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

NCT05228626 | Unknown Phase 2 DMC

• 1 other identifier: SBS-2022-129
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

COVIDEX

Outcome Measures

Primary Outcomes (2)

• Safety primary outcome

  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

  Daily for 30 days

• Efficacy primary outcome:

  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

  Day 8

Secondary Outcomes (2)

• 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

Study Arms (2)

Standard of care plus placebo arm

PLACEBO COMPARATOR

Will contain standard of care plus placebo

Drug: COVIDEX

Stanadard of care plus COVIDEX arm

EXPERIMENTAL

Will contain the standard of care plus the intervention given for 3 times daily for seven days

Drug: COVIDEX

Interventions

COVIDEX DRUG

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.

Stanadard of care plus COVIDEX arm; Standard of care plus placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makerere University: lead
• Mbarara University of Science and Technology: collaborator

Study Sites (1)

Makerere University Department of Pharmacology and Therapeutics

Kampala, 7072, Uganda

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both the participant and study clinicians and other data collectors will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 8, 2022
• Study Start: March 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

UG (1)