A study to find out if a new medicine (either astegolimab or efmarodocokin alfa) was safe and effective in patients with severe COVID-19 pneumonia

A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia

  • Doenças Infecciosas
  • Pneumonia por COVID-19
Observe que o status de recrutamento do estudo em seu centro pode ser diferente do status geral do estudo porque alguns centros de estudo podem recrutar mais cedo do que outros.
Status do estudo:

Concluído

Este estudo é realizado em
Cidades
  • Rio de Janeiro
  • Rio Grande do Sul
  • São Paulo
Identificador de estudo:

NCT04386616 GA42469

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      A seguinte informação vem do site ClinicalTrials.gov publicamente disponível e foi editada para leigos.

      As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.

      Results Disclaimer

      Resumo do Estudo

      This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) compared with placebo and of UTTR1147A compared with placebo, in combination with standard of care (SOC), in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.

      Genentech, Inc. Patrocinador
      Phase 2 Fase
      NCT04386616, GA42469 Identificação do Estudo
      All Gênero
      ≥18 Years Idade
      No Voluntários Saudáveis

      This clinical trial was done to study two new medicines called, astegolimab” and “efmarodocokin alfa”, for the treatment of patients with severe COVID-19 pneumonia. This study was done to find out if either medicine was effective and safe for treating patients with severe COVID-19 pneumonia in comparison to placebo treatments. There were 396 patients who took part in this study at 54 study centers in 4 countries.

      Resumo do Estudo

      This is a Phase II, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of MSTT1041A (astegolimab) compared with placebo and of UTTR1147A compared with placebo, in combination with standard of care (SOC), in patients hospitalized with severe coronavirus disease 2019 (COVID-19) pneumonia.

      Genentech, Inc. Patrocinador
      Phase 2 Fase
      NCT04386616, GA42469 Identificador de estudo
      MSTT1041A, MSTT1041A-matched Placebo, UTTR1147A, UTTR1147A-matched Placebo Tratamento
      COVID-19 Pneumonia Condição
      Título

      A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MSTT1041A or UTTR1147A in Patients With Severe COVID-19 Pneumonia

      Critérios de elegibilidade

      Todos Gênero
      ≥18 Anos Idade
      Não Voluntários Saudáveis
      Critérios de Inclusão
      • Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest X-ray or CT scan
      • Peripheral capillary oxygen saturation (SpO2) ≤93% (on room air or supplemental oxygen) or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤300 millimetres of mercury (mmHg) or requiring supplemental oxygen to maintain SpO2 >93% or requirement for supplemental oxygen to maintain SpO2 at an acceptable level per local standard of care
      Critérios de Exclusão
      • Pregnant or breastfeeding, or positive pregnancy test at screening
      • Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
      • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
      • Participating in another clinical drug trial
      • Treatment with investigational therapy (other than for COVID-19) within 5 half-lives or 30 days (whichever is longer) prior to initiation of study drug
      • Use of Janus kinase (JAK) inhibitor within 30 days or 5 drug elimination half-lives (whichever is longer) prior to screening
      • Have received high-dose systemic corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) within 72 hours prior to Day 1
      • Known HIV infection with CD4 <200 cells/microlitre (uL) or <14% of all lymphocytes
      • ALT or AST >10 times the upper limit of normal (ULN) detected at screening
      • History of anaplastic large-cell lymphoma or mantle-cell lymphoma
      • History of cancer within the previous 5 years unless it has been adequately treated and considered cured or remission-free in the investigator's judgment
      • Clinical evidence of active or unstable cardiovascular disease (e.g., acute myocardial ischemia or decompensated heart failure), as determined by investigator assessment, ECG, laboratory assessment, or echocardiographic data
      • History of moderate or severe allergic, anaphylactic, or anaphylactoid reactions or hypersensitivity to any component of study treatment

      For the latest version of this information please go to www.forpatients.roche.com

       

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