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

• ClinicalTrials.gov Identifier: NCT04794998
• Recruitment Status: Completed
• First Posted: March 12, 2021
• Last Update Posted: October 6, 2021
• Sponsor: Mario Negri Institute for Pharmacological Research
• 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
• 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

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

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