José A. Oteo, Pedro Marco, Luis Ponce de León, Alejandra Roncero, Teófilo Lobera, Valentín Lisa
Abstract
The new SARS-CoV-2 infection named COVID-19 has severely hit
our Health System. At the time of writing this paper no medical therapy
is officially recommended or has shown results in improving the
outcomes in COVID-19 patients. With the aim of diminishing the impact in
Hospital admissions and reducing the number of medical complications,
we implemented a strategy based on a Hospital Home-Care Unit (HHCU)
using an easy-to-use treatment based on an oral administration regimen
outside the hospital with hydroxychloroquine (HCQ) plus azithromycin
(AZM) for a short period of 5 days. Patients and methods: Patients ≥ 18
years old visiting the emergency room at the Hospital Universitario San
Pedro de Logrono (La Rioja) between March, 31st and April, 12th
diagnosed with COVID-19 with confirmed SARS-CoV-2 infection by a
specific PCR, as follows: Patients with pneumonia (CURB ≤ 1) who did not
present severe comorbidities and had no processes that contraindicated
this therapeutic regime. Olygosimptomatic patients without pneumonia
aged ≥ 55 years. Patients ≥ 18 years old without pneumonia with
significant comorbidities. We excluded patients with known allergies to
some of the antimicrobials used and patients treated with other drugs
that increase the QTc or with QTc >450msc. The therapeutic regime
was: HCQ 400 mg every twice in a loading dose followed by 200 mg twice
for 5 days, plus AZM 500 mg on the first day followed by 250 mg daily
for 5 days. A daily telephone follow-up was carried out from the
hospital by the same physician. The end-points of our study were: 1.- To
measure the need for hospital admission within 15 days after the start
of treatment. 2.- To measure the need to be admitted to the intensive
care unit (ICU) within 15 days after the start of the treatment. 3.- To
describe the severity of the clinical complications developed. 4.- To
measure the mortality within 30 days after starting treatment
(differentiating if the cause is COVID-19 or something else). 5.-To
describe the safety and adverse effects of the therapeutic regime.
Results: During the 13 days studied a total of 502 patients were
attended in the emergency room due to COVID-19. Forty-two were sent at
home; 80 were attended by the HHCU (patients on this study) and 380 were
admitted to the Hospital. In our series there were a group of 69
(85.18%) patients diagnosed with pneumonia (37 males and 32 females).
Most of them, 57 (82.60%) had a CURB65 score of <1 (average age 49)
and 12 (17.40%) a CURB score of 1 (average age 63). Eighteen (22.50%) of
the pneumonia patients also had some morbidity as a risk factor. 11
patients (13.75%) without pneumonia were admitted to the HHCU because
comorbidities or age ≥ 55 years. Six patients with pneumonia had to be
hospitalized during the observation period, 3 of them because side
effects and 3 because of worsening. One of these patients, with morbid
obesity and asthma, had clinical worsening needing mechanical
ventilation at ICU and developed acute distress respiratory syndrome.
With the exception of the patient admitted to the ICU, the rest of the
patients were discharged at home in the following 8 days (3 to 8 days).
Twelve patients (15%), 11 of whom had pneumonia, experienced side
effects affecting mainly the digestive. In another patient a QTc
interval prolongation (452 msc) was observed. In total 3 of these
patients had to be admitted in the Hospital, 2 because of vomiting and 1
because a QTc interval lengthening. None of the patients needed to stop
the HCQ or AZM and all the 80 patients finished the therapeutic
strategy. From the group without pneumonia only a patient developed
diarrhea that did not require hospitalization or stop the medication.
Conclusions: Our strategy has been associated with a reduction in the
burden of hospital pressure, and it seems to be successful in terms of
the number of patients who have developed serious complications and / or
death. None of the patients died in the studied period and only 6 have
to be admitted in conventional hospitalization area.
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https://www.medrxiv.org/content/10.1101/2020.06.10.20101105v1