Conv. Plasma
Nigella Sativa
Nitric Oxide
Peg.. Lambda

Home   COVID-19 treatment studies for Proxalutamide  COVID-19 treatment studies for Proxalutamide  C19 studies: Proxalutamide  Proxalutamide   Select treatmentSelect treatmentTreatmentsTreatments
Alkalinization Meta Lactoferrin Meta
Melatonin Meta
Bromhexine Meta Metformin Meta
Budesonide Meta Molnupiravir Meta
Cannabidiol Meta
Colchicine Meta Nigella Sativa Meta
Conv. Plasma Meta Nitazoxanide Meta
Curcumin Meta Nitric Oxide Meta
Ensovibep Meta Paxlovid Meta
Famotidine Meta Peg.. Lambda Meta
Favipiravir Meta Povidone-Iod.. Meta
Fluvoxamine Meta Quercetin Meta
Hydroxychlor.. Meta Remdesivir Meta
Iota-carragee.. Meta
Ivermectin Meta Zinc Meta

Other Treatments Global Adoption
All Studies   All Outcomes   Recent:  
Proxalutamide (GT0918) Improves Lung Injury in Hospitalized COVID-19 Patients -an Analysis of the Radiological Findings of the Proxa-Rescue AndroCoV Trial
Medeiros et al., ResearchGate (Preprint), NCT04728802 (history)
Medeiros et al., Proxalutamide (GT0918) Improves Lung Injury in Hospitalized COVID-19 Patients -an Analysis of the Radiological.., ResearchGate (Preprint), NCT04728802
Jul 2021   Source   PDF  
  All Studies   Meta
Analysis of radiological findings from the Proxa-Rescue AndroCoV trial showing that proxalutamide significantly improves lung opacities compared to placebo. NCT04728802 (history).
Medeiros et al., 1 Jul 2021, preprint, 23 authors, trial NCT04728802 (history).
All Studies   All Outcomes   Submit Updates or Corrections
This PaperProxalutamideAll
Proxalutamide Improves Lung Injury in Hospitalized COVID-19 Patients – an Analysis of the Radiological Findings of the Proxa-Rescue AndroCoV Trial
MD, PhD1 Flávio Adsuara Cadegiani, Daniel Do Nascimento Fonseca, Michael Do Nascimento Correia, Renan Nascimento Barros, Dirce Costa Onety, Karla Cristina Petruccelli Israel, Emilyn Oliveira Guerreiro, José Erique Miranda Medeiros, Raquel Neves Nicolau, Luiza Fernanda Mendonça Nicolau, Rafael Xavier Cunha, Maria Fernanda Rodrigues Barroco, Patrícia Souza Da Silva, Raysa Wanzeller De Souza Paulain, Claudia Elizabeth Thompson, Ricardo Ariel Zimerman, MD, PhD10 Carlos Gustavo Wambier, Andy Goren
Introduction: Antiandrogen are good candidates against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (COVID-19) due to the inhibition of its entry into host cells by the suppression of TMPRSS2, an enzyme that primes the SARS-CoV-2 spike (S) protein and is key for its cell entry. Proxalutamide is a secondgeneration nonsteroidal anti-androgen (NSAA) with strong activities on androgen receptor (AR) antagonism, suppression of AR nuclear expression, and downregulation of the membrane-attached angiotensin converting enzyme-2 (ACE2). The efficacy of proxalutamide was previously demonstrated for early COVID-19 patients, and has now demonstrated efficacy to reduce deaths in hospitalized COVID-19 patient in a doubleblind, placebo-controlled randomized clinical trial (RCT). Whether radiological changes would follow the improvement in clinical outcomes with proxalutamide is not established. The present post-hoc analysis aims to evaluate whether proxalutamide improves lung injury observed through chest computed tomography (CT) scans, in addition to the clinical improvement, thus providing further objective evidence of the drug response in COVID-19. Methods: This is a post-hoc analysis of the radiological findings of a double-blinded, placebo-controlled, prospective, two-arm RCT (The Proxa-Rescue AndroCoV Trial) with all enrolled patients from the three participating institutions of the city of Manaus, Amazonas, Brazil, that had at least two chest CT scans during hospitalization. The quantification of lung parenchyma involvement was performed by independent boardcertified radiologists with expertise in analysis of COVID-19 images, that were blind to the assigned intervention in the RCT. A first chest CT scan was performed upon randomization and a second CT scan was performed approximately five days later, whenever patient transportation was feasible. Results: Of the 395 patients initially evaluated, 72 and 179 patients from the proxalutamide and placebo arms, respectively, were included (n=251). Baseline and clinical characteristics, interval between first and second chest CT scans, and percentage of lung parenchyma affected in the baseline chest CT scan were similar between groups. In the second chest CT scan, the percentage of lungs affected (Median -IQR) was 35.0% (25.0-57.5%) in the proxalutamide group versus 67.5% (50.0-80.0%) in the placebo group (p < 0.001). The absolute and relative change between the second and first chest CT scans (Median -IQR) were -15.0 percent points (p.p.) (-30.0 -0.0p.p.) and -25.0% (-50.0 -0.0%) in the proxalutamide group, respectively, and +15.0p.p. (0.0 -+30.0p.p.) and +32.7% (0.0 -+80.0%) in the placebo group, respectively (p < 0.001 for both absolute and relative changes). Conclusion: Proxalutamide improves lung opacities in hospitalized COVID-19 patients when compared to placebo. (NCT04728802)
Cadegiani, Mccoy, Wambier, Proxalutamide Significantly Accelerates Viral Clearance and Reduces Time to Clinical Remission in Patients with Mild to Moderate COVID-19: Results from a Randomized, Double-Blinded, Placebo-Controlled Trial
Chamorro, Tascón, Sanz, Vélez, Nacenta, Radiologic diagnosis of patients with COVID-19. Diagnóstico radiológico del paciente con COVID-19, Radiologia (Engl Ed), doi:10.1016/j.rx.2020.11.001
Envelope, Create a blocked randomisation list
Faria, Mellan, Whittaker, Claro, Candido et al., Genomics and epidemiology of a novel SARS-CoV-2 lineage in Manaus, Brazil, Science, doi:10.1101/2021.02.26.21252554
Figure, Legend, Procotol flowchart -Analysis of the chest CT scans in the Proxa-Rescue AndroCoV Trial
Hani, Trieu, Saab, Dangeard, Bennani et al., COVID-19 pneumonia: a review of typical CT findings and differential diagnosis, Diagn Interv Imaging
Hoffmann, Kleine-Weber, Schroeder, SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor, Cell
Li, Han, Dai, Distinct mechanisms for TMPRSS2 expression explain organ-specific inhibition of SARS-CoV-2 infection by enzalutamide, Nat Commun
Lin, Ferguson, White, Prostate-localized and androgen-regulated expression of the membrane-bound serine protease TMPRSS2, Cancer Res
Mader, Bernatz, Michalik, Koch, Martin et al., Quantification of COVID-19 Opacities on Chest CT -Evaluation of a Fully Automatic AIapproach to Noninvasively Differentiate Critical Versus Noncritical Patients, Acad Radiol, doi:10.1016/j.acra.2021.03.001
Mccoy, Goren, Cadegiani, Vaño-Galván, Kovacevic et al., Proxalutamide (GT0918) Reduces the Rate of Hospitalization for COVID-19 Male Outpatients: A Randomized Double-Blinded Placebo-Controlled Trial, Front. Med, doi:10.3389/fmed.2021.668698
Pocock, Assmann, Enos, Kasten, Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems, Stat Med
Prokop, Van Everdingen, Van Rees, Vellinga, Quarles Van Ufford et al., CO-RADS-a categorical CT assessment scheme for patients with suspected COVID-19: definition and evaluation, Radiology
Qiao, Wang, Mannan, Targeting transcriptional regulation of SARS-CoV-2 entry factors ACE2 and TMPRSS2, Proc Natl Acad Sci U S A
Qiblawey, Tahir, Chowdhury, Khandakar, Kiranyaz et al., Detection and Severity Classification of COVID-19 in CT Images Using Deep Learning, Diagnostics, doi:10.3390/diagnostics11050893
Qu, Gu, Wang, Metabolomic profiling to evaluate the efficacy of proxalutamide, a novel androgen receptor antagonist, in prostate cancer cells, Invest New Drugs
Ranzani, Bastos, Gelli, Marchesi, Baião et al., Characterisation of the first 250,000 hospital admissions for COVID-19 in Brazil: a retrospective analysis of nationwide data, Lancet Respir Med
Shan, Gao, Wang, Shi, Shi et al., Abnormal lung quantification in chest CT images of COVID-19 patients with deep learning and its application to severity prediction, Med Phys, doi:10.1002/mp.14609
Sr, Massaro, Sullivan, Non-inferiority trials: design concepts and issues -the encounters of academic consultants in statistics, Stat Med
Tran, Ouk, Clegg, Development of a second-generation antiandrogen for treatment of advanced prostate cancer, Science
Wambier, Goren, Vaño-Galván, Androgen sensitivity gateway to COVID-19 disease severity, Drug Dev Res
Wang, Dong, Hu, Li, Ren et al., Temporal changes of CT findings in 90 patients with COVID-19 pneumonia: a longitudinal study, Radiology
Wang, Xu, Wang, Feng, An et al., CT characteristics of patients infected with 2019 novel coronavirus: association with clinical type, Clin Radiol
Wu, Miao, Zhou, Suppression of Androgen Receptor (AR)-ACE2/TMPRSS2 Axis by AR Antagonists May Be Therapeutically Beneficial for Male COVID-19 Patients, SSRN Electron J
Yuan, Yin, Tao, Tan, Hu, Association of radiologic findings with mortality of patients infected with 2019 novel coronavirus in Wuhan, China, PLoS One
Zhang, Xu, Zhou, Chen, Li et al., Clinical characteristics and chest CT imaging features of critically ill COVID-19 patients, Eur Radiol
Zhao, Zhong, Xie, Yu, Liu, Relation between chest CT findings and clinical conditions of coronavirus disease (COVID-19) pneumonia: a multicenter study, AJR Am J Roentgenol
Late treatment
is less effective
Please send us corrections, updates, or comments. Vaccines and treatments are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
  or use drag and drop