NCT05228626

Safety and Efficacy of COVIDEX™ Therapy in Management of Adult COVID-19 Patients in Uganda.

Safety and Efficacy of COVIDEX™ Therapy in Management of Adult Covid-19 Patients in Uganda: A Randomized Double-blind Placebo Controlled Adaptive Phase 2 B Clinical Trial.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 584 (estimated)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 cover the worldwide demand hence researchers worldwide are urgently looking for interventions to prevent new infections, prevent disease progression, and lessen disease severity for those already infected. While a number of claims on efficacy of herbal remedies on COVID-19 have been made, to our knowledge none of such claims have gained on scientific basis for continued use or further research and development of the constituents into investigational products. In Uganda, one of such herbal remedies is COVIDEX, this study therefore seeks to investigate the safety and efficacy of COVIDEX in the management of COVID-19.

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 cover the worldwide demand hence researchers globally are urgently looking for interventions to prevent new infections, prevent disease progression, and lessen disease severity for those already infected. According to data released by the ministry of health, Uganda had 94,904 confirmed cases with 2752 deaths at the end of July 2021 (MoH, 2021). Fortunately, most of the cases confirmed had a mild illness for whom home-based symptomatic management with monitoring of clinical deterioration as per World Health Organization recommendations is sufficing (WHO, 2021b). However, despite providing symptomatic management, a therapeutic drug that would limit infection is greatly needed to stop COVID-19 disease progression. While a number of claims on efficacy of herbal remedies on COVID-19 have been made, to our knowledge none of such claims have gained on scientific basis for continued use or further research and development of the constituents into investigational products. COVIDEX is a herbal formulation containing berberine as a primary anti-SARSCOV-2 compound notified by the Uganda National Drug Authority for supportive treatment in managing viral infections. Notably, this notification was done with a call for clinical trials to validate the claims of its anti-SARS COV-2 activity. This study therefore proposes to investigate the safety and efficacy of COVIDEXTm therapy in managing COVID-19 disease.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	COVIDEX	COVIDEXTm is a prepared plant extract of Zanthoxylum and Warbugia species that is reported to have antiviral agents, one of which berberine with in vitro activity against SARS COV-2, the causative agent for COVID-19 disease. Others constituents in COVIDEX include alkaloids, sponins, reducing sugars and acidic compounds. IT is given either 2 drops nasally plus 6 drops orally or 6 oral drops only of COVIDEXTm three times daily for 7 days.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2022-02-08
• Last updated: 2022-03-02

Locations

1 site across 1 country: Uganda