Spain Study: A short therapeutic regimen based on hydroxychloroquine plus azithromycin for the treatment of COVID-19 in patients with non-severe disease. A strategy associated with a reduction in hospital admissions and complications.

Source: medRxiv

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.


Oligosymptomatic 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.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

We think that our study was misunderstood. This is not a clinical trial. It is an observational study with an intervention that was approved by the Direction of the Hospital. In Spain this treatment was an authorized option with or without a clinical trial.

Funding Statement

No external funding was received.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This is not a clinical trial. It is an observational study with an intervention approved by the Direction of the Hospital. At the moment of the study (beginning of April, during the lockdown in Spain), this study was an authorized option in Spain, with or without a clinical trial.

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Related:

Denmark: Chloroquine, but not hydroxychloroquine, prolongs the QT interval in a primary care population

Outcomes of 3,737 COVID-19 patients treated with hydroxychloroquine/ azithromycin and other regimens in Marseille, France: A retrospective analysis

India: HCQ beneficial as preventive drug: SMS doctors told ICMR

Efficacy and safety of chloroquine or hydroxychloroquine in moderate type of COVID-19: a prospective open-label randomized controlled study

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