Trial reportInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2023
Lopinavir/ritonavir for treatment of non-hospitalized patients with COVID-19: a randomized clinical trial.
Trial report in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04372628 (Trial of Early Therapies During Non-hospitalized Outpatient Window), which is not on this map. Cited by 15 papers, 4 of them syntheses 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.
Trial of Early Therapies During Non-hospitalized Outpatient Window (TREAT NOW) for COVID-19
Who cites it
15 citing papers in PubMed, 4 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Drug treatments for mild or moderate covid-19: systematic review and network meta-analysis.BMJ (Clinical research ed.) · 2025Pooled it
- A Systematic Review and Meta-Analysis of Low Dose Radiation Therapy for COVID-19 Pneumonia: Learnings of 4 Years Since Pandemic.Clinical and translational science · 2025Pooled it
- The relationship between viral clearance rates and disease progression in early symptomatic COVID-19: a systematic review and meta-regression analysis.The Journal of antimicrobial chemotherapy · 2024Pooled it
- Outpatient randomized controlled trials to reduce COVID-19 hospitalization: Systematic review and meta-analysis.Journal of medical virology · 2023Pooled it
- Trial characteristics, methods and reported challenges of decentralised clinical trials: a scoping review.BMJ open · 2025Article
- Participant experiences in a decentralized clinical trial using digital health technologies: The ACTIV-6 study.Journal of clinical and translational science · 2025Article
- Antivirals in COVID-19: A Focus on Pediatric Cardiac Patients.The Canadian journal of infectious diseases & medical microbiology = Journal canadien des maladies infectieuses et de la microbiologie medicale · 2025Review
- An automated platform trial framework for A/B testing.Contemporary clinical trials communications · 2024Article
- New Therapies and Strategies to Curb HIV Infections with a Focus on Macrophages and Reservoirs.Viruses · 2024Review
- A Gaussia luciferase reporter assay for the evaluation of coronavirus Nsp5/3CLpro activity.Scientific reports · 2024Article
- COVID-19 therapeutics.Clinical microbiology reviews · 2024Review
- Upstrapping to determine futility: predicting future outcomes nonparametrically from past data.Trials · 2024Article
- A practical guide to adopting Bayesian analyses in clinical research.Journal of clinical and translational science · 2024Article
- Remote and semi-automated methods to conduct a decentralized randomized clinical trial.Journal of clinical and translational science · 2023Article
- Examining efficacy and safety of ethyl acetate extract fromAvicenna journal of phytomedicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors at 9 institutions in 1 country.
Funding
Abstract
objectivesEffective and widely available therapies are still needed for outpatients with COVID-19. We aimed to evaluate the efficacy and safety of lopinavir/ritonavir (LPV/r) for early treatment of non-hospitalized individuals diagnosed with COVID-19.
methodsThis randomized, placebo (Plb)-controlled, double-blind, multi-site decentralized clinical trial enrolled non-hospitalized adults with confirmed SARS-CoV-2 infection and six or fewer days of acute respiratory infection symptoms who were randomized to either twice-daily oral LPV/r (400 mg/100 mg) or Plb for 14 days. Daily surveys on study days 1 through 16 and again on study day 28 evaluated symptoms, daily activities, and hospitalization status. The primary outcome was longitudinal change in an ordinal scale based on a combination of symptoms, activity, and hospitalization status through day 15 and was analyzed by use of a Bayesian longitudinal proportional odds logistic regression model for estimating the probability of a superior recovery for LPV/r over Plb (odds ratio >1).
resultsBetween June 2020 and December 2021, 448 participants were randomized to receive either LPV/r (n = 216) or Plb (n = 221). The mean symptom duration before randomization was 4.3 days (SD 1.3). There were no differences between treatment groups through the first 15 days for the ordinal primary outcome (odds ratio 0.96; 95% credible interval: 0.66 to 1.41). There were 3.2% (n = 7) of LPV/r and 2.7% (n = 6) of Plb participants hospitalized by day 28. Serious adverse events did not differ between groups.
conclusionLPV/r did not significantly improve symptom resolution or reduce hospitalization in non-hospitalized participants with COVID-19.
trial registrationClinicalTrials.gov Identifier: NCT04372628.
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Identifiers
What OpenQuestion holds
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.