Clinical Outcomes of paTients pREsenting to HArare COVID-19 CenTer of Excellence With SARS-CoV-2 Infection

NCT05529771 | Completed

• 1 other identifier: EG0281
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

In order to influence COVID-19 treatment guidelines, evidence on disease progression and clinical outcomes of hospitalized COVID-19 patients, particularly those receiving innovative COVID-19 medications in an African setting is critical. This study will be conducted by EGPAF to describe patient characteristics, COVID-19 illness progression, and clinical outcomes among hospitalized COVID-19 patients at Parirenyatwa General and Harare Teaching Hospitals, COVID Centers of Excellence at in Zimbabwe.

Conditions

COVID-19

Keywords

Antigen rapid diagnostic test; COVID-19; Health Facilities; Africa

Outcome Measures

Primary Outcomes (2)

• Disease severity

  Number of patients died, discharged, or still hospitalized, as a proportion of patients admitted with COVID-19 disease

  3 months

• Discharged patients

  Number of patients readmitted, experiencing persistent symptoms, recovered, as a proportion of patients admitted with COVID-19 disease

  3 months

Secondary Outcomes (1)

• COVID-19 Treatment Pharmacovigilance

  3 months

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the study facility for COVID-19 care and treatment during the study period regardless of age or disease state. A sample size of approximately 400 participants is estimated to be included, but could be fewer or higher number of participants depending on the stage of the pandemic.

You may qualify if:

• Patient admitted with documented SARS-CoV-2 infection.
• Willing and able to provide written informed consent or parental consent (with assent if applicable) for the prospective study cohort.

You may not qualify if:

• None.

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• UNITAID: collaborator

Study Sites (1)

Parirenyatwa General Hospital

Harare, Zimbabwe

Location

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Nilesh Bhatt

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Simba Mashizha

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: September 22, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

ZI (1)