Effect of semaglutide on COVID-19 and other infections: an analysis from the FLOW randomized clinical trial.

Rayner B, Mahaffey KW, Mann JFE, Pratley RE, Rossing P, Belmar N, Bosch-Traberg H, Jeppesen OK, Tran MC, Chernin G, Tuttle KR

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association1 Aug 2026Cited by 3 (Europe PMC)

PMID41728915PMCIDPMC13518088DOI10.1093/ndt/gfag036PepBankPUB-41728915

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Summary

BackgroundIn the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD). This pre-specified analysis assesses the impact of semaglutide on risks of serious infections and coronavirus disease 2019 (COVID-19) in the FLOW trial.MethodsThe main outcome was a three-component composite [time from randomization to first infection serious adverse event (SAE), first hospitalization due to infection, or all-cause death]. Other outcomes included all infection SAEs, COVID-19 adverse events, COVID-19 SAEs, death due to infection and death concurrent with a COVID-19 SAE.ResultsSemaglutide reduced the risk of the main outcome versus placebo [hazard ratio (HR) (95% confidence interval) 0.79 (0.69-0.89); P = .0002]. This risk reduction was greater in subgroups with baseline hemoglobin A1c >8% [HR 0.63 (0.52-0.76)] versus ≤8% [HR 0.93 (0.79-1.11); Pinteraction = .0027], and urine albumin-to-creatinine ratio (UACR) ≥2000 mg/g [HR 0.53 (0.39-0.72)] versus UACR <100 mg/g [HR 0.90 (0.58-1.39); Pinteraction = .0367]. The semaglutide group had a lower rate of infection SAEs (17.9% versus 21.3%; P = .0070), COVID-19 SAEs (6.7% versus 8.8%; P = .0155), COVID-19 adverse events (20.3% versus 22.9%; P = .0190) and hospitalization due to infection (17.5% versus 20.4%; P = .015).ConclusionsSemaglutide reduced risks of infection SAEs, hospitalization due to infection, and all-cause death with greater benefit among those with poorer glycemic control and greater baseline albuminuria. These findings support potential clinical benefits of semaglutide beyond kidney, CV and metabolic outcomes in high-risk patients with T2D and CKD.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes and chronic kidney disease, semaglutide reduced the risk of the main composite of infection serious adverse event, hospitalization due to infection or all-cause death versus placebo (HR 0.79).
In plain wordsIn adults with type 2 diabetes and kidney disease, semaglutide lowered the risk of serious infections, infection hospital stays or death more than placebo.
Peptide
Semaglutide
Outcome
DecreaseMain composite of infection SAE, infection hospitalization or all-cause death
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
HR
0.79 hazard ratio
main outcome
Source sentences
Summary
Semaglutide reduced the risk of the main outcome versus placebo [hazard ratio (HR) (95% confidence interval) 0.79 (0.69-0.89); P = .0002].
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891501
02HumanRandomized controlled trialEfficacy outcome
In participants with baseline HbA1c above 8%, semaglutide reduced the risk of the main infection outcome versus placebo (HR 0.63).
In plain wordsIn people with higher blood sugar at the start, semaglutide lowered the risk of serious infections or death more than placebo.
Peptide
Semaglutide
Outcome
DecreaseMain outcome in subgroup with baseline HbA1c above 8%
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
HR
0.63 hazard ratio
HbA1c >8%
Source sentences
Summary
baseline hemoglobin A1c >8% [HR 0.63 (0.52-0.76)]
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891502
03HumanRandomized controlled trialEfficacy outcome
In participants with baseline HbA1c of 8% or lower, semaglutide did not significantly change the risk of the main infection outcome versus placebo (HR 0.93).
In plain wordsIn people with lower blood sugar at the start, semaglutide did not clearly change the risk of serious infections or death compared with placebo.
Peptide
Semaglutide
Outcome
No significant changeMain outcome in subgroup with baseline HbA1c 8% or lower
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
HR
0.93 hazard ratio
HbA1c <=8%
Source sentences
Summary
≤8% [HR 0.93 (0.79-1.11); Pinteraction = .0027]
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891503
04HumanRandomized controlled trialEfficacy outcome
In participants with UACR of 2000 mg/g or higher, semaglutide reduced the risk of the main infection outcome versus placebo (HR 0.53).
In plain wordsIn people with a lot of protein in the urine, semaglutide lowered the risk of serious infections or death more than placebo.
Peptide
Semaglutide
Outcome
DecreaseMain outcome in subgroup with UACR 2000 mg/g or higher
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
HR
0.53 hazard ratio
UACR >=2000 mg/g
Source sentences
Summary
urine albumin-to-creatinine ratio (UACR) ≥2000 mg/g [HR 0.53 (0.39-0.72)]
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891504
05HumanRandomized controlled trialEfficacy outcome
In participants with UACR below 100 mg/g, semaglutide did not significantly change the risk of the main infection outcome versus placebo (HR 0.90).
In plain wordsIn people with little protein in the urine, semaglutide did not clearly change the risk of serious infections or death compared with placebo.
Peptide
Semaglutide
Outcome
No significant changeMain outcome in subgroup with UACR below 100 mg/g
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
HR
0.9 hazard ratio
UACR <100 mg/g
Source sentences
Summary
UACR <100 mg/g [HR 0.90 (0.58-1.39); Pinteraction = .0367].
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891505
06HumanRandomized controlled trialEfficacy outcome
The semaglutide group had a lower rate of infection serious adverse events than the placebo group (17.9% versus 21.3%).
In plain wordsFewer people on semaglutide had serious infections than on placebo.
Peptide
Semaglutide
Outcome
DecreaseInfection serious adverse event rate
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
rate
17.9%
semaglutide
rate
21.3%
placebo
Source sentences
Summary
lower rate of infection SAEs (17.9% versus 21.3%; P = .0070)
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891506
07HumanRandomized controlled trialEfficacy outcome
The semaglutide group had a lower rate of COVID-19 serious adverse events than the placebo group (6.7% versus 8.8%).
In plain wordsFewer people on semaglutide had serious COVID-19 events than on placebo.
Peptide
Semaglutide
Outcome
DecreaseCOVID-19 serious adverse event rate
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
rate
6.7%
semaglutide
rate
8.8%
placebo
Source sentences
Summary
COVID-19 SAEs (6.7% versus 8.8%; P = .0155)
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891507
08HumanRandomized controlled trialEfficacy outcome
The semaglutide group had a lower rate of COVID-19 adverse events than the placebo group (20.3% versus 22.9%).
In plain wordsFewer people on semaglutide had COVID-19 adverse events than on placebo.
Peptide
Semaglutide
Outcome
DecreaseCOVID-19 adverse event rate
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
rate
20.3%
semaglutide
rate
22.9%
placebo
Source sentences
Summary
COVID-19 adverse events (20.3% versus 22.9%; P = .0190)
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891508
09HumanRandomized controlled trialEfficacy outcome
The semaglutide group had a lower rate of hospitalization due to infection than the placebo group (17.5% versus 20.4%).
In plain wordsFewer people on semaglutide were hospitalized for infection than on placebo.
Peptide
Semaglutide
Outcome
DecreaseHospitalization due to infection
Study
n: not reported in source
Comparator
Placebo
Outcome group
Infection and antimicrobial activity · Infection
Studied dose
1.0 mg once weekly · subcutaneousAs given in this study (human).
Measurements
rate
17.5%
semaglutide
rate
20.4%
placebo
Source sentences
Summary
hospitalization due to infection (17.5% versus 20.4%; P = .015)
1 context sentence(design, population, supporting numbers)
Summary · context
In the FLOW trial (Evaluate Renal Function with Semaglutide Once-Weekly; ClinicalTrials.gov, NCT03819153), once-weekly subcutaneous semaglutide 1.0 mg versus placebo reduced the risk of major kidney, cardiovascular (CV) and mortality outcomes in participants with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Show in the study text Report a problemFND-4172891509

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03819153

A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease

Novo Nordisk A/Sn = 3,53317 Jun 2019 to 9 Jan 2024

Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 20 Mar 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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