COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN30448031

Christopher Butler

Not reported

2021-11-03

Recruiting

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

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 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

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

2

University of Oxford

18

50

United Kingdom

No restriction on type of patients

0: No restriction on type of patients

5319

Non-elective hospitalisations/deaths in higher risk; symptomatic patients with confirmed COVID-19 within 28 days of randomisation measured using patient records.

Not reported

[{"arm_notes": "", "treatment_id": 813, "treatment_name": "Molnupiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]