Status:
UNKNOWN
Safety and Efficacy of COVIDEX™ Therapy in Management of Adult COVID-19 Patients in Uganda.
Lead Sponsor:
Makerere University
Collaborating Sponsors:
Mbarara University of Science and Technology
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The SARS-CoV-2 pandemic continues to grow, with over 350,000 new infections and over 7,000 daily global deaths in May 2021 (WHO, 2021a). The current supplies of protective vaccines are too low to cove...
Detailed Description
The SARS-CoV-2 pandemic continues to grow, with over 350,000 new infections and over 7,000 daily global deaths in May 2021 (WHO, 2021a). The current supplies of protective vaccines are too low to cove...
Eligibility Criteria
Inclusion
- Provision of signed/thumb printed and dated informed consent form
- Willingness to comply with all study procedures and availability over the study duration
- Patients aged 18years and above
- Positive SARS-CoV-2 antigen rapid test and/or PCR positive for SARS-Cov-2 (COVID-19)
- Symptomatic patients in the following categories; mild, moderate and severe: mild score 2 (limitation of activities), Moderately ill COVID-19 patients WHO score 3(Hospitalized with no oxygen therapy), which translates to moderately ill patients according to MOH Uganda, WHO Score 4 (Hospitalized with oxygen by mask or nasal prongs) and WHO score 5 (Non-invasive ventilation or high flow oxygen) which translates to severe COVID-19 disease on high flow oxygen patients according to the MOH Uganda COVID-19 disease category.
Exclusion
- Patients who report use of COVIDEX with-in three days prior to presentation to the hospital.
- Clinical diagnosis of severe renal (defined by GFR ≤ 29 mL/min/1.73 m2) and hepatic impairment (defined by \>2.5 times the upper normal value of ALT and AST).
- Pregnancy or breast feeding.
- Current use of remdesivir and molnupiravir therapy.
- Active participation in another clinical trial or using another drug on compassionate use such as fluvoxamide.
- Very ill patients with multiple comorbidities where determination of clinical outcome will be difficult as judged by the attending physician.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
584 Patients enrolled
Trial Details
Trial ID
NCT05228626
Start Date
March 1 2022
End Date
December 31 2022
Last Update
March 2 2022
Active Locations (1)
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1
Makerere University Department of Pharmacology and Therapeutics
Kampala, Uganda, 7072