COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621000016831.aspx

Dr Raphael Udeh

Raphael.Udeh@uon.edu.au

2021-01-13

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

1. Adult greater than or equal to 18 years, male or non-pregnant female at the time of enrolment. 2. Laboratory confirmed (RT-PCR) COVID-19 infection. 3. Able to give informed consent or by their legal representative for ICU patients who are unable to sign. 4. Must agree to comply with the study procedure. 5. On hospital admission with SPO2 less than or equal to 94% or needs mechanical ventilation or needs supplemental oxygen. 6. Must agree not to join any other clinical trial for COVID-19 throughout this study period [day 1 to day 28]

1. Patients with severely deranged liver function (the hepatic transaminases more than 5x the upper limit of normal). 2. Severely deranged kidney function (with estimated glomerular filtration rate, eGFR less than or equal to 30ml/min/1.73m2 or patients on kidney replacement support). 3. Any plan of discharge in the next 72hours to a hospital that is not one of our study sites. 4. Breast-feeding or pregnant adult female. 5. History of allergy to the study drug. Good to note that women of child-bearing age will be advised and encouraged to adhere to safe and effective contraceptive measures.

2

Hunter medical research institute

18

100

Australia

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

125

Time from the first day of randomization to the 28th day of study completion; that a participant achieves a two-point decrease in their admission status using a six-point ordinal scale or discharged alive from the hospital (depending on which comes first). The seven-point scale has been used in clinical trial for severe influenza; modified into a six-point scale due to the protracted course of COVID-19. The six-point ordinal scale ranges from 1-discharged or about to; Discharge criteria is defined by no fever; normal breathing (<24cpm); Sa02>94%; cough relieved; all sustained for not less than 3 days; 2-hospitalized but does not need oxygen treatment; 3-hospitalized and needs oxygen but not high flow or non-invasive ventilation; 4-hospitalized and needs high flow or non-invasive ventilation; 5-hospitalized for ECMO or invasive ventilation; to 6-death. [Time to two-point decrease in the six-point ordinal scale. To be assessed daily from 1st day of randomization till day 28 from randomization]

Phase 2

[{"arm_notes": "", "treatment_id": 1264, "treatment_name": "Tasquinimod", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]