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Covid19COVER2NCT04854824

A Simple Approach to Prevent Hospitalization for COVID-19 Patients

An observational study of Covid19, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
What is being tested?
Recommended treatment schedule
How many people
216 participants
Where
2 sitesItaly
Study dates
1 Jul 2021to 21 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites
  • ASL Teramo

    Teramo, TE, 64100

  • ATS Insubria

    Varese, VA, 21100

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Conditions
Covid19
Being tested
Recommended treatment schedule, Control treatment schedule
Keywords
COVID-19 treatment at home, Early symptoms, Hospitalization
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recommended treatment scheduleDrug

    Relatively selective Cox-2 inhibitors, Corticosteroids (Dexamethasone), Anticoagulants (LMW heparin), Gentle oxygen therapy

  • Control treatment scheduleDrug

    Treatment regimens different from the recommended one according to family physician personal practice

Study groups in NCT04854824
Study groupRoleWhat they receive
'Recommended algorithm' cohortCOVID-19 patients treated at home by their family doctors according to the proposed recommendations
Receives: Drug: Recommended treatment schedule
'Historic control' cohortCOVID-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
Receives: Drug: Control treatment schedule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who require hospitalization

    Measured: From beginning the proposed recommended treatments or other therapeutic regimens, assessed up to 60 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start1 Jul 2021
  3. Primary completion21 Dec 2021
  4. Study completion21 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04854824
Sponsor's protocol ID
COVER 2
Acronym
COVER2
Status last verified
Mar 2023
First submitted
21 Apr 2021
Last updated
21 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Consolaro E, Suter F, Rubis N, Pedroni S, Moroni C, Pasto E, Paganini MV, Pravettoni G, Cantarelli U, Perico N, Perna A, Peracchi T, Ruggenenti P, Remuzzi G. A Home-Treatment Algorithm Based on Anti-inflammatory Drugs to Prevent Hospitalization of Patients With Early COVID-19: A Matched-Cohort Study (COVER 2). Front Med (Lausanne). 2022 Apr 22;9:785785. doi: 10.3389/fmed.2022.785785. eCollection 2022.

    PubMed 35530041

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who require hospitalization (time frame: From beginning the proposed recommended treatments or other therapeutic regimens, assessed up to 60 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04854824, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

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