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

For Patient
For Medical Professional
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Basic Details

Gender

All

Age

≥18 Years

Healthy Volunteers

Sponsor Genentech, Inc.

Phase Phase 2

Study Identifier NCT04386616, GA42469

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.

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

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

Results Disclaimer

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

Basic Details

Sponsor Genentech, Inc.

Phase Phase 2

Trial Identifier NCT04386616, GA42469

Condition COVID-19 Pneumonia

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

Study 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.

Eligibility Criteria

Gender

All

Age

≥18 Years

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

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

Results Disclaimer

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

Basic Details

What you can do next

What is Clinical Research?

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

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

Contact Genentech

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Find participating medical centers and current study status in each of them

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

Basic Details

What you can do next

Find participating medical centers and current study status in each of them

Explore related studies

What is Clinical Research?

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