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Associated lung condition in viral infectio

Phase 3
Conditions
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: J188- Other pneumonia, unspecified organism
Registration Number
CTRI/2021/03/032293
Lead Sponsor
Monash University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
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

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).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
all cause mortality at 90 daysTimepoint: 90 days
Secondary Outcome Measures
NameTimeMethod
Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinically indicated testing) <br/ ><br>Confirmed deep venous thrombosis <br/ ><br>Confirmed pulmonary embolism <br/ ><br>Total red cell blood cell units transfused between randomization and the end of study day 15 <br/ ><br>Serious adverse eventsTimepoint: 90 days
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