Long Term Sequelae of COVID-19: Follow-up Study in Dhaka, Bangladesh

NCT05242185 | Unknown DMC

• 1 other identifier: PR-20128
• Study Type: observational
• Target: 398
• Locations: 1 country
• Sites: 1

Brief Summary

COVID-19 or coronavirus disease 2019 is an emerging infectious disease. The disease was first identified in China and then spread worldwide; hence, declared as a global pandemic on March 11, 2020 by World Health Organization (WHO). The pandemic is posing formidable challenges to healthcare systems and humanities worldwide resulting in morbidities and mortalities unthought of. Rapidly accumulating clinical evidence on COVID-19 paved the way for an extensive and prompt characterization of the acute phase of the disease. The clinical presentation is generally that of a respiratory infection with a symptom severity ranging from a mild common cold-like illness, to a severe viral pneumonia leading to acute respiratory distress syndrome that is potentially fatal. Characteristic symptoms include fever, cough, and dyspnoea, although some patients may be asymptomatic. Complications of severe disease include, but are not limited to, multi-organ failure, septic shock, and acute respiratory distress syndrome. The COVID-19 infection fatality rate is between 0.5 and 1 percent and the remaining affected patients will mostly recover but need convalescent care. However, discharge should not be considered as the final point of overcoming coronavirus and till date evidence on sequelae of the COVID-19 recovered patients is very limited. COVID-19 is a complex multisystem disease that affects pulmonary function, as well as renal, cardiovascular, and neuropsychiatric health, metabolic derangement; and nutritional status. The extent to which these alterations may persist remains obscure, till date evidence on long term sequelae of the COVID-19 recovered patients is very limited. Some of the aftereffects of it may have a profound impact on 'recovered' patients in the future. Long-term morbidities were observed in survivors of severe acute respiratory syndrome but it is unidentified whether experience from SARS is applicable to COVID-19. The SARS-CoV-2 infection is severe in older, immune deficient people and who have any pre-existing medical conditions. Hence, it is imperative to comprehend the possible long-term sequelae of the COVID-19 recovered patients, and if they will develop any other harmful illnesses. This study would help us to understand the in-depth prognosis and sequelae of the disease, as well as help to uncover to what extent would COVID-19 recovered patients require post-acute care to recuperate from any further infections or multi-organ damage.

Conditions

COVID-19

Keywords

COVID-19, long term sequelae

Outcome Measures

Primary Outcomes (1)

• The primary end point will be the prevalence and incidence of long term sequelae of COVID-19

  1. Incidence and prevalence of long-term sequelae 2. Persistence or development of symptoms at different time-points of follow-up in mild, moderate or severe disease symptoms like * dyspnea, * fatigue, * cough, * fever, * thoracic pain, * nausea, * diarrhea, * headache

  24 months

Secondary Outcomes (1)

• Prevalence and incidence of long term (after 6 weeks) sequelae among OPD and hospitalized group COVID-19

  24months

Study Arms (1)

COVID-19 survivors

All patients age 18years and more who have SARS-CoV-2 infection confirmed by reverse-transcriptase polymerase-chain-reaction assay (RT-PCR) following their discharge from Dhaka hospital or outpatient clinic or inpatient wards of BSMMU

Other: Observational study

Interventions

Observational study OTHER

\- Baseline data of prognostic importance, including demographic, social information, lifestyle factors, medical history, underlying comorbidities, anthropometric measurements, clinical, laboratory, imaging and treatment records will be collected using a standard case report form. A detailed clinical examination including measurement of vital signs, blood pressure, pulse oximetry, anthropometric measurements, neurological, pulmonary, cardiovascular system examination, mental and fuctional status assessment. routine laboratory assays including complete blood count (CBC), serum alanine transaminase (ALT), serum creatinine, fasting capillary blood glucose using glucometer and urine routine examination, ECG, echocardiography, chest X-ray and pulmonary function test. Additional tests when required such as fasting blood sugar, glycated haemoglobin, MRI/CT scan of brain, Thyroid function tests such as FT4, FT3 and TSH and C peptide etc

Also known as: Follow- up

COVID-19 survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include all patients who have SARS-CoV-2 infection confirmed by reverse-transcriptase polymerase-chain-reaction assay (RT-PCR) following their discharge from Dhaka hospital or outpatient clinic or inpatient wards of BSMMU

You may qualify if:

• Age ≥ 18 years
• Participants categorized as mild, moderate and severe/critical disease according to the classification of WHO and the national guideline on COVID-19 case management published by the DGHS \[28\], Bangladesh and discharged from the hospital or outpatient clinic
• Participants residing within Dhaka city corporation area
• Willing to participate in this study

You may not qualify if:

• Participants will be excluded if they have a history mental illness before COVID-19
• Participants with RT-PCR-confirmed SARS-CoV-2 infections but without any relevant clinical symptoms in the preceding fourteen days will be excluded.
• Participants residing outside the Dhaka city corporation area and not willing to participate in the study
• Same as exposed group except that they are not exposed to SARS-CoV-2 infection as evident by negative RT-PCR test. Other criteria for comparison group are given below.
• Participants will be included if the RT-PCR test is negative during enrollment
• Age ≥ 18 years
• Participants residing within Dhaka city corporation area
• Willing to participate in this study
• Participants with any known co morbidities including obesity will be excluded

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

ICDDR,B

Dhaka, 1212, Bangladesh

Location

MeSH Terms

Conditions

COVID-19

Interventions

Observation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 16, 2022
• Study Start: February 8, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

BA (1)