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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04764773
Other study ID # Soh-Med-21-02-46
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date March 31, 2021

Study information

Verified date November 2021
Source Sohag University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Coronavirus disease pandemic has been started in late 2019. Survivors of COVID-19 are significantly more likely to develop clinical sequelae three months after discharge from the hospital than those without COVID-19 infection. This is true not only for general and respiratory symptoms but also for cardiovascular and psychosocial symptoms. This suggests that these symptoms may indeed be the sequelae of recovery for COVID-19 survivors. So, we aimed to detect the prevalence and to evaluate the type of symptoms that could persist after the recovery from COVID19 infection in Sohag governorate, Egypt.


Description:

About one hundred patients who were test positive for SARS-CoV2 and were improved and discharged from Sohag isolation hospitals and isolation department for COVID19 in Sohag University hospitals during the period from 15th May, 2020 to 25th July, 2020 will be included in our study. Patient improvement and discharge criteria include 10 day from symptoms onset in addition to 3 day free of fever and respiratory symptoms. Patients with severe complex illness, pregnant or lactating females and patient who refuse to participate or give complete detailed history will be excluded from the study. The study protocol will be approved by the scientific Research Ethical committee, Faculty of Medicine, Sohag University A control group of healthy volunteer who were age and sex matched to our patient were included After taken informed consent according to Sohag University Ethical Committee, the baseline data will be collected from Sohag isolation hospital of COVID19, then the researchers will perform interviews with all participants through mobile phone. The interview will include: - Name (Optional) - Age - Sex - Occupation - Presence of DM, HTN or any chronic illness - Asking about Smoking - The date of catching COVID19 infection - Asking about symptoms of COVID19 infection and duration of each symptom. - Asking about any residual symptoms as: Fatigue, Myalgia, Arthralgia, Chest pain, Dyspnea, Dry cough, Productive cough, Sore Throat, Anosmia, Loss of taste sensation, Nausea, Anorexia, Diarrhea, Redness of the eye, Headache, Confusion and Depression Statistical analysis: Data will be analyzed using STATA version 14.2 (Statistical Software: Release 14.2 College Station, TX: Stata Corp LP). Quantitative data will be represented as mean, standard deviation, median and range. normally distributed. Qualitative data will be presented as numbers and percentages. Chi square test will be used for comparison of percentages in different groups. P value will be considered significant if it was less than 0.05.


Recruitment information / eligibility

Status Completed
Enrollment 172
Est. completion date March 31, 2021
Est. primary completion date February 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Positive for SARS-CoV2 Exclusion Criteria: - Patients with severe complex illness, pregnant or lactating females and patient who refuse to participate or give complete detailed history

Study Design


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
Egypt Mona Mohammed Abdelrahman Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Xiong Q, Xu M, Li J, Liu Y, Zhang J, Xu Y, Dong W. Clinical sequelae of COVID-19 survivors in Wuhan, China: a single-centre longitudinal study. Clin Microbiol Infect. 2021 Jan;27(1):89-95. doi: 10.1016/j.cmi.2020.09.023. Epub 2020 Sep 23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patient who had persistent symptoms after recovery of acute covid19 during the period from 15th May,2020 to the end of February, 2021
Primary Type of persistent symptom after acute covid19 during the period from the start of June 2020 to the end of July 2020
Primary Risk factors for persistent symptoms after recovery of acute covid19 during the period from 15th May,2020 to the end of February, 2021
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