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A Simple Approach to Treat COVID-19 Patients at Home. (COVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04794998
Recruitment Status : Completed
First Posted : March 12, 2021
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Tracking Information
First Submitted Date March 10, 2021
First Posted Date March 12, 2021
Last Update Posted Date October 6, 2021
Actual Study Start Date February 8, 2021
Actual Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 11, 2021)
Time to complete remission [ Time Frame: From beginning the proposed recommended treatments or other therapeutic regimens to resolution of major symptoms, assessed up to 20 days. ]
"Complete remission" is defined as complete recovery from major symptoms, ie no fever, SpO2 >94% and/or no dyspnea, no cough, no rhinitis, no pain (myalgia, arthralgia, chest pain, headache, sore throat), no vertigo, no nausea, vomiting or diarrhoea, no sicca syndrome or red eyes.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Simple Approach to Treat COVID-19 Patients at Home.
Official Title A Simple Approach to Treat COVID-19 Patients at Home: Does it Reduce Recovery Time? A Retrospective Observational Matched-cohort Study
Brief Summary

The newly recognised disease COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which by early December 2019 had spread from China to the rest of the world, especially Europe, the United States, Latin America, and India, with over 86 million confirmed cases and over 1.870.000 deaths (5th January, 2021). The clinical spectrum of SARSCoV- 2 infection is wide, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and even death.

According to retrospective data from China regarding 1099 patients with laboratory-confirmed COVID-19, at the time of admission to hospital, the most common symptoms were cough (67.8%), fever (43%), and fatigue (38.1%), and less frequently myalgia/arthralgia (14.9%), a sore throat (13.9%) and headache (13.6), while nausea or vomiting (5.0%) and diarrhoea (3.8%) were uncommon. Similar clinical characteristics are also encountered in European and US COVID-19 patients.

Given the rising global death toll associated with the pandemic, in the past few months we have witnessed a race to find drug/biological treatments to save the lives of hospitalized, severely ill patients, as well as to develop vaccines. To this end, randomized clinical trials are underway to test experimental drug candidates, or repurposed medicines. At this time, it is crucial to focus on primary care physicians and initial mild symptoms at home in COVID-19 patients.

Recently recommendations have been produced to treat this illness at home based on the pathophysiologic and the pharmacologic rationale and the available clinical evidence of efficacy in COVID-19 patients, including results of published clinical trials, for each of the recommended class of drugs. These recommendations have taken advantage from the long term experience of an infection disease specialist and other clinicians of Bergamo Hospital, who used their know-how and sound judgment to treat COVID-19 patients at home.

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.

Moreover, COVID-19 is a particularly debilitating illness, and, apart from causing patients to be bedridden, there is evidence that in SARS-CoV-2 infection, dysregulation of the coagulation cascade and fibrinolytic system occur. Therefore, COVID-19 patients are exposed to the risk of thromboembolic events, independently of age, and anticoagulant prophylaxis is recommended, unless contraindicated.

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 novel therapies. Thus, we will use this approach in an observational retrospective matched-cohort study to compare a cohort of COVID-19 patients treated at home by their family phisicians according to the proposed recommendations with another cohort of similar patients treated with other therapeutic regimens.

Our working hypothesis is that following the recommendations the inflammatory processes and thus symptoms resolve faster than with other therapeutic approaches, while safe achieving similar rates of complete remission of the illness.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population COVID-19 patients treated at home by their family doctors according to the proposed recommendations from May 2020 to November 2020. It will include all available family physicians who have followed these recommendations and expressed interest in the study.
Condition COVID 19
Intervention
  • Drug: Recommended treatment schedule
    Relatively selective Cox-2 inhibitors, Corticosteroids (Dexamethasone), Anticoagulants (LMW heparin), Gentle Oxygen therapy
  • Drug: Control treatment schedule
    Treatment regimens different from the recommended one according to family phisicians personal practice.
Study Groups/Cohorts
  • "Recommended schedule" cohort
    COVID-19 patients who have applied the proposed treatment recommendation algorithm at the onset of or within few days from the beginning of symptoms.
    Intervention: Drug: Recommended treatment schedule
  • "control" cohort
    COVID-19 patients enrolled in the ORIGIN study of the Istituto di Ricerche Farmacologiche Mario Negri IRCCS, and treated at home by their family doctors with drug regimens other than those proposed in the recommendations
    Intervention: Drug: Control treatment schedule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 5, 2021)
180
Original Estimated Enrollment
 (submitted: March 11, 2021)
216
Actual Study Completion Date July 31, 2021
Actual Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who require immediate hospital admission because severe COVID-19 symptoms at onset according to family doctor opinion
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04794998
Other Study ID Numbers COVER
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Mario Negri Institute for Pharmacological Research
Original Responsible Party Same as current
Current Study Sponsor Mario Negri Institute for Pharmacological Research
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Mario Negri Institute for Pharmacological Research
Verification Date October 2021