Abstract: medRxiv preprint doi: https://doi.org/10.1101/2020.06.10.20101105; this version posted June 12, 2020. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
TITLE: A short therapeutic regimen based on hydroxychloroquine plus
azithromycin for the treatment of COVID-19 in patients with moderate disease. A
strategy associated with a reduction in hospital admissions and complications.
AUTHORS: José A. Oteo (1), Pedro Marco (2), Luis Ponce de León (3), Alejandra
Roncero (3), Teófilo Lobera (3), Valentín Lisa (2).
(1) Infectious Disease Department. Hospital Universitario San Pedro and Center of
Biomedical Research of La Rioja (CIBIR). Piqueras 98. 26006 Logroño (Spain)
(2) Emergency Department. Hospital Universitario San Pedro. Piqueras 98. 26006
Logroño (Spain)
(3) Hospital Home-Care Unit. Piqueras 98. 26006 Logroño (Spain)
Conflict of interest disclosure: Nothing to disclose.
Funding: No external funding was received.
Word count: 2,354
Author contributions:
JAO, PM and VL conceived the study; LP, AR and TL supervised the data collection;
JAO and PM drafted the manuscript, and all authors contributed substantially to its
revision. JAO takes responsibility for the paper as a whole.
Corresponding Author:
José A. Oteo, M.D; PhD
Department of Infectious Diseases
Hospital Universitario San Pedro – Centro de Investigación Biomédica de La Rioja
C/Piqueras 98. 26006 Logroño (Spain)
jaoteo@riojasalud.es
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
medRxiv preprint doi: https://doi.org/10.1101/2020.06.10.20101105; this version posted June 12, 2020. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
SUMMARY
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 Logroño (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..
DOI record:
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"abstract": "<jats:title>SUMMARY</jats:title><jats:p>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.</jats:p><jats:sec><jats:title>Patients and methods</jats:title><jats:p>Patients ≥ 18 years old visiting the emergency room at the Hospital Universitario San Pedro de Logroño (La Rioja) between March, 31<jats:sup>st</jats:sup>and April, 12<jats:sup>th</jats:sup>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.</jats:p><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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).</jats:p><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>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.</jats:p></jats:sec>",
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