Trial reportThe Journal of infectious diseases2021
Baseline Severe Acute Respiratory Syndrome Viral Load Is Associated With Coronavirus Disease 2019 Severity and Clinical Outcomes: Post Hoc Analyses of a Phase 2/3 Trial.
Trial report in The Journal of infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04315298 (An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled 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.
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.
An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.
- SARS-CoV-2 positivity in offspring and timing of mother-to-child transmission: living systematic review and meta-analysis.BMJ (Clinical research ed.) · 2022Pooled it
- Virologic Response and Safety of Ibuzatrelvir, A Novel SARS-CoV-2 Antiviral, in Adults With COVID-19.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025Trial
- SARS-CoV-2 RNA and Nucleocapsid Antigen Are Blood Biomarkers Associated With Severe Disease Outcomes That Improve in Response to Remdesivir.The Journal of infectious diseases · 2024Trial
- Viral and Host Factors Are Associated With Mortality in Hospitalized Patients With COVID-19.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Trial
- Effect of IL-6R blockade on plasma lipids and clinical outcomes among hospitalized patients with COVID-19 infection.Journal of lipid research · 2024Trial
- Antibody therapy reverses biological signatures of COVID-19 progression.Cell reports. Medicine · 2022Trial
- Article
- Expression of SARS-CoV-2 entry receptor ACE2 in human brain and its association with Alzheimer's disease and COVID-19.Molecular psychiatry · 2025Review
- Plasma SARS-CoV-2 nucleocapsid antigen levels are associated with lung infection and tissue-damage biomarkers.Virus research · 2025Article
- Uncovering the Contrasts and Connections in PASC: Viral Load and Cytokine Signatures in Acute COVID-19 versus Post-Acute Sequelae of SARS-CoV-2 (PASC).Biomedicines · 2024Review
- Making Drug Approval Decisions in the Face of Uncertainty: Cumulative Evidence versus Value of Information.Medical decision making : an international journal of the Society for Medical Decision Making · 2024Article
- Association of epidemiological and clinical features with PCR cycle threshold values of SARS-CoV-2 infection: a cross-sectional study.Pathogens and global health · 2023Article
- Article
- Effectiveness of Subcutaneous Casirivimab and Imdevimab in Ambulatory Patients with COVID-19.Infectious diseases and therapy · 2022Article
- Plasma SARS-CoV-2 nucleocapsid antigen levels are associated with progression to severe disease in hospitalized COVID-19.Critical care (London, England) · 2022Observational
- Initial Severe Acute Respiratory Syndrome Coronavirus 2 Viral Load Is Associated With Disease Severity: A Retrospective Cohort Study.Open forum infectious diseases · 2022Article
- Comparing studies of SARS-CoV-2 viral loads requires caution.Journal of medical virology · 2022Article
- Understanding on the possible routes for SARS CoV-2 invasion via ACE2 in the host linked with multiple organs damage.Infection, genetics and evolution : journal of molecular epidemiology and evolutionary genetics in infectious diseases · 2022Review
- Viral load and its relationship with the inflammatory response and clinical outcomes in hospitalization of patients with COVID-19.Frontiers in immunology · 2022Observational
- The REMDACTA trial: do interleukin receptor antagonists provide additional benefit in COVID-19?Intensive care medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 1 institution in 1 country.
Funding
Abstract
backgroundElucidating the relationship between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load and clinical outcomes is critical for understanding coronavirus disease 2019 (COVID-19).
methodsThe SARS-CoV-2 levels were analyzed by quantitative real-time polymerase chain reaction (RT-qPCR) of nasopharyngeal or oropharyngeal swab specimens collected at baseline, and clinical outcomes were recorded over 60 days from 1362 COVID-19 hospitalized patients enrolled in a multicenter, randomized, placebo-controlled phase 2/3 trial of sarilumab for COVID-19 (ClinicalTrials.gov NCT04315298).
resultsIn post hoc analyses, higher baseline viral load, measured by both RT-qPCR cycle threshold and log10 copies/mL, was associated with greater supplemental oxygenation requirements and disease severity at study entry. Higher baseline viral load was associated with higher mortality, lower likelihood of improvement in clinical status and supplemental oxygenation requirements, and lower rates of hospital discharge. Viral load was not impacted by sarilumab treatment over time versus placebo.
conclusionsThese data support viral load as an important determinant of clinical outcomes in hospitalized patients with COVID-19 requiring supplemental oxygen or assisted ventilation.
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Registered trials
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.