Clinical trial NCT04575064: An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY
Official title: An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care - WHO-SOLIDARITY-GERMANY
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: SARS-CoV-2 Infection
COVID-19
Moderate and Severe COVID-19
Lead sponsor: Klinikum Bremen-Mitte, gGmbH
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: World Health Organization
First posted: 2020-10-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years and older
* Current SARS-CoV-2 infection
* Admitted to the hospital ward or the ICU due to COVID-19
* SpO2 \<= 94% on room air OR oxygen demand OR breathing support
* Written informed consent obtained

Exclusion Criteria:

* Patient's non-consent or inability to informed consent
* Pregnant or breastfeeding women.
* Subjects pretreated with one of the study drugs in the past 29 days
* Anticipated transfer within 72 hours to a non-study hospital
* Severe co-morbidity with life expectancy \< 3 months
* AST or ALT \> 5 times the upper limit of normal
* Stage 4 severe chronic kidney disease or requiring dialysis
* Contraindications and known intolerance to any of the study drugs
* Subjects participating in a potentially confounding drug or device trial
* Any reason why the patient should not participate (investigator's opinion)

Primary outcomes:
measure: Improvement of clinical status on the ordinal 7-point severity-scale at day 15.
timeFrame: at day 15
Secondary outcomes:
measure: Time to an improvement of one category from admission using the 7-point ordinal scale
timeFrame: up to 29 days
measure: Mortality: 28 days mortality; in-house mortality
timeFrame: up to 29 days
measure: Hospital stay: Duration of hospital stay due to COVID-19
timeFrame: up to 29 days
measure: Oxygen: Need of, time to first receiving and duration of oxygen
timeFrame: up to 29 days
measure: Intensive care: Need of, time to first receiving and duration of intensive care
timeFrame: up to 29 days
measure: Mechanical ventilation: Need of, time to first receiving and duration of mechanical ventilation
timeFrame: up to 29 days
measure: ECMO: Need of, time to first receiving and duration for extracorporeal membrane oxygenation
timeFrame: up to 29 days
measure: Superinfections, assessed with pathogen testing
timeFrame: up to 29 days
measure: Kidney failure
timeFrame: up to 29 days
measure: Myocardial failure
timeFrame: up to 29 days
measure: Multiple organ failure
timeFrame: up to 29 days
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Gesundheit Nord gGmbH
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
city: München
country: Germany
facility: Technische Universität München (TUM)
Study officials:
affiliation: Hannover Medical School
name: Tobias Welte, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: