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.
试验速览
- 阶段
- 2 期
- 入组人数
- 584
- 试验地点
- 1
- 主要终点
- Safety primary outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Both the participant and study clinicians and other data collectors will be blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard of care plus placebo arm
Will contain standard of care plus placebo
干预措施: COVIDEX (Drug)
Stanadard of care plus COVIDEX arm
Will contain the standard of care plus the intervention given for 3 times daily for seven days
干预措施: COVIDEX (Drug)
结局指标
主要结局
Safety primary outcome
时间窗: 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:
时间窗: 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
次要结局
- SARS-CoV-2 antigen present in the nasopharynx(Day 8 and day 14)
- SARS-CoV-2 viral load in the nasopharynx as measured by the CT values(Day 8 and day 14)
研究者
College of Health Sciences
Associate professor
Makerere University