Azithromycin added to Hydrochloroquine in Patients Admitted to Intensive Care due to Coronavirus Disease 2019 (COVID-19) - Randomised Controlled Trial, phase III

Phase 1

• Conditions: Severe COVID-19; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001456-18-CZ
• Lead Sponsor: adacní fond Donatio intensivistam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-08
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1) adult (>18 years)
2) within 24 hours of admission to intensive care unit
3) proven or suspected COVID-19 infection
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

1) Symptoms of febrile disease for =1 week at enrolement
2) Pregnancy or inability/unwillingness to perform pregnancy test at and 28 days after enrolment
3) Treatment limitations in place or moribund patients
4) Allergy, intolerance or contraindication to any study drug, incl. long QT syndromes, myasthenia gravis, allergies or known deficiency of glucose-6-phosphate dehydrogenase
5) Known HIV positivity
6) Significant liver disease such as cirrhosis Child-Pugh C or active hepatitis B or C
7) Known stage IV chronic kidney disease, on dialysis at enrolment or imminent need of it
8) Participation in another outcome-based interventional trial within last 30 days
9) Patients taking Hydroxychloroquine for other indication than to treat COVID-19.

Criteria for withdrawal from the study:
1) Consent withdrawal by study subject
2) In case – in the opinion of the investigator – the study procedures are considered unsafe for the study subject or the risks outweigh the potential benefits

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary study objective is to test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival.;Secondary Objective: Secondary (exploratory) study objectives is to investigate, whether the intervention decreases viral load and influences oxygenation and mechanical feature of the lung. ;Primary end point(s): Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14.;Timepoint(s) of evaluation of this end point: 14 days after enrolment.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline.<br>ICU-LOS<br>D28 and D 90 mortality (in hospital);Timepoint(s) of evaluation of this end point: Day 14, 28 and 90 as defined above