COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001684-89/GB

Not reported

Not reported

2020-04-17

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1) Hospitalised adult (≥16 yrs) 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) 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 Crieria The following criterion will apply until at least 3 patients have been allocated the IMP: 3) intubated and requiring mechanical ventilation

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 10^9/l or White Blood Cell Count < 4.0 x 10^9/l 6) Current participation in another COVID-19 interventional trial 7) Known pregnancy or breastfeeding women 8) Women of child bearing potential who are unwilling to 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. 9) 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 in Table 2. 10) Known HIV or chronic Hepatitis B or C infection 11) Known contraindications to any of the Investigational Medicinal Products 12) Concurrent immunosuppression with biological agents or prednisone dose > 20mg 13) History of haematopoietic stem cell transplant or solid organ transplant 14) Any other indication or medical history, that in the opinion of the local investigator means the patient is unsuitable for trial participation 15) Patients with tuberculosis or other severe infections such as (non-COVID19) sepsis, abscesses, and opportunistic infections requiring treatment 16) Patients with moderate or severe heart failure (NYHA class III/IV) 17) Any other indication or medical history, that in the opinion of the local investigator means the patient is unsuitable for trial participation

2

University of Birmingham

16

None

United Kingdom

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

168

The ratio of the oxygen saturation to fractional inspired oxygen concentration (SpO2/FiO2), measured from randomisation to day 14, hospital discharge, death. SpO2 and FiO2 (or inspired oxygen) are measured as part of routine clinical care at least 4 hourly in intensive care, and 4-6 hourly on the wards for patients receiving active management. The ratio will be derived from these data from the electronic patient record.

nan

Phase 2

[{"arm_notes": "", "treatment_id": 541, "treatment_name": "Gemtuzumab ozogamicin", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]