Safe and Timely Cessation of Isolation of Patients With COVID-19 (The SCIP-COVID-19) Study

NCT05346042 | Active Not Recruiting

• 2 other identifiers: 11318910430102110003
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: In the treatment, care and isolation of COVID-19 patients, one of the most important issues is determining the duration of infectiousness. The current Dutch guideline advises at least 14 days of isolation for seriously ill patients, which is the case for most admitted patients, and at least 21 days for intubated patients. It is believed that in most cases this isolation duration is too long, which is highly undesirable for patients staying in closed single-occupancy rooms. This is known to result in limited contact with healthcare workers (HCW) and to be associated with a higher level of depression among patients. The longer the isolation, the higher the workload for HCW and the higher the costs (e.g. with about 0.5 million admission days in the Netherlands, these work out at about €14 million on personal protective equipment \[PPE\] and cleaning alone). Additionally, isolation demands a larger healthcare workforce, yielding less capacity to provide other care to non-COVID-19 patients, with numerous other consequences. On the other hand, it is possible that some patients were discontinued from isolation too early, leading to a risk of transmission to other patients and to HCW. In conclusion, duration of isolation should be as short as possible for proper patient flow and to avoid unnecessary burden to patients and HCW, and thus to healthcare in general. Therefore, there is an urgent need to define the period of infectiousness of COVID-19. We will develop a safe and effective algorithm for decision on timely discontinuation of isolation of COVID-19 hospitalized patients. Objective: The ultimate goal of this project is to produce new evidence-based criteria for the termination of isolation of hospitalized COVID-19 patients that are safe (very low subsequent risk of transmission to other patients or healthcare workers) while reducing the number of unnecessary days in isolation (thereby improving quality of life of patients, reducing hospital costs, and making optimal use of the scarce number of isolation beds). Multiple sources of data and evidence will be integrated to arrive at these new criteria.

Conditions

COVID-19

Keywords

COVID-19; infectiousness duration; isolation; infection prevention control measures

Outcome Measures

Primary Outcomes (1)

• the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation

  the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation

  Between the end of February 2020 and December 2021

Secondary Outcomes (3)

• Quantitative Ct-value of RT-PCR

  Between the end of February 2020 and December 2021

• Quantitative SARS-CoV-2 N-Ag concentration in pg/mL

  Between the end of February 2020 and December 2021

• Qualitative rapid Ag-test

  Between the end of February 2020 and December 2021

Study Arms (1)

Confirmed Covid-19

All adult COVID-19 patients and health care workers tested positive in the 7 participating hospitals identified between the end of February 2020 and December 2021.

Other: duration infectiousness

Interventions

duration infectiousness OTHER

is the probability and the duration of being infectious in hospitalized COVID-19 patients, consequently influencing the decision on cessation of isolation

Confirmed Covid-19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All adult COVID-19 patients tested positive in the 7 participating hospitals between the end of February 2020 and December 2021.

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Admission for COVID-19 and tested positive between the end of February 2020 and December 1st 2021.
• Admission for other reasons than COVID-19, but during hospital stay detected with COVID-19.
• Patients ≥18 years old.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded:
• Adult patients with registered opt-out for using clinical and/or laboratory data.
• Patients \<18 years old.

Sponsors & Collaborators

• Anne Voor in 't holt: lead
• Maasstad Hospital: collaborator
• Medisch Spectrum Twente: collaborator
• Elisabeth-TweeSteden Ziekenhuis: collaborator
• Julius Center: collaborator
• HagaZiekenhuis: collaborator
• Leiden University Medical Center: collaborator
• Radboud University Medical Center: collaborator

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3000 CA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum surplus material (samples with DNA) + Stored (frozen) longitudinal nasopharyngeal swabs (samples without DNA)

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Margreet C Vos, Prof. dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Epidemiologist, Assistant Professor

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 26, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: December 31, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At least 10 years
• Access Criteria: Researchers could express their interest in the dataset through a.voorintholt@erasmusmc.nl. After meeting the sharing and reuse conditions and approval of the PI, data access will be provided through the COVID-19 national health RI portal.

Locations

NL (1)