ISRCTN40580903已完成2 期
A randomised phase II proof of principle multi-arm multi-stage trial designed to guide the selection of interventions for phase III trials in hospitalised patients with COVID-19 infection.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
研究概览
简要总结
2021 Preprint results in https://doi.org/10.1101/2021.06.02.21258204 non-peer-reviewed results in preprint (added 11/06/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34922649/ (added 20/12/2021) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34764169/ (added 30/08/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria approved from 12/10/2020, updated 27/08/2021:
- •1. Hospitalised adult (=16 yrs) patients with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription polymerase chain reaction [RT-PCR] assay)
- •2. CRP =40 mg/l
- •Arm 2: (Usual Care + Gemtuzumab Ozogamicin) Specific Inclusion Criteria (NB. THIS ARM IS NOT RECRUITING AT THIS TIME)
- •The following criterion will apply until at least three patients have been allocated the IMP: intubated and requiring mechanical ventilation
- •Previous inclusion criteria from 01/07/2020:
- •1. Hospitalised adult (=16 yrs) patients with a clinical picture strongly suggestive of SARS-CoV-2 pneumonia (confirmed by chest X-ray or CT scan, with or without a positive reverse transcription polymerase chain reaction [RT-PCR] assay)
- •2. Oxygen saturation (SaO2) of =94% while breathing ambient air or a ratio of the partial pressure of Oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2:FiO2) = 300 mg Hg (=40kPa)
- •Arm 2: (Usual Care + Gemtuzumab Ozogamicin) Specific Inclusion Criteria (NB. THIS ARM IS NOT RECRUITING AT THIS TIME)
- •The following criterion will apply until at least 3 patients have been allocated the IMP: intubated and requiring mechanical ventilation
- •Original inclusion criteria:
- •1. Hospitalized patients with a laboratory-confirmed diagnosis of SARS-CoV-2 pneumonia (confirmed by reverse transcription polymerase chain reaction [RT-PCR] assay and chest X-ray)
- •2. Aged =16 years
- •3. Oxygen saturation (SaO2) of =94% while breathing ambient air or a ratio of the partial pressure of Oxygen (PaO2) to the fraction of inspired oxygen (FiO2) (PaO2:FiO2) =300 mgHg (=40kPa)
- •4. Participants recruited up until 3 patients are included in Arm 2 (usual care + gemtuzumab ozogamicin) must be intubated and requiring mechanical ventilation
排除标准
- •Current exclusion criteria approved from 12/10/2020, updated 27/08/2021:
- •1. Patient or legal representative refusal
- •2. Receiving palliative care with no active treatment
- •3. Current participation in another COVID-19 interventional trial. Co-enrolment into RECOVERY-RS is allowed
- •4. Known pregnancy or breastfeeding women
- •5. Women of child bearing potential who are unwilling to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the duration of the trial and the maximum period specified in Table 2.
- •6. Non-vasectomised men, sexually active with women of childbearing potential, who are not willing to practise effective contraception (i.e. condom with spermicide) for the duration of the trial and the maximum period specified in Table 2.
- •7. Known HIV or chronic Hepatitis B or C infection
- •8. Known contraindications to any of the Investigational Medicinal Products (IMPs)
- •9. Concurrent immunosuppression with biological agents
- •10. History of haematopoietic stem cell transplant or solid organ transplant
- •11. Known hypersensitivity to drug products or excipients
- •12. Patients with tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, and opportunistic infections requiring treatment
- •13. Patients with moderate or severe heart failure (NYHA class III/IV)
- •14. Any other indication or medical history, that in the opinion of the local investigator means the patient is unsuitable for trial participation
- •Previous exclusion criteria from 01/07/2020:
- •1. Patient or legal representative refusal
- •2. Receiving palliative care with no active treatment
- •3. Known veno-occlusive disease
- •4. Chronic Obstructive Pulmonary Disease (known FEV1 < 50% predicted or ambulatory or long term oxygen therapy)
- •5. Neutrophil count < 2 x 109/l or White Blood Cell Count < 4.0 x 109/l
- •6. Current participation in another COVID-19 interventional trial. Co-enrolment into
- •7. RECOVERY-RS is allowed
- •8. Known pregnancy or breastfeeding women
- •9. Women of child bearing potential who are unwilling to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the duration of the trial and the maximum period specified below.
- •10. Non-vasectomised men, sexually active with women of child bearing potential, who are not willing to practise effective contraception (i.e. condom with spermicide) for the duration of the trial and the maximum period specified below.
- •11. Known HIV or chronic Hepatitis B or C infection
- •12. Known contraindications to any of the Investigational Medicinal Products (IMPs)
- •13. Concurrent immunosuppression with biological agents
- •14. History of haematopoietic stem cell transplant or solid organ transplant
- •15. Known hypersensitivity to drug products or excipients
- •16. Patients with tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, and opportunist
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