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

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Makerere University
• Collaborator: Mbarara University of Science and Technology

Criteria

Inclusion Criteria:

1. Provision of signed/thumb printed and dated informed consent form

2. Willingness to comply with all study procedures and availability over the study duration

3. Patients aged 18years and above

4. Positive SARS-CoV-2 antigen rapid test and/or PCR positive for SARS-Cov-2 (COVID-19)

5. 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:

1. Patients who report use of COVIDEX with-in three days prior to presentation to the hospital.

2. 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).

3. Pregnancy or breast feeding.

4. Current use of remdesivir and molnupiravir therapy.

5. Active participation in another clinical trial or using another drug on compassionate use such as fluvoxamide.

6. Very ill patients with multiple comorbidities where determination of clinical outcome will be difficult as judged by the attending physician.