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Post Covid-19 Cardiopulmonary and Immunological Changes (covid-19)

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ClinicalTrials.gov Identifier: NCT04388436
Recruitment Status : Active, not recruiting
First Posted : May 14, 2020
Last Update Posted : May 19, 2020
Sponsor:
Information provided by (Responsible Party):
Mansoura University

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.

Condition or disease
COVID

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
Official Title: Cardiopulmonary and Immunological Impacts of Covid-19 in a Cohort of Survivors
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : July 10, 2021
Estimated Study Completion Date : October 10, 2021



Primary Outcome Measures :
  1. measurement of pulmonary function changes either obstructive or restrictive also lung diffusion and if there is remaining interstitial fibrosis [ Time Frame: 12 months ]
    pulmonary function include lung volumes in millimetre and lung capacities

  2. measurement for cardiac function and ejection fraction changes and if there is changes in pulmonary artery pressure [ Time Frame: 12 months ]
    Ejection fraction ,myocardial contractility,pulmonary artery pressure


Secondary Outcome Measures :
  1. assessment of IGM and IGG level and if there is immunological changes [ Time Frame: 12 months ]
    IGG,IGM level using rapid covid antibody titre



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
covid-19 pcr positive survivors
Criteria

Inclusion Criteria:

  • pcr positive for covid -19 who are survived

Exclusion Criteria:

  • dead patient uncooperative

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388436


Locations
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Egypt
Mansoura faculty of medicine
Mansoura, Dakahlia, Egypt, 35511
Sponsors and Collaborators
Mansoura University
Investigators
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Principal Investigator: Tamer A Elhadidy, MD assistant professor
Additional Information:
Publications:

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Responsible Party: Mansoura University
ClinicalTrials.gov Identifier: NCT04388436    
Other Study ID Numbers: 20.05.67
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan for sharing data for other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mansoura University:
covid-19 cardiopulmonary immunological impact