Clinical trial NCT04764773: Persistence of Symptoms After Improvement of Acute COVID-19
Official title: Persistence of Symptoms After Improvement of Acute COVID19 Infection in Sohag Governorate, Egypt, A Longitudinal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corona Virus Infection
Keywords: Persistent symptoms
Recovery
COVID-19
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 172
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patient who had persistent symptoms after recovery of acute covid19
timeFrame: during the period from 15th May,2020 to the end of February, 2021
measure: Type of persistent symptom after acute covid19
timeFrame: during the period from the start of June 2020 to the end of July 2020
measure: Risk factors for persistent symptoms after recovery of acute covid19
timeFrame: during the period from 15th May,2020 to the end of February, 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mona Mohammed Abdelrahman
Study officials:
affiliation: Sohag University
name: Noha Abdelrahman, assistant-lecturer
role: STUDY_CHAIR
References:
citation: 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.
citation: Abdelrahman MM, Abd-Elrahman NM, Bakheet TM. Persistence of symptoms after improvement of acute COVID19 infection, a longitudinal study. J Med Virol. 2021 Oct;93(10):5942-5946. doi: 10.1002/jmv.27156. Epub 2021 Jul 2.