Long Term Impact on Lung Function of Patients With Moderate and Severe COVID-19. A Prospective Cohort Study

  1. Sonia Qureshi
  2. Nosheen Nasir
  3. Naveed Rashid
  4. Naveed Ahmed
  5. Zoya Haq
  6. Farah Qamar

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Abstract

Background: In Pakistan, the cases of COVID-19 have declined from 6000 per day in June to 600 in September 2020. A significant number of patients continue to recover from the disease, however, little is known about the lung function capacity among survivors. We aim to determine the long-term impact on lung function capacity in patients who have survived moderate or severe COVID-19 disease in a resource-poor setting.

Methods: This prospective cohort study will be conducted at Aga Khan University Hospital (AKUH), Karachi Pakistan. Patients 15 years and above who have survived an episode of moderate or severe COVID-19, have reverse transcriptase-polymerase chain reaction (RT-PCR) positive for COVID 19 (nasopharyngeal or oropharyngeal) will be included. Patients with a pre-existing diagnosis of obstructive or interstitial lung disease, lung fibrosis, lung cancers, connective tissue disorders, autoimmune conditions affecting the lungs, underlying heart disease, history of syncope and those who refuse to participate will be excluded from the study. Pulmonary function will be assessed using spirometry and diffusion lung capacity for carbon monoxide (DLCO) at 3- and 6-months interval from the time of discharge from the hospital. Additionally, a chest X-ray and CT-chest will be performed if clinically indicated after consultation with the study pulmonologist or Infectious Disease (ID) physician. Echocardiogram (ECHO) will be performed to look for pulmonary hypertension at the 3 month visit and repeated at 6 months in case any abnormality is identified in the initial ECHO. Data analysis will be performed using standard statistical software. The study was approved by the Ethical Review Committee (ERC) of the institution (ERC reference number 2020-4735-11311).

Strengths and Limitations of the Study: This cohort study will provide evidence on the long-term impact on lung function among COVID-19 survivors with moderate to severe disease. Such data will be key in understanding the impact of the disease on vital functions and will help devise rehabilitative strategies to best overcome the effects of disease. However, this will be a single-center, study recruiting only a limited number of COVID-19 survivors.

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  1. Version published to 10.3389/fpubh.2021.663076
  2. ScreenIT

    SciScore for 10.1101/2021.01.06.21249312: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board StatementConsent: Participants will be contacted over phone within one month of discharge from hospital and verbal consent will be obtained Once the consent has been obtained, an appointment for pulmonary function test (spirometry/ DLCO), chest x-ray and echocardiogram (ECHO) will be scheduled at third month post discharge (first follow up).
    IRB: Planning and Training: Necessary approvals from ethical review committees will be taken.
    IACUC: Ethical Consideration: The project was approved by the Ethical Review Committee (ERC) of the AKUH (ERC reference number 2020-4735-11311).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    ECHO will be repeated only if an abnormality is reported at the 3 months follow up.
    ECHO
    suggested: (ECHO, RRID:SCR_011851)
    Data will be entered in SPSS and stored in password protected-user specific computer database.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    There are several strengths and limitations of the study. Recruitment will be using a prospective approach which will be helpful in monitoring the course of the disease in real time and plan and prescribe any intervention as needed. The variables in the study have been selected after thorough literature search and opinion of the experts in the field of infectious diseases. The study team includes a mix of researchers, physicians trained in the field of infectious diseases, coordinators and field staff trained in managing mega projects by maintaining quality standards of data management. The findings will play crucial role in the development of programs for survivors at population level. The study findings will be disseminated to stakeholders including; community, government and academia. Moreover, strategies to avert consequences of disease such as a rehabilitation programs could be devised based on the study findings. This is a single center study with a small sample size. The current sample size may not be the representative of population at large however; the study has strong potential to develop evidence on the current state of lung function among survivors. Follow-up at six-months could be a challenge with the unpredictable pandemic situation.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.01.06.21249312v1 on medRxiv