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The Adjuvant Efficacy of Angong Niuhuang Pill in the Treatment of Viral Encephalitis: A Meta-Analysis of Randomized Controlled Trials
Published on: April 19, 2024
Individual patient data meta-analysis and systematic review evaluating camostat mesilate to treat COVID-19
Haley Hedlin1, Els Tobback2, Justin Lee1
1Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, CA, USA.
Background:
In the COVID-19 pandemic, several phase II and III randomized trials were launched to evaluate the effectiveness of camostat, an orally administered TMPRSS2 inhibitor previously approved for other indications, for treating SARS-CoV-2 infections. Owing to the rapidly changing landscape during the pandemic, many of these trials were unable to reach completion. Further, methods for synthesizing trials that were launched and not completed were critical.
Methods:
This systematic review aimed to consolidate global evidence by identifying placebo controlled, randomized trials of camostat and analyzing their collective clinical and virologic impact on SARS-CoV-2 through an individual patient data meta-analysis (IPDMA). We harmonized data from the studies and utilized Bayesian statistical models to assess virologic outcomes (measured by the rate of change in viral shedding) and clinical outcomes (based on the time to the first of two consecutive symptom-free days), adjusting for age and sex.
Results:
The IPDMA incorporated data from six countries, totaling 431 patients across the studies; 118 patients contributed data for the primary virologic outcome and 240 for the clinical symptom outcome. Camostat did not improve the rate of change in viral load (difference in rate of change = 0.11 Ct value/day higher, 95% credible interval 2.04 lower to 2.23 higher) or time to symptom resolution (hazard ratio = 0.87, 95% credible interval 0.51, 1.55) when compared to placebo.
Conclusions:
Despite its theoretically promising mode of action, camostat did not demonstrate a statistically significant virologic or clinical benefit in treating COVID-19, highlighting the complexity of drug repurposing in emergency health situations.
Insights
Camostat, an orally administered TMPRSS2 inhibitor, did not show significant benefits in treating COVID-19. This systematic review of randomized trials found no improvement in viral load or symptom resolution compared to placebo.
Area of Science:
- Infectious Diseases
- Pharmacology
- Clinical Trials
Background:
- Several randomized trials investigated camostat, a TMPRSS2 inhibitor, for treating SARS-CoV-2 infections during the COVID-19 pandemic.
- Many trials were discontinued due to the evolving pandemic landscape, necessitating methods to synthesize incomplete study data.
Purpose of the Study:
- To conduct a systematic review and individual patient data meta-analysis (IPDMA) of placebo-controlled randomized trials on camostat for COVID-19.
- To assess the collective clinical and virologic impact of camostat on SARS-CoV-2 infection.
Main Methods:
- Harmonized data from six countries were analyzed using Bayesian statistical models.
- Virologic outcomes (viral shedding rate) and clinical outcomes (time to symptom resolution) were assessed, adjusting for age and sex.
Main Results:
- The IPDMA included data from 431 patients across multiple studies.
- Camostat did not significantly improve the rate of viral load change (difference in rate of change = 0.11 Ct value/day higher) compared to placebo.
- Camostat did not significantly reduce the time to symptom resolution (hazard ratio = 0.87).
Conclusions:
- Camostat did not demonstrate statistically significant virologic or clinical benefits in treating COVID-19.
- The study highlights the challenges of drug repurposing for novel infectious diseases, especially during public health emergencies.