COVID-19 (SARS-Cov-2-infection) Infections and Infestations
Conditions
Interventions
A platform trial, in contrast to say a traditional two-arm design, allows multiple arms to be considered simultaneously, and interventions can be dropped and replaced as evidence emerges for effective
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 02/11/2022: 1. Participant is able and willing to provide informed consent, or their legal representative is willing to provide informed consent 2. Symptoms attributable to COVID-19 started within the past 5 days and ongoing 3. A positive PCR or lateral flow SARS-CoV-2 test* 4. Aged =50 years OR aged 18-49 years with one of the following known underlying chronic health conditions considered to make them clinically vulnerable: 4.1. Chronic respiratory disease (including chronic obstructive pulmonary disease (COPD), cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication) 4.2. Chronic heart or vascular disease 4.3. Chronic kidney disease 4.4. Chronic liver disease 4.5. Chronic neurological disease (including dementia, stroke, epilepsy) 4.6. Severe and profound learning disability 4.7. Down’s syndrome 4.8. Diabetes mellitus (Type or Type II) 4.9. Immunosuppression: primary (e.g., inherited immune disorders resulting from genetic mutations, usually present at birth and diagnosed in childhood) or secondary due to disease or treatment (e.g., sickle cell, HIV, cancer, chemotherapy) 4.10. Solid organ, bone marrow and stem cell transplant recipients 4.11. Morbid obesity (BMI >35) 4.12. Severe mental illness 4.13. Care home resident 4.14. Judged by recruiting medically qualified professional, research nurse, nurse prescriber, prescribing pharmacist, dependent on the ISA for the specific IMP involved, to be clinically vulnerable *Any positive PCR or lateral flow test taken up to two days before symptom onset and randomisation qualifies. Previous participant inclusion criteria: 1. Participant or their legal representative is able and willing to provide informed consent 2. Symptoms attributable to COVID-19 started within the past 5 days and ongoing 3. A positive PCR or lateral flow SARS-CoV-2 test within the past 7 days 4. Aged =50 years OR aged 18-49 years with any known underlying chronic health condition considered to make them clinically vulnerable: 4.1. chronic respiratory disease (including chronic obstructive pulmonary disease (COPD), cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication) 4.2. chronic heart or vascular disease 4.3. chronic kidney disease 4.4. chronic liver disease 4.5. chronic neurological disease (including dementia, stroke, epilepsy) 4.6. severe and profound learning disability 4.7. Down’s syndrome 4.8. diabetes mellitus (Type or Type II) 4.9. immunosuppression due to disease or treatment (e.g., sickle cell, HIV, cancer, chemotherapy) 4.10. solid organ, bone marrow and stem cell transplant recipients 4.11. morbid obesity (BMI >35) 4.12. severe mental illness 4.13. care home resident 4.14. judged by recruiting clinician or research nurse (registered medical practitioner or trained study nurse) to be clinically vulnerable
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 02/11/2022: 1. Patient currently admitted to hospital (inpatient) 2. Previous randomisation in the PANORAMIC trial 3. Currently participating in a clinical trial of a therapeutic agent for acute COVID-19 4. Additional exclusions specific to each intervention arm, if any, as listed in the Intervention Specific Appendices (ISA’s) of currently open trial arms Previous participant exclusion criteria: 1. Patient currently admitted to hospital 2. Previous randomisation in the PANORAMIC trial 3. Currently participating in a clinical trial of a therapeutic agent for acute COVID-19 4. Participation in an investigational COVID-19 vaccine trial within previous 28 days 5. Additional exclusions specific to each intervention arm, if any, as listed in the Intervention Specific Appendices (ISA’s) of currently open trial arms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-elective hospitalisations/deaths in higher risk, symptomatic patients with confirmed COVID-19 within 28 days of randomisation measured using patient records. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to recovery (defined as the first instance that a participant report feeling recovered from the illness) measured using daily online symptom scores. Telephone call or text on days 7, 14 and 28 if data is not obtained through the online diary. Also, at 3 and 6 months. 2. Participant reported illness severity, reported by daily rating of how well participant feels, enabling identification of sustained recovery. 3. Duration of severe symptoms and symptom recurrence measured using GP notes review if available through Oxford RCGP RSC network; otherwise, other sources of routinely collected data after 28 days. Medical notes review for up to 10 years. 4. Contacts with the health services reported by patients and/or captured by reports of patients’ medical records up to 12 months 5. New infections in household measured using daily diary for 28 days 6. To investigate the safety of antiviral agents measured by the monitoring of adverse events (AEs as defined in the ISAs) up to 6 months 7. Longer term effects measured using patient contact at three and six months, electronic medical record search for up to one year 8. Cost effectiveness measured using resource use and cost data and EQ-5D-5L at baseline and day 28 | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed