A Study to Evaluate the Safety and Efficacy of MSTT1041A or UTTR1147A in Patients with Severe Covid-19 Pneumonia

Phase 1

• Conditions: Severe coronavirus disease 2019 (COVID-19) pneumonia; MedDRA version: 23.0Level: LLTClassification code 10084383Term: Novel COVID-19-infected pneumoniaSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002713-17-ES
• Lead Sponsor: Genentech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-20
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age >=18 years
• Hospitalized with COVID-19 pneumonia confirmed per WHO criteria and evidenced by chest X-ray or CT scan
• Peripheral capillary oxygen saturation (SpO2) <= 93% or partial pressure of oxygen/fraction of inspired oxygen <= 300 mmHg or requiring supplemental oxygen to maintain SpO2 > 93%
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 105

Exclusion Criteria

• 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 prior to initiation of study drug
• Use of Janus kinase inhibitor within 30 days or 5 drug elimination half-lives prior to screening
• Have received high-dose systemic corticosteroids within 72 hours prior to Day 1
• Known HIV infection with CD4< 200 cells/micro liter or <14% of all lymphocytes
• Alanine aminotransferase and aspartate aminotransferase >10× 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 assessed by the 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified