COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45649

Dr Devachandran Jayakumar

deva@icuconsultants.com

2021-03-25

Not recruiting

RCT

Randomized

Factorial

Open label

single-center

Treatment

1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with <br/ > a. symptoms or signs or both that are <br/ > consistent with lower respiratory tract <br/ > infection (for example, acute onset of <br/ > dyspnea, cough, pleuritic chest pain) AND <br/ > b. Radiological evidence of new onset <br/ > infiltrate of infective origin (in patients <br/ > with preexisting radiological changes, <br/ > evidence of new infiltrate) <br/ >2. Up to 48 hours after ICU admission, receiving organ support with one or more of: <br/ > a. Non-invasive or invasive ventilatory <br/ > support <br/ > b. Receiving infusion of vasopressor or <br/ > inotropes or both

1. Healthcare-associated pneumonia: <br/ > a. Prior to this illness, is known to have <br/ > been an inpatient in any healthcare <br/ > facility within the last 30 days <br/ > b. Resident of a nursing home or long-term <br/ > care facility. <br/ >2. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment. <br/ >3. Previous participation in this REMAP within the last 90 days <br/ >4. Clinical or laboratory bleeding risk or both that is sufficient to contraindicate therapeutic anticoagulation, including intention to continue or commence dual anti-platelet therapy <br/ >5. Therapeutic anticoagulation is already present due to prior administration of any anticoagulant agent that is known or likely to still be active or a clinical decision has been made to commence therapeutic anticoagulation <br/ >6. Enrolment in a trial evaluating anticoagulation for proven or suspected COVID19 infection, where the protocol of that trial requires continuation of the treatment assignment specified in that trial <br/ >7. Known or suspected previous adverse reaction to UFH or LMWH including heparin induced thrombocytopenia (HIT).

2

Monash University

18

90

India

Severe/critical disease at enrollment

7: Severe/critical disease at enrollment

200

all cause mortality at 90 daysTimepoint: 90 days

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "1mg/kg", "treatment_id": 465, "treatment_name": "Enoxaparin sodium", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "40mg", "treatment_id": 465, "treatment_name": "Enoxaparin sodium", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}]