NCT05274373

Brief Summary

Assessment of the association between the severity of COVID-19 and SARS-CoV-2 NAb titers levels for up to six months following primary infection using a live virus NAb assay. Description of SARS-CoV-2 viral shedding and infectiousness during the first 30 days after infection in a group of unvaccinated hospitalized patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

March 8, 2022

Last Update Submit

March 9, 2022

Conditions

COVID-19 PneumoniaCOVID-19

Keywords

Neutralizing AntibodiesViral LoadAntibody DecayViral CulturingInfectiousness

Outcome Measures

Primary Outcomes (12)

  • Neutralizing Antibody Titer - Day 0

    Baseline Log10 Spike protein neutralizing antibody titer

    Day 0

  • Change from baseline in Neutralizing Antibody Titer - Day 30

    Log10 Spike protein neutralizing antibody titer

    Day 30

  • Change from baseline in Neutralizing Antibody Titer - Day 90

    Log10 Spike protein neutralizing antibody titer

    Day 90

  • Change from baseline in Neutralizing Antibody Titer- Day 180

    Log10 Spike protein neutralizing antibody titer

    Day 180

  • Viral culturing - Day 0

    Number of successful viral culturing attempts (SARS-CoV-2)

    Day 0

  • Viral culturing - Day 3

    Number of successful viral culturing attempts (SARS-CoV-2)

    Day 3

  • Viral culturing - Day 7

    Number of successful viral culturing attempts (SARS-CoV-2)

    Day 7

  • Viral culturing - Day 10

    Number of successful viral culturing attempts (SARS-CoV-2)

    Day 10

  • Viral culturing - Day 14

    Number of successful viral culturing attempts (SARS-CoV-2)

    Day 14

  • Viral culturing - Day 17

    Number of successful viral culturing attempts (SARS-CoV-2)

    Day 17

  • Viral culturing - Day 24

    Number of successful viral culturing attempts (SARS-CoV-2)

    Day 24

  • Viral culturing - Day 30

    Number of successful viral culturing attempts (SARS-CoV-2)

    Day 30

Secondary Outcomes (8)

  • Baseline Viral Load - Day 0

    Day 0

  • Change from Baseline Viral Load - Day 3

    Day 3

  • Change from Baseline Viral Load - Day 7

    Day 7

  • Change from Baseline Viral Load - Day 10

    Day 10

  • Change from Baseline Viral Load - Day 14

    Day 14

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult unvaccinated hospitalized patients

You may qualify if:

  • positive SARS-CoV-2 specimen from upper or lower respiratory tracts (virological criteria)
  • consolidations on the chest X-ray described by a radiologist, treating physician or a physician from the study group (radiological criteria)
  • the presence of one or more of the following: fever (temperature ≥38.0°C), new-onset cough, pleuritic chest pain, dyspnea or altered breath sounds on auscultation (clinical criteria)

You may not qualify if:

  • cognitive impairment prohibiting giving informed consent to participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital at North Zealand

Copenhagen, 25482, Denmark

Location

Related Publications (1)

  • Sejdic A, Frische A, Jorgensen CS, Rasmussen LD, Trebbien R, Dungu A, Holler JG, Ostrowski SR, Eriksson R, Soborg C, Nielsen TL, Fischer TK, Lindegaard B, Franck KT, Harboe ZB. High titers of neutralizing SARS-CoV-2 antibodies six months after symptom onset are associated with increased severity in COVID-19 hospitalized patients. Virol J. 2023 Jan 25;20(1):14. doi: 10.1186/s12985-023-01974-8.

    PMID: 36698135DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Oropharyngeal swabs 2. Serum

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Zitta Barrella Harboe, MD, PhD

    Nordsjaellands Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 10, 2022

Study Start

May 24, 2020

Primary Completion

May 5, 2021

Study Completion

October 1, 2023

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

DK(1)