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.
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.
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 group | Role | What they receive |
|---|---|---|
| 'Recommended algorithm' cohort | COVID-19 patients treated at home by their family doctors according to the proposed recommendations Receives: Drug: Recommended treatment schedule | |
| '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 Receives: Drug: Control treatment schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted22 Apr 2021
- Study start1 Jul 2021
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simple, Home-treatment Algorithm to Prevent Hospitalization for COVID-19 Patients: A Matched -Cohort Study
- ClinicalTrials.gov ID
- NCT04854824
- Acronym / sponsor ID
- COVER2 / COVER 2
- Conditions
- Covid19
- Keywords
- COVID-19 treatment at home, Early symptoms, Hospitalization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'Recommended algorithm' cohort | – | Drug: Recommended treatment scheduleCOVID-19 patients treated at home by their family doctors according to the proposed recommendations |
| 'Historic control' cohort | – | Drug: Control treatment scheduleCOVID-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects of the two cohorts who require immediate hospital admission because of severe COVID-19 symptoms at onset according to family doctor's assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recommended treatment scheduleRelatively selective Cox-2 inhibitors, Corticosteroids (Dexamethasone), Anticoagulants (LMW heparin), Gentle oxygen therapy | Drug | 'Recommended algorithm' cohort |
| Control treatment scheduleTreatment regimens different from the recommended one according to family physician personal practice | Drug | 'Historic control' cohort |
Primary outcome
Proportion of patients who require hospitalization
Time frame: From beginning the proposed recommended treatments or other therapeutic regimens, assessed up to 60 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: PubMed 35530041Consolaro 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
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.