Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: J188- Other pneumonia, unspecified organism
Conditions
Interventions
Intervention1: Enoxaparin 40mg: Enoxaparin 40mg SC OD or equivalent dose of unfractionated heparin
Intervention2: Enoxaparin 1mg/kg: Enoxaparin 1mg/kg SC twice daily or unfractionated heparin infusion
Sponsors
Monash University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with a. symptoms or signs or both that are consistent with lower respiratory tract infection (for example, acute onset of dyspnea, cough, pleuritic chest pain) AND b. Radiological evidence of new onset infiltrate of infective origin (in patients with preexisting radiological changes, evidence of new infiltrate) 2. Up to 48 hours after ICU admission, receiving organ support with one or more of: a. Non-invasive or invasive ventilatory support b. Receiving infusion of vasopressor or inotropes or both
Exclusion criteria
Exclusion criteria: 1. Healthcare-associated pneumonia: a. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days b. Resident of a nursing home or long-term care facility. 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. 3. Previous participation in this REMAP within the last 90 days 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 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 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 7. Known or suspected previous adverse reaction to UFH or LMWH including heparin induced thrombocytopenia (HIT).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| all cause mortality at 90 daysTimepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinically indicated testing) Confirmed deep venous thrombosis Confirmed pulmonary embolism Total red cell blood cell units transfused between randomization and the end of study day 15 Serious adverse eventsTimepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Devachandran Jayakumar
Apollo Speciality Hospitals
Outcome results
None listed