Early Outpatient Treatment of COVID-19: A Retrospective Analysis of 392 Cases in Italy

  1. Marco Cosentino
  2. Veronica Vernocchi
  3. Stefano Martini
  4. Franca Marino
  5. Barbara Allasino
  6. Maria Antonietta Bàlzola
  7. Fabio Burigana
  8. Alberto Dallari
  9. Carlo Servo Florio Pagano
  10. Antonio Palma
  11. Mauro Rango
  12. on behalf of IppocrateOrg Association Working Group for the Early Outpatient Treatment of COVID-19

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Abstract

COVID-19 was declared a pandemic in March 2020. The knowledge of COVID-19 pathophysiology soon provided a strong rationale for the early use of both anti-inflammatory and antithrombotic drugs; however, its evidence was slowly and partially incorporated into institutional guidelines. The unmet needs of COVID-19 outpatients were taken care of by networks of physicians and researchers. We analyse the characteristics, management and outcomes in COVID-19 outpatients who were taken care of by physicians within the IppocrateOrg Association. In this observational retrospective study, volunteering doctors provided data on 392 COVID-19 patients. The mean age of patients was 48.5 years (range: 0.5–97), and patients were taken care of in COVID-19 stage 0 (15.6%), stage 1 (50.0%), stage 2a (28.8%) and stage 2b (5.6%). Many patients were overweight (26%) or obese (11.5%), with chronic comorbidities (34.9%), mainly cardiovascular (23%) and metabolic (13.3%). The most frequently prescribed drugs included: vitamins and supplements (98.7%), aspirin (66.1%), antibiotics (62%), glucocorticoids (41.8%), hydroxychloroquine (29.6%), enoxaparin (28.6%), colchicine (8.9%), oxygen therapy (6.9%), and ivermectin (2.8%). Hospitalization occurred in 5.8% of cases, mainly in stage 2b (27.3%). A total of 390 patients (99.6%) recovered; one patient was lost at follow up, and one patient died after hospitalization. This is the first real-world study describing the behaviours of physicians caring for COVID-19 outpatients, and the outcomes of COVID-19 early treatment. The lethality in this cohort was 0.2%, while overall, and over the same period, the COVID-19 lethality in Italy was over 3%. The drug use described in this study appears effective and safe. The present evidence should be carefully considered by physicians and political decision makers.

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  1. Version published to 10.3390/jcm11206138
  2. ScreenIT

    SciScore for 10.1101/2022.04.04.22273356: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our study has many methodological limitations which we are well aware of. The main limitation is the retrospective design. Physicians were asked to provide data about patients taken care of during an emergency situation, when each of them volunteered with the overarching goal to care for patients in need and save lives. For this reason, collected data include only essential information to get an overall picture of COVID-19 patients’ clinical profile and outcomes. Much more information is needed however to describe in detail the clinical course of COVID-19 and its response to drug treatments, such as: time to recovery, drug doses and time of administration, the nature, duration and outcomes of any post-recovery sequelae, reasons for hospitalization and treatments received in hospital, etc. In addition, we lack any kind of control group, therefore results could be compared only and very cautiously with whole population official Italian data referring to about the same time periods and concerning COVID-19 lethality, but not directly compared according to age range and sex, or for different outcomes, e.g. admission to hospital. Finally, a small sample of doctors (10) took part in this first study, and nevertheless they were able to collect data about nearly 400 patients, which represents so far the largest sample of COVID-19 patients thoroughly investigated in Italy. All the participating doctors included only consecutive patients thus minimizing any possible selection bias. In c...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2022.04.04.22273356v1 on medRxiv