ISRCTN30448031进行中（未招募）未知
Platform Adaptive trial of Novel antivirals for early treatment of COVID-19 in the community
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 29,295
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36566761/ Molnupiravir results (added 28/12/2022) 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37550022/ (added 09/08/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38396069/ molnupiravir SARS-CoV-2 viral and antibody response (added 26/02/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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