Last updated: December 14, 2021
Sponsor: University Hospital, Montpellier
Overall Status: Terminated
Phase
2/3
Condition
Pneumonia
Common Cold
Respiratory Syncytial Virus (Rsv) Infection
Treatment
N/AClinical Study ID
NCT04345861
RECHMPL20_168
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18-75 years old SARS CoV-2 Infection confirmed by positive virologic test realised inthe 96 h before randomization
- Beginning of COVID-19 symptoms < 10 days at the time of randomization
- Presence of symptom(s) of COVID-19 : fever (température > or = 37,5°C) or respiratorysign(s) (cough, breathing discomfort) or recent anosmia
- Presence of TDM/radiographic signs or pneumonia
- Hospitalization out of ICU for COVID with: moderate clinical form (no oxygenotherapy)or non critical severe form (oxygenotherapy)
Exclusion
Exclusion Criteria:
- Absence of signed informed consent
- SpO2 < 90 % ambient air or < 94 % with oxygenotherapy > or = 3l/min
- Need of oxygenotherapy > 6 l/min or mechanical ventilation
- Need of hospitalization in ICU
- ALAT/ASAT > 5 LSN
- Renal failure (eGFR < 40 ml/min ) or dialysis
- Pregnancy or breastfeeding
- Retinopathy
- Known deficit in G6PD
- Cardiac rythm / lengthening QT disorders
- QT space lengthening on ECG with QTc > 450 ms
- Concomitant treatment :citalopram, escitalopram, hydroxyzine, domperidone,pipéraquine, anti-arhythmic class IA & III, antidepressive drugs,..
Study Design
Total Participants: 7
Study Start date:
April 11, 2020
Estimated Completion Date:
April 09, 2021
Study Description
Connect with a study center
Montpellier University hospital
Montpellier, 34295
FranceSite Not Available

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