A Simple Approach to Prevent Hospitalization for COVID-19 Patients (COVER2)

March 20, 2023 updated by: Mario Negri Institute for Pharmacological Research

A Simple, Home-treatment Algorithm to Prevent Hospitalization for COVID-19 Patients: A Matched -Cohort Study

The newly recognised disease COVID-19 is caused by the Severe-Acute-Respiratory-Syndrome Coronavirus 2 (SARS-CoV-2), which rapidly spread globally in late 2019, reaching pandemic proportions. The clinical spectrum of SARS-CoV-2 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness and mild extrapulmonary symptoms, and severe viral pneumonia with respiratory failure and even death.

Given the rising global death toll associated with the pandemic, in the last year we have witnessed a race to find drugs/biological treatments to save the lives of hospitalised, severely ill patients, as well as to develop vaccines. Nonetheless, to limit the number of hospitalisations and deaths due to severe illness, thus avoiding pushing hospitals to their limits and remarkably reducing the tremendous treatment costs for health care providers, it is crucial to also focus on primary care physicians and initial mild symptoms in COVID-19 patients at home.

As with other acute viral infections, early initiation of treatment for COVID-19 might improve clinical outcomes.

For COVID-19, most primary care physicians have initially treated their patients according to their judgment, with various treatment regimens they believe are most appropriate based on thier experience/expertise. We recently published a note on how we were treating patients at home based on the pathophysiologic and pharmacologic rationale and the available clinical evidence of efficacy in COVID-19 for each of the recommended class of drugs.

Because the common early mild symptoms of COVID-19 highlight a systemic inflammatory process, there is the recommendation of using anti-inflammatory agents to limit excessive host inflammatory responses to the viral infection, including non-steroidal anti-inflammatory drugs and corticosteroids.

In a recent academic matched-cohort study, we found that early treatment of COVID-19 patients at home by their family doctors according to the proposed recommendation regimen almost completely prevented the need for hospital admission (the most clinically relevant outcome) due to progression toward more severe illness, compared to patients in the 'control' cohort who were treated at home according to their family physician's assessments. This translated into a reduction of over 90% in the overall numbers of days of hospitalisation and in related treatment costs. Treatment according to the recommended algorithm was safe and well tolerated. However, the rate of hospitalization was a secondary outcome of the study and the possibility of a casual finding cannot be definitely excluded. Thus, we have considered the observed reduction in patient hospitalization an hypothesis generating finding that provides a robust background for the present new cohort study primarily aimed to test the effect on this outcome of COVID-19 treatment at home according to the proposed recommendation algorithm.

No randomized clinical trials have been performed so far in COVID-19 patients to compare the effectiveness of different regimens targeting early symptoms at home. Comparative analysis of patient cohorts with long-enough follow-up in everyday clinical practice may offer a good alternative to randomized clinical trials to evaluate effectiveness of therapeutic interventions. Thus, we will use this approach to compare a cohort of COVID-19 patients treated at home by their family physicians according to the proposed recommendation algorithm with another cohort of similar COVID-19 patients treated by their family doctors with various treatment regimens they believe most appropriate based on their experience and expertise, and monitored longitudinally up to 3 months.

Our working hypothesis is that following the proposed recommendation algorithm the early COVID-19-related inflammatory process is limited, preventing the need of hospital admission at larger extent than with other therapeutic approaches also targeting early symptoms of the illness at home.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • TE
      • Teramo, TE, Italy, 64100
        • ASL Teramo
    • VA
      • Varese, VA, Italy, 21100
        • ATS Insubria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

"Recommended algorithm" cohort COVID-19 patients treated at home by their family doctors according to the proposed recommendations from 1 January 2021 to 30 April 2021. It will include all available family physicians in the Bergamo, Varese and Teramo provinces who have followed the recommendation algorithm and expressed interest in participating in the study.

"Historic control" cohort Historic COVID-19 patients enrolled in the ORIGIN study, treated at home by their family physicians with drug regimens not necessarily guided by those proposed in the recommendations.

Description

Inclusion Criteria:

  • Male and female adult (≥18 years old)
  • Subjects with early mild symptoms of COVID-19, who start the treatment without waiting results of a nasopharyngeal swab, if any
  • Informed consent

Exclusion Criteria:

  • Subjects of the two cohorts who require immediate hospital admission because of severe COVID-19 symptoms at onset according to family doctor's assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
'Recommended algorithm' cohort
COVID-19 patients treated at home by their family doctors according to the proposed recommendations
Drug: Recommended treatment schedule
Relatively selective Cox-2 inhibitors, Corticosteroids (Dexamethasone), Anticoagulants (LMW heparin), Gentle oxygen therapy
'Historic control' cohort
COVID-19 patients enrolled in the ORIGIN study of the Istituto di Ricerche Farmacologiche Mario Negri IRCCS and treated at home by family physicians with drug regimens that are not necessarily guided by those proposed in the recommendations
Drug: Control treatment schedule
Treatment regimens different from the recommended one according to family physician personal practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients who require hospitalization
Time Frame: From beginning the proposed recommended treatments or other therapeutic regimens, assessed up to 60 days.
From beginning the proposed recommended treatments or other therapeutic regimens, assessed up to 60 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mario Negri Institute for Pharmacological Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 21, 2021

Study Completion (Actual)

December 21, 2021

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVER 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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