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

  • Infectious Diseases
  • COVID-19 Pneumonia
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Completed

This trial runs in
Countries
  • Brazil
  • Mexico
  • Spain
  • United States
Trial Identifier:

NCT04386616 GA42469

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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      Trial Summary

      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. Sponsor
      Phase 2 Phase
      NCT04386616,GA42469 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      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.

      Trial Summary

      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. Sponsor
      Phase 2 Phase
      NCT04386616,GA42469 Trial Identifier
      MSTT1041A, MSTT1041A-matched Placebo, UTTR1147A, UTTR1147A-matched Placebo Treatments
      COVID-19 Pneumonia Condition
      Official Title

      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

      Eligibility criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • 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
      Exclusion Criteria
      • 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

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