COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04920838

Olivier Marcy, Dr

olivier.marcy@u-bordeaux.fr

2021-06-10

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: adults 18 years of age at the time of screening or >= 40 years and presenting at least one comorbidity : high blood pressure; a known obesity and/ or a known and treated diabete. sars-cov-2 infection confirmed by molecular biology (rt-pcr on a nasopharyngeal or oropharyngeal swab) or by antigen test validated in the country according to national guidelines a viral syndrome with or without uncomplicated pneumonia, defined as blood oxygen saturation level (spo2) >=94%. mild covid-19 symptoms with an onset < 7 days before inclusion. signed written consent from the patient or his/her representative. no need an oxygen therapy according to international guidelines (who progression scale, grade 2 to 4) accepting and having the ability to be reached by telephone throughout the study. having designated a contact person who can be contacted in case of emergency. accepted to be reached by phone along throughout the study

blood oxygen saturation level (spo2) < 94%. known hypersensitivity to investigational products chronic treatment with inhaled corticosteroids (up to 30 days) known history of renal or hepatic failure abnormal physical examination findings: respiratory rate < 25 per minute; clinical hypotension with associated signs justifying hospital care feeling unwell for more than 7 days prior to screening. end-organ compromise requiring admission to a resuscitation or continuous care unit or short-term life-threatening comorbidity with life expectancy < 3 months. for any new antiviral included in the study, prior treatment with the antiviral, presence of contraindication to its use or intake of concomitant medication proscribed with its use. patients with known suicidal thoughts, severe psychiatric disorders or major depression that is uncontrolled or controlled by one of the prohibited drugs known history of long qt syndrome or severe ventricular cardiac arrhythmia (ventricular tachycardia, patients with recovered ventricular fibrillation) unwilling or unable to comply with the requirements of the study protocol at any time during the study, e.g. no access to or not comfortable with use of a smartphone or with answering questions using a telephone, in the opinion of the investigator or cannot use an inhalation chamber. any other reason that makes it impossible to monitor the patient during the study. enrolled in other clinical trials with unregistered drugs or with registered drugs that may interact with any of the study ips or are contraindicated as concomitant therapy within the last 3 months prior to screening

4

ANRS, Emerging Infectious Diseases

18

100

Burkina Faso;Guinea

Mild disease at enrollment

1: Mild disease at enrollment

600

Death within 14 days;SpO2 ≤ 93% within 14 days

None

Phase 2/Phase 3

[{"arm_notes": "nan", "treatment_id": 2515, "treatment_name": "Budesonide+fluoxetine", "treatment_type": "Corticosteroids+central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1650, "treatment_name": "Ciclesonide+nitazoxanide", "treatment_type": "Corticosteroids+antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 958, "treatment_name": "Paracetamol", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1274, "treatment_name": "Telmisartan", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}]