A long-term follow-up study of patients with coronavirus (COVID-19) associated pneumonia

Long-term follow-up study of patients with COVID-19 associated pneumonia who participated in a designated Genentech/Roche sponsored study or Genentech/Roche supported investigator-initiated placebo-controlled or active-controlled study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11265821

Enrollment

300

Registered

2021-01-21

Start date

2020-10-29

Completion date

Unknown

Last updated

2021-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 pneumonia, COVID-19 (SARS-CoV-2 infection) Infections and Infestations COVID-19 pneumonia, COVID-19 (SARS-CoV-2 infection)

Interventions

To assess long-term outcomes in adult patients who were hospitalized with COVID-19 associated pneumonia. Participants will be recruited from Genentech/Roche sponsored studies or any supported Genentec

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by their legal/authorized representative 2. Aged =18 years at the time of providing informed consent 3. Able to comply with the study procedures, in the investigator's judgment 4. Participated in any Genentech/Roche sponsored study or any supported Genentech/Roche independent investigator study for COVID-19 associated pneumonia (Note: Includes patients who completed or discontinued early from these studies)

Exclusion criteria

Exclusion criteria: 1. Participation in an interventional study at the time of enrollment or plans to enroll in an interventional study during this study 2. 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

Design outcomes

Primary

Measure	Time frame
1. Lung texture analysis of high-resolution computed tomography (HRCT) scan of the chest at baseline, 3, 6, 9, and 12 months 2. Lung function measured using pulmonary function tests at baseline, 3, 6, 9, and 12 months 3. Cardiac function measured using echocardiography at baseline, 3, 6, 9, and 12 months 4. Healthcare resource utilization measured using hospitalization, emergency room visits, urgent care/unscheduled visits, physical therapy, and rehabilitation, in addition to other relevant information collected betweenbaseline, 3, 6, 9, and 12 months 5. Patient-reported health-related quality of life, cognitive function, and respiratory symptoms, measured by the Short Form 36 Question Health Survey Version 2 (SF-36v2), Euro-QoL-5D-5-L (EQ-5D-5L), Living with Idiopathic Pulmonary Fibrosis Symptoms Questionnaire-Modified (L-IPF-M), and Montreal Cognitive Assessment (MoCA) at baseline, 3, 6, 9, and 12 months	—

Measure

Time frame

1. Lung texture analysis of high-resolution computed tomography (HRCT) scan of the chest at baseline, 3, 6, 9, and 12 months 2. Lung function measured using pulmonary function tests at baseline, 3, 6, 9, and 12 months 3. Cardiac function measured using echocardiography at baseline, 3, 6, 9, and 12 months 4. Healthcare resource utilization measured using hospitalization, emergency room visits, urgent care/unscheduled visits, physical therapy, and rehabilitation, in addition to other relevant information collected betweenbaseline, 3, 6, 9, and 12 months 5. Patient-reported health-related quality of life, cognitive function, and respiratory symptoms, measured by the Short Form 36 Question Health Survey Version 2 (SF-36v2), Euro-QoL-5D-5-L (EQ-5D-5L), Living with Idiopathic Pulmonary Fibrosis Symptoms Questionnaire-Modified (L-IPF-M), and Montreal Cognitive Assessment (MoCA) at baseline, 3, 6, 9, and 12 months

—

Secondary

Measure	Time frame
1. Peripheral blood biomarkers measured using circulating markers of inflammation, fibrosis, coagulation, or other emerging exploratory markers of disease biology, as appropriate at baseline, 3, 6, 9, and 12 months 2. SARS-CoV-2 infection measured using symptom guided nasopharyngeal swab for COVID-19 real-time polymerase chain reaction (RT-PCR) between baseline, 3, 6, 9, and 12 months 3. Progression or long-term sequelae of COVID-19 disease measured using patient records at baseline, 3, 6, 9, and 12 months 4. Physical fitness measured using the Six-minute walk test (6MWT) and Borg Scale of Perceived Exertion (optional) at baseline, 3, 6, 9, and 12 months 5. Continuous activity and sleep tracking (optional) captured by a wearable device (such as a smart watch) between baseline and 12 months 6. Prevalence and incidence of COVID-19 antibodies measured from blood samples at baseline, 3, 6, 9, and 12 months	—

Measure

Time frame

1. Peripheral blood biomarkers measured using circulating markers of inflammation, fibrosis, coagulation, or other emerging exploratory markers of disease biology, as appropriate at baseline, 3, 6, 9, and 12 months 2. SARS-CoV-2 infection measured using symptom guided nasopharyngeal swab for COVID-19 real-time polymerase chain reaction (RT-PCR) between baseline, 3, 6, 9, and 12 months 3. Progression or long-term sequelae of COVID-19 disease measured using patient records at baseline, 3, 6, 9, and 12 months 4. Physical fitness measured using the Six-minute walk test (6MWT) and Borg Scale of Perceived Exertion (optional) at baseline, 3, 6, 9, and 12 months 5. Continuous activity and sleep tracking (optional) captured by a wearable device (such as a smart watch) between baseline and 12 months 6. Prevalence and incidence of COVID-19 antibodies measured from blood samples at baseline, 3, 6, 9, and 12 months

—

Countries

United States of America

Contacts

Public ContactClinical Trials

global-roche-genentech-trials@gene.com+1 888-662-6728

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026