COVID-19 MedDRA version: 20.1 Level: HLT Classification code 10047468 Term: Viral lower respiratory tract infections System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Mylotarg
Product Name: Mylotarg
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: Gemtuzumab ozogamicin
CAS Number: 220578-59-6
Concentration unit:
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Are the trial subjects under 18? yes Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 96 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 156
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the CATALYST Trial are to measure the change over time in the amount of oxygen being carried in the blood compared to the amount of oxygen being breathed in, in patients with COVID-19. ;Secondary Objective: We also want to look at: 1) How good is the treatment (and usual care) over time and whether this leads to an improvement in the patient's overall condition/ wellbeing 2) Clinical measures such as breathing rate, body temperature, how long you are in hospital for 3) Levels and changes in certain blood test results 4) Looking at how safe these treatments are by looking at their side effects treatments;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: measured from baseline to day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Efficacy measure (randomisation to day 7, 14 and 28) o Time to improvement; improvement defined as at least a one-point improvement on the Clinical Progression improvement Scale (1-10 scale; for the purposes of this trial level 0, no viral RNA detected, will not be assessed) [WHO R&D Blueprint Group]. o Clinical Progression Scale [WHO R&D Blueprint Group] at randomisation, day 7, 14 and 28 • Clinical measures o Respiratory rate o Body Temperature o Length of hospital stay o Hospital survival status at day 28 o Proportion of patients discharged at day 28 o Destination of discharge • Routine laboratory measurment (baseline, days 1, 3, 7 and 14) o C-reactive protein (CRP) o Full blood count with neutrophil:lymphocyte ratios o Ferritin, D-Dimer, LDH and triglycerides • Safety measures o Adverse events as recorded by Common Terminology Criteria for Adverse Events (CTCAE), version 4.03 (Appendix 1 )of grade =3 with interest in veno- occlusive disease, secondary infection and allergic reaction. o Survival status ;Timepoint(s) of evaluation of this end point: Varies dependent on endpoints - time points are indicated for each one above | — |
Countries
United Kingdom
Outcome results
None listed