 54 fewer to 67 more)		Very low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Serious despite a multicentre design this is a single study from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
1 trials Gottlieb R, 2021 444 participants		Bamlanivimab 100 per 1,000 (56 - 178)	Placebo 110 per 1,000
Adverse events	RR: 1.20 (0.82 - 1.76)	51 more per 1000 (from 46 fewer to 193 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Serious Inconsistency downgraded by 1 level: I²=:57.4% Indirectness: Not serious We presume that the adverse event rates and the corresponding relative risks, are similar across diverse settings, therefore not downgraded for indirectness Imprecision: Serious due to wide confidence interval consistent with the possibility for no effect/trivial effect and the possibility for harm
3 trials Chew K, 2021 (1); Chew K, 2021 (2); Gottlieb R, 2021 795 participants		Bamlanivimab 305 per 1,000 (208 - 447)	Placebo 254 per 1,000
Serious adverse events	RR: 0.90 (0.35 - 2.28)	3 fewer per 1000 (from 18 fewer to 36 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious We presume that the adverse event rates and the corresponding relative risks, are similar across diverse settings, therefore not downgraded for indirectness Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
3 trials Chew K, 2021 (1); Chew K, 2021 (2); Gottlieb R, 2021 795 participants		Bamlanivimab 25 per 1,000 (10 - 64)	Placebo 28 per 1,000

¹The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)

CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Hospitalized patients

Forest plots
(last update: 2022-10-07)

Summary of findings
(last update: 2022-10-13)

Patient or population: COVID-19 patients
Setting: Worldwide
Intervention: Bamlanivimab
Comparison: Placebo

Outcome	Relative effect (95% CI)	Absolute effect (95% CI)¹		Certainty of the Evidence (GRADE)
Clinical improvement D28	RR: 1.11 (0.80 - 1.52)	94 more per 1000 (from 171 fewer to 446 more)		Very low certainty Reasons to downgrade Risk of bias: Serious Risk of bias downgraded by 1 level: high risk regarding missing data Inconsistency: Not serious Indirectness: Serious despite a multicentre design this is a single study from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
1 trials Chen P, 2021 26 participants		Bamlanivimab 951 per 1,000 (686 - 1000)	Placebo 857 per 1,000
Clinical improvement D60	RR: 0.98 (0.90 - 1.07)	17 fewer per 1000 (from 87 fewer to 61 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Multicentre study conducted across several countries, therefore not downgraded for indirectness Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
1 trials Lundgren J, 2021 326 participants		Bamlanivimab 849 per 1,000 (780 - 927)	Placebo 866 per 1,000
WHO progression score (level 7 or above) D28	RR: 1.67 (0.57 - 4.88)	20 more per 1000 (from 13 fewer to 118 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
2 trials Lundgren J, 2021; Chen P, 2021 352 participants		Bamlanivimab 51 per 1,000 (17 - 149)	Placebo 30 per 1,000
WHO progression score (level 7 or above) D60	RR: *	Zero events in both groups		Very low certainty Reasons to downgrade Risk of bias: Serious Risk of bias downgraded by 1 level: high risk regarding missing data Inconsistency: Not serious Indirectness: Serious despite a multicentre design this is a single study from a single country, therefore results in this population might not be generalizable to other settings. Imprecision: Very serious no events in both groups
1 trials Chen P, 2021 26 participants		Bamlanivimab 0 per 1,000 (* - *)	Placebo 0 per 1,000
All-cause mortality D28	RR: 1.39 (0.4 - 4.85)	10 more per 1000 (from 15 fewer to 94 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
2 trials Lundgren J, 2021; Chen P, 2021 352 participants		Bamlanivimab 34 per 1,000 (10 - 118)	Placebo 24 per 1,000
All-cause mortality D60	RR: 1.10 (0.51 - 2.38)	7 more per 1000 (from 33 fewer to 93 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
2 trials Lundgren J, 2021; Chen P, 2021 352 participants		Bamlanivimab 74 per 1,000 (34 - 160)	Placebo 67 per 1,000
Viral negative conversion D7	Outcome not yet measured or reported
Adverse events	RR: 1.11 (0.53 - 2.29)	63 more per 1000 (from 269 fewer to 737 more)		Very low certainty Reasons to downgrade Risk of bias: Serious Risk of bias downgraded by 1 level: high risk regarding missing data Inconsistency: Not serious Indirectness: Not serious We presume that the adverse event rates and the corresponding relative risks, are similar across diverse settings, therefore not downgraded for indirectness Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
1 trials Chen P, 2021 26 participants		Bamlanivimab 634 per 1,000 (303 - 1000)	Placebo 571 per 1,000
Serious adverse events	RR: 0.70 (0.30 - 1.61)	22 fewer per 1000 (from 51 fewer to 45 more)		Low certainty Reasons to downgrade Risk of bias: Not serious Inconsistency: Not serious Indirectness: Not serious Imprecision: Very serious due to very wide confidence interval consistent with the possibility for benefit and the possibility for harm
2 trials Lundgren J, 2021; Chen P, 2021 352 participants		Bamlanivimab 51 per 1,000 (22 - 118)	Placebo 73 per 1,000

¹The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)

CI: Confidence interval; RR: Risk ratio

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Permanent URL for this comparison: https://covid-nma.com/living_data/index.php?comparison=138

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Trial	Funding	Comparisons		Design	Participants	Sample size	Overall risk of bias Highest assessment	Full description
		Treatment 1	Treatment 2
NCT04411628 J2W-MC-PYAA Chen P, Clin Pharmacol Ther, 2021 Full text Commentary	Private	Bamlanivimab	Placebo	RCT	Patients with confirmed COVID-19 (mild-moderate) admitted to 5 centers in the USA	N=26	High Details	Full description
NCT04518410 ACTIV-2/A5401 Chew K, Nat Commun, 2022 b Full text Full text Commentary Commentary	Mixed	Bamlanivimab (LY-CoV555 700 mg)	Placebo	RCT	Outpatients with confirmed COVID-19 (mild) treated at 38 centers in the USA	N=220	Some concerns Details	Full description
NCT04518410 ACTIV-2/A5401 Chew K, Nat Commun, 2022 a Full text Full text Commentary Commentary	Mixed	Bamlanivimab (LY-CoV555) 7000 mg	Placebo	RCT	Outpatients with confirmed COVID-19 (mild) treated at 38 centers in the USA	N=97	Some concerns Details	Full description
NCT04427501 BLAZE-1 Gottlieb R, JAMA, 2021 Full text Commentary Commentary	Private	Bamlanivimab (LY-CoV555 700 mg/2800 mg/7000 mg) Bamlanivimab (LY-CoV555 700 mg/2800 mg/7000 mg) Bamlanivimab+Etesevimab (LY-CoV555+LY-CoV016)	Placebo Bamlanivimab+Etesevimab (LY-CoV555+LY-CoV016) Placebo	RCT	Outpatients with COVID-19 (mild ambulatory) treated at 49 centers in USA	N=592	Some concerns Details	Full description
NCT04501978 ACTIV-3/TICO Lundgren J, J Ann Intern Med, 2021 Full text Full text Full text Commentary Commentary	Mixed	Bamlanivimab (LY-CoV555)	Placebo	RCT	Patients with confirmed COVID-19 (mild-severe) admitted to 31 centers in Denmark, Singapore and USA	N=326	Some concerns Details	Full description
NCT04427501 BLAZE-1 Chen P, N Engl J Med, 2020 Full text Commentary	Private	Bamlanivimab (LY-CoV555)	Placebo	RCT	Outpatients with confirmed COVID-19 (mild) treated at 41 centers in USA	N=467	Low Details	Full description