COVID-19: addition of azithromycin to chloroquine treatment

INTERVENTION: Product Name: chloroquine Product Code: RVG 106659 Pharmaceutical Form: Tablet Product Name: azithromycin Product Code: RVG 117670 Pharmaceutical Form: Tablet CONDITION: COVID‐19 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: Does addition of azithromycin to standard chloroquine treatment result in a higher clinical cure rate at day 7 than treatment with chloroquine alone in patients with COVID‐19.; ; Cure is considered when 4 criteria are present:; (1) O2 sat > 94% with room air; (2) 24 hours without fever (=38°C) ; (3) Breathing frequency < 24/min; Primary end point(s): The initial response to treatment will be evaluated during admission. ; Cure is considered when 3 criteria are present:; (1) O2 sat > 94% with room air; (2) 24 hours without fever (=38°C) ; (3) Breathing frequency < 24/min; ; The percentage of patients with clinical cure at day 7 will be calculated; Secondary Objective: Does addition of azithromycin to standard chloroquine treatment result in a higher viral clearance rate at day 7 confirmed by a negative COVID‐19 PCR than treatment with chloroquine alone in patients with COVID‐19. Timepoint(s) of evaluation of this end point: days of admission to day of discharge; primary endpoint will be determined at day 7 SECONDARY OUTCOME: Secondary end point(s): • Does addition of azithromycin to standard chloroquine treatment result in a higher viral clearance rate at day 7 confirmed by a negative COVID‐19 PCR than treatment with chloroquine alone in patients with COVID‐19.; • Day of normalisation of lymphocyte count ; ; • Time of clinical cure (days); ; • Length of stay; ; • Number of ICU admissions; ; • Mortality; ; • Adverse events; ; • CRP course; Timepoint(s) of evaluation of this end point: days of admission to day of discharge; secondary endpoint will be determined at day 7 INCLUSION CRITERIA: • Proven diagnosis of COVID‐19 by positive PCR in any specimen < 48 hours prior to randomization. • Age = 18 year • Hospitalized patients with illness of any duration, and SpO2 = 94% on room air 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30