Clincosm LogoSign in Get a demo

Persistence of Symptoms After Improvement of Acute COVID-19

Sponsor
Sohag University (Other)
Overall Status
Completed
CT.gov ID
NCT04764773
Collaborator
(none)
172
Enrollment
1
Location
11
Actual Duration (Months)
15.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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.

Study Design

Study Type:
Observational
Actual Enrollment :
172 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Persistence of Symptoms After Improvement of Acute COVID19 Infection in Sohag Governorate, Egypt, A Longitudinal Study
Actual Study Start Date :
May 1, 2020
Actual Primary Completion Date :
Feb 28, 2021
Actual Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Case

Patient who had COVID19 infection

Other: No intervention
No intervention
control

healthy volunteer who were age and sex matched with our patients

Other: No intervention
No intervention

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Type of persistent symptom after acute covid19 [during the period from the start of June 2020 to the end of July 2020]

  3. Risk factors for persistent symptoms after recovery of acute covid19 [during the period from 15th May,2020 to the end of February, 2021]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mona Mohammed Abdelrahman Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

  • Study Chair: Noha Abdelrahman, assistant-lecturer, Sohag University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mona Mohammed Abdelrhman, Principal investigator, Sohag University
ClinicalTrials.gov Identifier:
NCT04764773
Other Study ID Numbers:
  • Soh-Med-21-02-46
First Posted:
Feb 21, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mona Mohammed Abdelrhman, Principal investigator, Sohag University
Persistent symptoms
Recovery
COVID-19
Additional relevant MeSH terms:
Infections
COVID-19
Coronavirus Infections

Study Results

No Results Posted as of Nov 2, 2021