NCT05225194

Brief Summary

The present multicenter prospective observational study aims to assess the long-term effects of COVID-19 on patients with Acute Respiratory Distress Syndrome (ARDS). This is a hybrid design study with components of cohort and case-control designs. Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization will be followed up for a period of 6 months.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

February 15, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

February 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.7 years

First QC Date

February 1, 2022

Last Update Submit

February 2, 2022

Conditions

COVID-19ARDS

Outcome Measures

Primary Outcomes (1)

  • Diffusion capacity for carbon monoxide

    Proportion of participants with diffusion capacity for carbon monoxide \< 80% of predicted

    The outcome will be assessed 6 months after enrollment

Secondary Outcomes (19)

  • Physical functional status

    The outcome will be assessed at 3 and 6 months after enrollment

  • Instrumental Activities of Daily Living

    The outcome will be assessed at 3 and 6 months after enrollment

  • Muscular function and strength

    The outcome will be assessed at 3 and 6 months after enrollment

  • Score of dyspnea

    The outcome will be assessed at 3 and 6 months after enrollment

  • Utility score of health related quality of life

    The outcome will be assessed at 3 and 6 months after enrollment

  • +14 more secondary outcomes

Study Arms (3)

COVID-19 ARDS survivors

Survivors of hospitalization due to ARDS caused by SAS-CoV-2.

Other: COVID-19Other: ARDS

Non-COVID-19 ARDS survivors

Survivors of hospitalization due to ARDS caused by other etiologies than SARS-CoV-2.

Other: ARDS

Family controls

Family controls of participants with ARDS (either due to COVID-19 or other etiologies) without history of COVID-19 or hospitalization in the last 12 months.

Interventions

COVID-19OTHER

SARS-CoV-2 infection

COVID-19 ARDS survivors
ARDSOTHER

Acute respiratory distress syndrome

COVID-19 ARDS survivorsNon-COVID-19 ARDS survivors

Eligibility Criteria

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

Survivors of hospitalization due to ARDS caused by SARS-CoV-2, survivors of hospitalization due to ARDS caused by other etiologies not associated with SARS-CoV-2, and family controls without history of COVID-19 or hospitalization

You may qualify if:

  • Age ≥18 years;
  • Hospitalization due to COVID-19;
  • Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
  • Diagnosis of ARDS during hospitalization according to the Berlin definition;
  • Expected to survive and be discharged directly home from the hospital.

You may not qualify if:

  • Severe comorbidity with life expectancy less than 3 months;
  • Unavailability to attend the study follow-up appointment;
  • Death during hospitalization;
  • Absence of proxy for patients with communication difficulties;
  • Refusal or withdrawal of agreement to participate.
  • COHORT OF SURVIVORS OF ARDS CAUSED BY OTHER ETIOLOGIES NOT ASSOCIATED WITH COVID-19
  • Age ≥18 years;
  • Hospitalization;
  • Diagnosis of ARDS during hospitalization according to the Berlin definition;
  • Expected to survive and be discharged directly home from the hospital.
  • Severe comorbidity with life expectancy less than 3 months;
  • Unavailability to attend the study follow-up appointment;
  • Death during hospitalization;
  • History of SARS-CoV-2 infection within the last 12 months;
  • Absence of proxy for patients with communication difficulties;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Regis G Rosa, MD, PhD

    Hospital Moinhos de Vento

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Geraldine Trott, PhD

CONTACT

+5551994407117geraldine.trott@hmv.org.br

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 4, 2022

Study Start

February 15, 2022

Primary Completion

November 15, 2023

Study Completion

November 15, 2023

Last Updated

February 4, 2022

Record last verified: 2022-01