What Is Covidex Drug?
COVIDEX, a local herbal medicine, has finally been approved by Uganda’s National Drug Authority (NDA) as a supporting treatment for viral infections including Covid-19.
How To Use Covidex Drug In Uganda
Study Design Of Covidex Drug In Uganda
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 584 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Enrolled participants will be randomized to two trial arms. Arm1: the control arm will be composed of Standard of care for treating COVID-19 in Uganda as recommended by the ministry of Health plus the Placebo Arm 2: the Intervention arm will be composed of the intervention plus the standard of care for treating COVID-19 in Uganda as recommended by the ministry of Health |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Masking Description: | Both the participant and study clinicians and other data collectors will be blinded |
| Primary Purpose: | Treatment |
| Official Title: | 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. |
| Estimated Study Start Date : | March 1, 2022 |
| Estimated Primary Completion Date : | November 30, 2022 |
| Estimated Study Completion Date : | December 31, 2022 |
Eligibility Criteria Of Covidex Drug In Uganda
Inclusion Criteria:
- 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 Criteria:
- 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.
The Arms and Interventions Of Covidex Drug In Uganda
Placebo Comparator: Standard of care plus placebo armWill contain standard of care plus placebo
Drug: COVIDEXCOVIDEXTm 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.
Experimental: Stanadard of care plus COVIDEX armWill contain the standard of care plus the intervention given for 3 times daily for seven days
Drug: COVIDEXCOVIDEXTm 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.
The Outcome Measures Of Covidex Drug In Uganda
Primary Outcome Measures :
- Safety primary outcome [ Time Frame: Daily for 30 days ]Incidence of severe adverse events of grade 3 and above Minimum score: 0, Maximum score: 4. The higher the score, the worse is the adverse event
- Efficacy primary outcome: [ Time Frame: Day 8 ]Clinical recovery as measured by the WHO COVID ordinal improvement score Minimum score:0, Maximum score: 8. The higher the score, the worse is the clinical recovery
Secondary Outcome Measures :
- SARS-CoV-2 antigen present in the nasopharynx [ Time Frame: Day 8 and day 14 ]SARS-CoV-2 antigen present in the nasopharynx
- SARS-CoV-2 viral load in the nasopharynx as measured by the CT values [ Time Frame: Day 8 and day 14 ]SARS-CoV-2 viral load in the nasopharynx as measured by the CT values
The Study Description Of Covidex Drug In Uganda
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 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.
The Detailed Description Of Covidex Drug In Uganda
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.
Contacts and Locations Of Covidex Drug In Uganda
| Makerere University Department of Pharmacology and Therapeutics | |
| Kampala, Uganda, 7072 | |
| Contact: JACKSON MUKONZO, PhD +256758113468 mukojack@yahoo.co.uk | |
| Contact: SANDRA NALUYIMA, Msc +256702954895 sannaluyima@yahoo.com | |
| Principal Investigator: Joseph Ngozi, MMED | |
| Sub-Investigator: Lydia Bunalema, PhD | |
| Sub-Investigator: Milton Mutto, PhD | |
| Sub-Investigator: Fred Kyeyune, PhD | |
| Sub-Investigator: Hellen Aanyu, MMED | |
| Sub-Investigator: Rose Muhindo, MMED | |
| Sub-Investigator: John Ssenkusu, PhD |
Informations About Covidex Drug In Uganda
The development comes a week after attempts were made to halt the distribution of the medicine that Ugandans were rushing for after several positive testimonies about its potency.Prof. Patrick Engeu Ogwang, a lecturer at Mbarara University of Science and Technology and also the founder of the drug, was forced to issue a statement saying no clinical studies have been carried out on the drug to determine its efficacy.According to Prof. Ogwang, the drug has only undergone laboratory tests on animals to determine active compounds and safety.The National Drug Authority has approved the use of COVIDEX as a supportive treatment in the management of viral infections.Mid this month, the NDA banned the use of the drug saying the developer, Professor Patrick Ogwang had not subjected it to the required approvals. For a locally manufactured drug to be approved by the NDA, it has to go through clinical trials among other requirements.The approval comes days after the drug authority cautioned the public against using the drug since it had not yet undergone necessary testing.If the drug undergoes randomised clinical trials and is tested on over 120 people, it could be a big breakthrough for the country as far management of COVID-19 is concerned, especially during this second wave where the country have registered over 37,000 infections and 400 deaths.According to Mbarara University, COVIDEX is one of several products including a hand sanitizer that have been developed as part of the university’s Pharm-Biotechnology Traditional Medicine Center (PHARMBIOTRAC).The drug is not the first that has been developed to tackle COVID-19. The Natural Chemotherapeutics Research Institute is in the process of developing a COVID-19 cure, UBV-01N. So far the drug has been used by 53 people and studies are ongoing.