CompletedNot Applicable

PROSAIC-19 - Prospective Longitudinal Assessment in a COVID-19 Infected Cohort

United Kingdom161 participantsStarted 2020-06-18

Plain-language summary

DESIGN Longitudinal prospective observational multicentre study. Primary objective: Understand the immune mechanisms driving COVID-19 disease in patients with a history of lung disease

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All patients ≥16 years old with confirmation of COVID-19
. All patients ≥ 16 years old with chronic lung disease (CF, non-CF bronchiectasis, asthma, COPD or Idiopathic Pulmonary Fibrosis) or with no evidence of prior chronic lung disease
. Healthy volunteers

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anti-viral cytokine levels in blood samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

Timeframe: Through study completion an average of 1 year

Anti-viral cytokines profiles within sputum samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

Timeframe: Through study completion an average of 1 year

Anti-viral cytokine profiles within nasal lavage samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection associated with susceptibility to severe COVID-19 infection

Timeframe: Through study completion an average of 1 year

Expression of inflammatory gene expression in upper respiratory epithelial airway cells using nasal brush specimens in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

Timeframe: Through study completion an average of 1 year

Trial details

NCT IDNCT04444609

SponsorImperial College London

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-17

View on ClinicalTrials.gov More COVID-19 trials

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. All patients ≥16 years old with confirmation of COVID-19
. All patients ≥ 16 years old with chronic lung disease (CF, non-CF bronchiectasis, asthma, COPD or Idiopathic Pulmonary Fibrosis) or with no evidence of prior chronic lung disease
. Healthy volunteers

What they're measuring

Anti-viral cytokine levels in blood samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

Timeframe: Through study completion an average of 1 year

Anti-viral cytokines profiles within sputum samples in chronic respiratory disease associated with susceptibility to severe COVID-19 infection

Timeframe: Through study completion an average of 1 year