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Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA

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更新于：2024-11-01

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项与 Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA 相关的临床试验

NCT06128967 / Recruiting临床3期

An Adaptive, Randomized, doublE-blind, Placebo-controlled, Prospective, Pharmacological interVention Study In Participants With Long COVID-19 Syndrome: REVIVE-TOGETHER Trial

Date of notification letter to the IRB informing start of recruitment activities: October 21, 2023.
Long COVID is a multi-systemic condition comprising often severe and persistent symptoms (longer than 12 weeks) that follow a known episode of COVID-19 and cannot be explained by another medical condition. This condition is observed in up to 15% of all individuals after an acute episode of COVID-19, even in those who had a mild and oligosymptomatic SARS-CoV-2 infection. Around 40% of these patients present symptoms that significantly compromise their daily activities.
There is increasing evidence that LONG COVID is accompanied by dysregulated, persistent and uncontrolled inflammation, often accompanied by the development of an autoreactive immune response, including autoantibodies. Symptoms can last months or years, particularly in cases of chronic fatigue syndrome, with significant proportions of individuals having significant chronic impairment, preventing the performance of work and social activities.

开始日期2023-10-18

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Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA

NCT04727424 / Recruiting临床3期

A Multicenter, Prospective, Adaptive, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Fluvoxamine Plus Budesonide, Fluoxetine Plus Budesonide and Spirulin Platensis, in High Risk Patients With Mild COVID-19

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in patients with early-onset disease and mild symptoms. Experimental studies have demonstrated a potential anti-inflammatory role of Fluvoxamine, Fluoxetine, Budesonide and Spirulin Platensis in SARS-CoV-2 infections and observational studies have suggested a reduced complications in patients with COVID-19 disease.

开始日期2021-01-19

申办/合作机构

Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA

[+5]

NCT04403100 / Unknown status临床3期

Hydroxychloroquine and Lopinavir/ Ritonavir for Hospitalization and Mortality Reduction in Patients With COVID-19 and Mild Disease Symptoms: "The Hope Coalition"

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.

开始日期2020-06-03

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Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA

[+2]

100 项与 Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA 相关的临床结果

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0 项与 Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA 相关的专利（医药）

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项与 Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA 相关的文献（医药）

2023-01-11·The American Journal of Tropical Medicine and Hygiene

Early Treatment with Fluvoxamine among Patients with COVID-19: A Cost-Consequence Model

Article

作者: Forrest, Jamie I. ; Mills, Edward J. ; Wilson, Lindsay A. ; Reis, Gilmar ; Thorlund, Kristian ; Guo, Christina M. ; _, _ ; Mills, Fergal P. ; Boulware, David R.

ABSTRACT.To date, two published randomized trials have indicated a clinical benefit of early treatment with fluvoxamine versus placebo for adults with symptomatic COVID-19. Using the results of the largest of these trials, the TOGETHER trial, we conducted a cost–consequence analysis to assess the health system benefits of preventing progression to severe COVID-19 in outpatient populations in the United States. A decision-analytic model in the form of a decision tree was constructed to evaluate two treatment strategies for high-risk patients with confirmed, symptomatic COVID-19 in the primary analysis: treatment with a 10-day course of fluvoxamine (100 mg twice daily) and current standard-of-care. A secondary analysis comparing a 5-day course of nirmatrelvir–ritonavir was also conducted. We used a time horizon of 28 days. Reported outcomes included cost-savings and hospitalization days avoided. The results of our analysis indicated that administration of fluvoxamine to symptomatic outpatients at high risk of progressing to severe COVID-19 was substantially cost-saving, in the amount of $232 per eligible patient and prevented an average of 0.15 hospital days per patient treated, compared with standard of care. Nirmatrelvir–ritonavir was also shown to be cost-saving despite its higher acquisition cost and provided savings to the healthcare system of $625 per patient treated. These findings suggest that fluvoxamine is likely to be a cost-effective addition to frontline COVID-19 mitigation strategies in many settings, particularly where access to nirmaltrevir–ritonavir or monoclonal antibodies is limited.

2022-03-01·The Lancet Global Health

Fluvoxamine for the treatment of COVID-19 – Author's reply

Letter

作者: Mills, Edward ; Reis, Gilmar

We too are interested in whether fluoxetine might offer benefits over fluvoxamine and are now beginning an evaluation of fluoxetine in our trial.We are also examining fluvoxamine plus inhaled budesonide as a combination.We are intending to evaluate fluvoxamine plus molnupiravir once we can access the antiviral.We carefully avoided known associations that would elicit QTc prolongation and also potential medications that interact with fluvoxamine.We excluded patients on previous selective serotonin reuptake inhibitors.We understand the risks for a patient already on other neuroleptics, and we carefully followed up all patients for drug-induced toxicity or interactions.We have not identified any clin. relevant drug-drug interactions so far in the 1497 enrolled patients.

JAMA Network Open1区 · 医学

Effect of Early Treatment With Hydroxychloroquine or Lopinavir and Ritonavir on Risk of Hospitalization Among Patients With COVID-19

1区 · 医学

ArticleOA

作者: Mills, Edward J. ; Forrest, Jamie I. ; Medeiros Silva, Daniela Carla ; Figueiredo Neto, Adhemar Dias de ; Ribeiro, Luciene Barra ; Thabane, Lehana ; Oliveira, Rosemary ; Moreira Silva, Eduardo Augusto dos Santos ; Guimarães de Almeida, Ana Paula Figueiredo ; Teixeira, Mauro Martins ; Harari, Ofir ; Park, Jay J. H. ; Singh, Gurmit ; Simplicio, Maria Izabel Campos ; Quirino dos Santos, Castilho Vitor ; Reis, Gilmar ; Savassi, Leonardo Cançado Monteiro ; Milagres, Aline Cruz

ImportanceData on the efficacy of hydroxychloroquine or lopinavir-ritonavir for the treatment of high-risk outpatients with COVID-19 in developing countries are needed.ObjectiveTo determine whether hydroxychloroquine or lopinavir-ritonavir reduces hospitalization among high-risk patients with early symptomatic COVID-19 in an outpatient setting.Design, Setting, and ParticipantsThis randomized clinical trial was conducted in Brazil. Recently symptomatic adults diagnosed with respiratory symptoms from SARS-CoV-2 infection were enrolled between June 2 and September 30, 2020. The planned sample size was 1476 patients, with interim analyses planned after 500 patients were enrolled. The trial was stopped after the interim analysis for futility with a sample size of 685 patients. Statistical analysis was performed in December 2020.InterventionsPatients were randomly assigned to hydroxychloroquine (800 mg loading dose, then 400 mg daily for 9 days), lopinavir-ritonavir (loading dose of 800 mg and 200 mg, respectively, every 12 hours followed by 400 mg and 100 mg, respectively, every 12 hours for the next 9 days), or placebo.Main Outcomes and MeasuresThe primary outcomes were COVID-19-associated hospitalization and death assessed at 90 days after randomization. COVID-19-associated hospitalization was analyzed with a Cox proportional hazards model. The trial included the following secondary outcomes: all-cause hospitalization, viral clearance, symptom resolution, and adverse events.ResultsOf 685 participants, 632 (92.3%) self-identified as mixed-race, 377 (55.0%) were women, and the median (range) age was 53 (18-94) years. A total of 214 participants were randomized to hydroxychloroquine; 244, lopinavir-ritonavir; and 227, placebo. At first interim analysis, the data safety monitoring board recommended stopping enrollment of both hydroxychloroquine and lopinavir-ritonavir groups because of futility. The proportion of patients hospitalized for COVID-19 was 3.7% (8 participants) in the hydroxychloroquine group, 5.7% (14 participants) in the lopinavir-ritonavir group, and 4.8% (11 participants) in the placebo group. We found no significant differences between interventions for COVID-19-associated hospitalization (hydroxychloroquine: hazard ratio [HR], 0.76 [95% CI, 0.30-1.88]; lopinavir-ritonavir: HR, 1.16 [95% CI, 0.53-2.56] as well as for the secondary outcome of viral clearance through day 14 (hydroxychloroquine: odds ratio [OR], 0.91 [95% CI, 0.82-1.02]; lopinavir-ritonavir: OR, 1.04 [95% CI, 0.94-1.16]). At the end of the trial, there were 3 fatalities recorded, 1 in the placebo group and 2 in the lopinavir-ritonavir intervention group.Conclusions and RelevanceIn this randomized clinical trial, neither hydroxychloroquine nor lopinavir-ritonavir showed any significant benefit for decreasing COVID-19-associated hospitalization or other secondary clinical outcomes. This trial suggests that expedient clinical trials can be implemented in low-income settings even during the COVID-19 pandemic.Trial RegistrationClinicalTrials.gov Identifier: NCT04403100.

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100 项与 Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA 相关的转化医学

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