Post Covid-19 Cardiopulmonary and Immunological Changes

NCT04388436 | Unknown

• 1 other identifier: 20.05.67
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Study rationale and aim: Resolving the COVID-19 pandemic quickly hinges on a crucial factor: how well a person's immune system remembers SARS-CoV-2, the virus behind the disease, after an infection has resolved and the patient is back in good health. This phenomenon, called immune memory, helps our bodies avoid reinfection by a bug persons have had before and influences the potency of life-saving treatments and vaccines. Also, the new coronavirus causes cardiac and pulmonary inflammation. So, our study planned to measure the cardiopulmonary and immunological changes in treated COVID-19 patients. Specific objectives: Measurement the duration of existence of COVID-19 IgM and IgG antibody in patient's plasma, detection of cardiac changes, pulmonary radiological and functional changes after COVID-19 infection. This could help detection of functional impairment in COVID-19 survivors which may have economic and social impact. Also, investigator will assess possible protective immune response following infection which may affect vaccination schedule. Methods: One hundred RT- PCR positive COVID-19 patients will be enrolled. HRCT chest, lateral flow immunoassay, spirometry, DLCO and Echo will be done on after 3, 6 and 12 months of discharge.

Conditions

COVID

Keywords

covid-19 cardiopulmonary immunological impact

Outcome Measures

Primary Outcomes (2)

• measurement of pulmonary function changes either obstructive or restrictive also lung diffusion and if there is remaining interstitial fibrosis

  pulmonary function include lung volumes in millimetre and lung capacities

  12 months

• measurement for cardiac function and ejection fraction changes and if there is changes in pulmonary artery pressure

  Ejection fraction ,myocardial contractility,pulmonary artery pressure

  12 months

Secondary Outcomes (1)

• assessment of IGM and IGG level and if there is immunological changes

  12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

covid-19 pcr positive survivors

You may qualify if:

• pcr positive for covid -19 who are survived

You may not qualify if:

• dead patient uncooperative

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura faculty of medicine

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (14)

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  PMID: 17374415 BACKGROUND

Related Links

• Viral kinetics and antibody responses in patients with COVID-19
• Antibody testing for COVID-19: A report from the National COVID Scientific Advisory Panel

Study Officials

• Tamer A Elhadidy, MD

  assistant professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: May 11, 2020
• Primary Completion: July 10, 2021
• Study Completion: October 10, 2021
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)