Evidence map›Paper›PMID 39661366›Full record

Observational studyAnnals of medicine2025

Early combination of sotrovimab with nirmatrelvir/ritonavir or remdesivir is associated with low rate of persisting SARS CoV-2 infection in immunocompromised outpatients with mild-to-moderate COVID-19: a prospective single-centre study.

I Gentile, G Viceconte, F Cuccurullo, D Pietroluongo, A D'Agostino, M Silvitelli, S Mercinelli, R Scotto, F Grimaldi, S Palmieri and 4 more

Abstract readObservational Study
In one paragraph

Observational study in Annals of medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

I GentileDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.
G ViceconteDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.ORCID 0000-0003-3989-2520
F CuccurulloDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.
D PietroluongoDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.
A D'AgostinoDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.
M SilvitelliDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.
S MercinelliDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.
R ScottoDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.
F GrimaldiDepartment of Clinical Medicine and Surgery, Hematology Unit, University of Naples "Federico II", Naples, Italy.
S PalmieriHematology Unit, "Antonio Cardarelli" Hospital, Naples, Italy.
A GravettiHematology Unit, "Antonio Cardarelli" Hospital, Naples, Italy.
F TrastulliHematology Unit, "Antonio Cardarelli" Hospital, Naples, Italy.
M MocciaDepartment of Molecular Medicine and Medical Biotechnology, University of Naples "Federico II", Naples, Italy.
A R BuonomoDepartment of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImmunocompromised patients are at high risk of developing persisting/prolonged COVID-19. Data on the early combined use of antivirals and monoclonal antibodies in this population are scarce. RESEARCH DESIGN AND

methodsWe performed an observational, prospective study, enrolling immunocompromised outpatients with mild-to-moderate COVID-19, treated with a combination of sotrovimab plus one antiviral (remdesivir or nirmatrelvir/ritonavir) within 7 days from symptom onset. Primary outcome was hospitalization within 30 days. Secondary outcomes were: needing for oxygen therapy; development of persistent infection; death within 60 days and reinfection or relapse within 90 days.

resultsWe enrolled 52 patients. No patient was hospitalized within 30 days of disease onset, required oxygen administration, died within 60 days, or experienced a reinfection or clinical relapse within 90 days.The clearance rates were 67% and 97% on the 14th day after the end of therapy and at the end of the follow-up period, respectively.Factors associated with longer infection were initiation of therapy 3 days after symptom onset and enrollment for more than 180 days from the beginning of the study. However, only the latter factor was independently associated with a longer SARS-CoV-2 infection, suggesting a loss of efficacy of this strategy with the evolution of SARS-CoV-2 variants.

conclusionsEarly administration of combination therapy with a direct antiviral and sotrovimab seems to be effective in preventing hospitalization, progression to severe COVID-19, and development of prolonged/persisting SARS-CoV-2 infection in immunocompromised patients.

Indexed as

Adenosine MonophosphateAlanineAntibodies, Monoclonal, HumanizedAntiviral AgentsCOVID-19 Drug TreatmentDrug Therapy, CombinationImmunocompromised HostRitonavirSARS-CoV-2AdenosineAdultAgedCOVID-19FemaleHospitalizationHumansAdenosineAdenosine MonophosphateAlanineAntibodies, Monoclonal, HumanizedAntiviral AgentsGS-441524LeucinePyrrolidinesremdesivirRitonavirUracilcombinationCOVID-19immunocompromisednirmatrelvirremdesivirsotrovimab

Identifiers

PMID39661366
PMCPMC11636137

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.