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

COVID-19 Clinical Trial

— TREAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05529771
• Other study ID #: EG0281
• Status: Completed
• Start date: September 22, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: January 2024
• Source: Elizabeth Glaser Pediatric AIDS Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Rationale:

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus first identified in December of 2019 in Wuhan, China. Since the first case of COVID-19 was diagnosed in 2019, the number of cases has exponentially increased globally. As of December 16th 2021, there have been over 270 million confirmed cases of COVID-19 and over 5.3 million deaths from COVID-19 across the world. Zimbabwe is one of the countries in Southern Africa affected by the COVID-19 pandemic. World Health Organization (WHO) recommended treatment with IL-6 receptor blockers for patients with severe or critical COVID-19 disease in addition to the previous recommendation of systemic corticosteroids.

Primary objectives

1. To describe the clinical course and outcomes of patients admitted to the Harare Teaching Hospital - Parirenyatwa General Hospital with SARS-CoV-2 infection.

1. Clinical course includes disease severity, use of oxygen, ICU admission, mechanical ventilation, treatments received, and duration of care.

2. Outcomes include death, discharged or still hospitalized.

3. Among discharged, outcomes will include readmission, persistent symptoms or recovery at 3 months post diagnosis.

2. To determine individual-level factors associated with clinical course and disease outcome including but not limited to demographics, population (healthy adults, children, pregnant women), comorbidities (i.e. HIV, TB, diabetes, cardiovascular disease [CVD], obesity), SARS-CoV-2 vaccine status, lab/medical history, COVID-19 treatment, and disease severity at presentation.

Secondary objective

1. To document pharmacovigilance around the use of new COVID-19 treatments, including side effects and any associated treatment interruptions.

Design: We propose an observational cohort study with a retrospective and a prospective component to collect data on patients admitted to Parirenyatwa and Harare Hospitals with SARS-CoV-2 infection for COVID-19 care. Retrospective review and abstraction of information from medical records will be conducted on all COVID-19 admissions from January 2022 to July/August 2022 depending on when all approvals are in place to initiate primary data collection. Subsequently, the study team will enroll participants through March 2023 and prospectively follow all admitted COVID-19 patients until they meet a clinical outcome (death, discharge) up to 3 months after SARS-CoV-2 diagnosis. Data on disease progression, need for oxygen, ICU care or mechanical ventilation, treatments received, treatment side effects, laboratory results, duration of hospitalization and outcome (death, discharge or still hospitalized) will be abstracted from all patient medical records. For patients enrolled in the prospective cohort, a detailed medical and SARS-CoV-2 related history will be collected at the admission to the hospital. In addition, study staff will conduct short telephone interviews with study participants to document their course at home after discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• None.

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
Zimbabwe	Parirenyatwa General Hospital	Harare

Sponsors (2)

Lead Sponsor	Collaborator
Elizabeth Glaser Pediatric AIDS Foundation	UNITAID

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease severity	Number of patients died, discharged, or still hospitalized, as a proportion of patients admitted with COVID-19 disease	3 months
Primary	Discharged patients	Number of patients readmitted, experiencing persistent symptoms, recovered, as a proportion of patients admitted with COVID-19 disease	3 months
Secondary	COVID-19 Treatment Pharmacovigilance	Types of side effects, and/or any associated treatment interruptions	3 months