Material and Methods:
Design: This was a single-centre, prospective, randomised
controlled cohort study. This study was conducted in the Health Sciences
University Kanuni Sultan Suleyman Training and Research Hospital, which
was designated as a pandemic hospital. The Ministry of Health and local
ethics committee approved the study (Ethics Committee approval number:
KAEK/2020.05.50).
Participants: Between March 7 and July 8, 2020, adults who were
hospitalised in the pandemic ward with the diagnosis of COVID-19
included upon individual informed written consent. All participants
evaluated with a nasopharyngeal swab polymerase chain reaction (PCR) and
chest computed tomography (CCT). The treatment protocol recommended by
the Ministry of Health was applied for all cases. The recommended
treatment regimen is hydroxychloroquine, 400 mg daily for another 5
days, and/or favipiravir, 2 x 600 mg for 4 days following a 2 x 1600 mg
loading dose on day one. QCB (1000 mg quercetin, 1000 mg vitamin C and
100 mg bromelain) supplementation was added daily in 2 divided doses to
52/447 patients with at least one chronic disease and moderate-to-severe
respiratory symptoms. Computer-generated random numbers used for simple
randomisation. Exclusion criteria determined as severe respiratory
failure, shock and/or combined failure of other organs that required ICU
monitoring and treatment; previous history of allergic reactions against
any component of QCB; pregnant or lactating women; women of childbearing
age with a positive pregnancy test, breastfeeding, miscarriage, or
within 2 weeks after delivery; and participation in another clinical
trial against SARS-CoV-2 treatment currently or in the past 28 days.
The study was reported according to the Consolidated Standards of
Reporting Trials guidelines and registered on ClinicalTrials.gov
(number: NCT04377789) on March 20, 2020. The primary endpoint of the
study was determined as QCB supplementation was continued throughout the
follow-up period from study baseline to discharge, intubation, or death.
Demographic features, vital signs, laboratory test results during
follow-up, drug administration data, past and current diagnoses of the
patients were recorded. CCT findings of the cases were evaluated in 5
stages: stage 0 is the lung being completely normal, stage 1; light
one-sided ground glass image, stage 2; multifocal double-sided ground
glass image, stage 3; multifocal bilateral ground glass and stage 4;
opacity, air bronchogram, bilateral ground glass and opacity,
respectively.