ArticleEClinicalMedicine2024
Efficacy of oral 20-hydroxyecdysone (BIO101), a MAS receptor activator, in adults with severe COVID-19 (COVA): a randomized, placebo-controlled, phase 2/3 trial.
Article in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04472728 (Adaptive Design, Phase 2-3, Randomized, Double-blind, Multicenter Study, Evaluating Safety, Efficacy, PK-PD of BIO101 in Prevention of Respiratory Deterioration in Hospitalized Patients With COVID-19 Pneumonia), which is not on this map. Cited by 17 papers.
What it found
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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.
Adaptive Design, Phase 2-3, Randomized, Double-blind, Multicenter Study, Evaluating Safety, Efficacy, PK-PD of BIO101 in Prevention of Respiratory Deterioration in Hospitalized Patients With COVID-19 Pneumonia (Severe)
Who cites it
17 citing papers in PubMed, 26 citations in OpenAlex.
- How reliable is the labeling of a commercial phytosteroid product? A 12-week randomized double-blind training study.Journal of the International Society of Sports Nutrition · 2025Trial
- BIO101 in Sarcopenic Seniors at Risk of Mobility Disability: Results of a Double-Blind Randomised Interventional Phase 2b Trial.Journal of cachexia, sarcopenia and muscle · 2025Trial
- Protective Arm of Renin-Angiotensin System: Evidence of Nephroprotective Effects Against Acute Kidney Injury.Acta physiologica (Oxford, England) · 2026Review
- The balance between classical and alternative renin-angiotensin system in ARDS: a narrative review.Journal of intensive care · 2026Review
- Development of pharmacological interventions for the treatment of sarcopenia.Annals of translational medicine · 2026Review
- Therapeutic potential of 20-Hydroxyecdysone in pulmonary arterial hypertension: involvement of Mas receptor and PI3K-Akt pathway.Cellular & molecular biology letters · 2026Article
- Therapeutic Opportunities Targeting the ACE2/Ang-(1-7)/MasR Pathway in Cardiometabolic Disease.Current hypertension reports · 2026Review
- Antiviral Activity of Plant-Based Preparations against SARS-CoV-2 and Herpes Simplex Virus Type 2 In Vitro: A Review of Experimental Findings.Bulletin of experimental biology and medicine · 2025Review
- Neuroprotective Effect of Mas Activation by BIO101 in Vincristine-Induced Small Fiber Neuropathy.Journal of the peripheral nervous system : JPNS · 2025Article
- Computational drug repurposing: approaches, evaluation of in silico resources and case studies.Nature reviews. Drug discovery · 2025Review
- LC-MS/MS Fingerprinting Analysis ofACS omega · 2025Article
- Review
- Intranasal liposomal angiotensin-(1-7) administration reduces inflammation and viral load in the lungs during SARS-CoV-2 infection in K18-hACE2 transgenic mice.Antimicrobial agents and chemotherapy · 2024Article
- 20-Hydroxyecdysone Boosts Energy Production and Biosynthetic Processes in Non-Transformed Mouse Cells.Antioxidants (Basel, Switzerland) · 2024Article
- Angiotensin-(1-7) decreases inflammation and lung damage caused by betacoronavirus infection in mice.Inflammation research : official journal of the European Histamine Research Society ... [et al.] · 2024Article
- Angiotensin-(1-7) infusion in COVID-19 patients admitted to the ICU: a seamless phase 1-2 randomized clinical trial.Annals of intensive care · 2024Article
- Alternative Renin-Angiotensin System.Hypertension (Dallas, Tex. : 1979) · 2024Review
Corrections and comments
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Authors and funding
51 authors at 20 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: SARS-CoV-2 binding to ACE2 is potentially associated with severe pneumonia due to COVID-19. The aim of the study was to test whether Mas-receptor activation by 20-hydroxyecdysone (BIO101) could restore the Renin-Angiotensin System equilibrium and limit the frequency of respiratory failure and mortality in adults hospitalized with severe COVID-19. Methods: Double-blind, randomized, placebo-controlled phase 2/3 trial. Randomization: 1:1 oral BIO101 (350 mg BID) or placebo, up to 28 days or until an endpoint was reached. Primary endpoint: mortality or respiratory failure requiring high-flow oxygen, mechanical ventilation, or extra-corporeal membrane oxygenation. Key secondary endpoint: hospital discharge following recovery (ClinicalTrials.gov Number, NCT04472728). Findings: Due to low recruitment the planned sample size of 310 was not reached and 238 patients were randomized between August 26, 2020 and March 8, 2022. In the modified ITT population (233 patients; 126 BIO101 and 107 placebo), respiratory failure or early death by day 28 was 11.4% lower in the BIO101 (13.5%) than in the placebo (24.3%) group, (p = 0.0426). At day 28, proportions of patients discharged following recovery were 80.1%, and 70.9% in the BIO101 and placebo group respectively, (adjusted difference 11.0%, 95% CI [-0.4%, 22.4%], p = 0.0586). Hazard Ratio for time to death over 90 days: 0.554 (95% CI [0.285, 1.077]), a 44.6% mortality reduction in the BIO101 group (not statistically significant). Treatment emergent adverse events of respiratory failure were more frequent in the placebo group. Interpretation: BIO101 significantly reduced the risk of death or respiratory failure supporting its use in adults hospitalized with severe respiratory symptoms due to COVID-19. Funding: Biophytis.
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