Trial Outcomes & Findings for Predicting Severity and Disease Progression in Influenza-like Illness (Including COVID-19) (NCT NCT04664075)

Last Updated: 2024-05-17

Results Overview

The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record

Recruitment status

TERMINATED

Target enrollment

8 participants

Primary outcome timeframe

Day 0 to Day 28

Results posted on

2024-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Persons Aged ≥ 18 Years Healthy persons aged ≥ 18 years who meet the inclusion/exclusion criteria
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predicting Severity and Disease Progression in Influenza-like Illness (Including COVID-19)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Persons Aged ≥ 18 Years n=8 Participants Healthy persons aged ≥ 18 years who meet the inclusion/exclusion criteria
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Mixed (White and Asian)	2 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Asian or Asian British (Indian)	3 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · White British	2 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · White Other	1 Participants n=5 Participants
Region of Enrollment United Kingdom	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 28

Population: 8 participants were enrolled into this study with a diagnosis of ARI (Acute Respiratory Infection)

The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record

Outcome measures

Outcome measures
Measure	Healthy Persons Aged ≥ 18 Years n=8 Participants Healthy persons aged ≥ 18 years who meet the inclusion/exclusion criteria
Describe the Aetiology of Influenza-like Illness in Hospitalised Adults SARS-CoV-2	4 Participants
Describe the Aetiology of Influenza-like Illness in Hospitalised Adults No pathogen	4 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 28

Population: 8 participants who were enrolled had a diagnosis of Acute Respiratory Illness (ARI) then recovered and were discharged home.

Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.

Outcome measures

Outcome measures
Measure	Healthy Persons Aged ≥ 18 Years n=8 Participants Healthy persons aged ≥ 18 years who meet the inclusion/exclusion criteria
Describe the Clinical Outcomes of Influenza-like Illness in Hospitalised Adults Acute Lung Injury/Acute Respiratory Distress syndrome	1 Participants
Describe the Clinical Outcomes of Influenza-like Illness in Hospitalised Adults ARI and hyperglycaemia	1 Participants
Describe the Clinical Outcomes of Influenza-like Illness in Hospitalised Adults ARI secondary to SARS-CoV-2 infection	2 Participants
Describe the Clinical Outcomes of Influenza-like Illness in Hospitalised Adults ARI with no causative pathogen found	1 Participants
Describe the Clinical Outcomes of Influenza-like Illness in Hospitalised Adults ARI with no causative pathogen found with partial middle lobe collapse and anaemia	2 Participants
Describe the Clinical Outcomes of Influenza-like Illness in Hospitalised Adults ARI with left lower lobe abscess and dermatitis	1 Participants

PRIMARY outcome

Timeframe: Day 0 to Day 28

Population: 8 participants were enrolled into this study. 6 participants, 3 of which with confirmed SARS-CoV-2 infection, received a steroid treatment. 7 participants received a treatment course of antibiotics. 1 participant did not receive any antibiotics, this participant did not have a confirmed causative respiratory pathogen found. 4 participants received Remdesivir (antiviral), three of which had a positive PCR test for SARS-CoV-2, one without.

Describe the Clinical Management of Influenza-like Illness in Hospitalised Adults

Outcome measures

Outcome measures
Measure	Healthy Persons Aged ≥ 18 Years n=8 Participants Healthy persons aged ≥ 18 years who meet the inclusion/exclusion criteria
Describe the Clinical Management of Influenza-like Illness in Hospitalised Adults Antibiotic + Steroid Treatment	3 Participants
Describe the Clinical Management of Influenza-like Illness in Hospitalised Adults Antibiotic Treatment	1 Participants
Describe the Clinical Management of Influenza-like Illness in Hospitalised Adults Antibiotic + Antiviral Treatment	1 Participants
Describe the Clinical Management of Influenza-like Illness in Hospitalised Adults Antibiotic + Antiviral + Steroid Treatment	2 Participants
Describe the Clinical Management of Influenza-like Illness in Hospitalised Adults Antiviral + Steroid Treatment	1 Participants

SECONDARY outcome

Timeframe: Day 0 to Day 28

Population: As we only recruited 8 participants out of the 100 recruitment target, the cytokine assays were not run and therefore no results are available for this outcome measure due to the poor recruitment.

Cytokine levels (in pg/mL) will be measured in plasma and nasal lining fluid samples by MesoScale Discovery

Outcome measures

Outcome data not reported

Adverse Events

Healthy Persons Aged ≥ 18 Years

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Healthy Persons Aged ≥ 18 Years n=8 participants at risk Healthy persons aged ≥ 18 years who meet the inclusion/exclusion criteria
Respiratory, thoracic and mediastinal disorders Respiratory Failure	12.5% 1/8 • Day 0 to Discharge or Day 28 (whichever came first) Adverse Events and Serious Adverse Events were captured from the time of consent until the time of discharge.

Other adverse events

Adverse event data not reported

Additional Information

Senior Clinical Research Nurse

Imperial College London

Phone: 02083833231

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place