Coronavirus Response - Active Support for Hospitalised COVID-19 patients

Phase 3

• Conditions: COVID-19

• Registration Number: PACTR202006473370201
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-12
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

Adults age 40 years and older
with suspected or confirmed acute COVID-19 infection (We use the following WHO criteria for a suspected case: A. A patient with acute respiratory illness (fever and at least one sign or symptom of respiratory disease, e.g., cough, shortness of breath), AND a history of travel to or residence in a location reporting community transmission of COVID-19 disease during the 14 days prior to symptom onset; OR B. A patient with any acute respiratory illness AND having been in contact with a confirmed or probable COVID-19 case in the last 14 days prior to symptom onset; OR C. A patient with severe acute respiratory illness (fever and at least one sign/symptom of respiratory disease, e.g., cough, shortness of breath; AND requiring hospitalization) AND in the absence of an alternative diagnosis that fully explains the clinical presentation.)
requiring hospitalisation

Exclusion Criteria

Women known to be pregnant
Patients hospitalised without symptoms of acute COVID-19 infection should not be recruited even if they test positive for COVID-19
Patients already receiving mechanical ventilation via an endotracheal tube
Patients already receiving any of the trial treatments
Patients with a definite indication or contraindication for any of the trial treatments.
Patients who are very severely frail (completely dependent and approaching end of life who typically they could not recover even from a mild illness) or terminally ill should not be recruited.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hopsital death. Cause of death will be described

Secondary Outcome Measures

Name	Time	Method
myocardial infarction, cardiac failure, severe cardiac arrhythmia, myocarditis, respiratory failure including ARDS, viral pneumonitis, acute renal failure, sepsis, stroke, gastrointestinal bleeding, receipt of non-invasive or mechanical ventilation requiring endotracheal intubation, ability to self-care at hospital discharge and time to hospital discharge.