Clinical Trial of Natural Therapeutics for COVID-19 and Other Acute Respiratory Viral Infections

NCT ID: NCT05897203

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 510 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-03
• Study Completion Date: 2024-01-31

Brief Summary

The trial "Safety, Pharmacokinetics and Preliminary Efficacy of herbal products for the treatment of acute respiratory viral infections including SARS-CoV2 in Uganda; Phase 2A Open Label Clinical Trial" is currently being implemented under the Clinical Trials of Natural therapeutics Program. The trial sample size is 510, and the participants include adults (18 years or more) who fulfill the case definitions of acute respiratory infections (ARI), test positive for one of the target respiratory viruses, are negative for TB on GeneXpert; non-pregnant/non-breast-feeding females, have no history of hypersensitivity to any of the investigational products, and have given written consent to participate in the trial.

The overall objective of the trial is to assess the safety, pharmacokinetics and preliminary efficacy of TazCoV and Vidicine for the treatment of acute respiratory viral infections including (SARS-CoV2, RSV and Influenza A/B) in Uganda.

Primary objectives include:

1. To determine the safety and pharmacokinetics of TAZCOV and Vidicine herbal products among adult participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza A/B

2. To determine the extent of SARS-CoV2, RSV, and Influenza A/B viral clearance among adult participants patients with acute viral respiratory infection treated using TAZCOV and Vidicine

3. To establish time-to-remission of symptoms among participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine

4. To evaluate disease progression among participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine The end points include: Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events), days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment and time to presenting symptom resolution. The Pharmacokinetic endpoints include: the maximum concentration of IMP in plasma [Cmax], time taken for the IMP plasma concentration to reach maximum levels [Tmax] and time taken for the concentration of the IMP in the plasma or the total amount in the body to be reduced by 50%.

Conditions

Acute Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Investigational Medicinal product A (IMP A) + Standard of Care (SoC)

Participants in this arm will receive the both the Investigational medicinal product (IMP A) and the standard of care

Group Type: ACTIVE_COMPARATOR

TAZCOV

Intervention Type: DRUG

Herbal Syrup

Investigational Medicinal product B (IMP B) + Standard of Care (SoC)

Participants in this arm will receive the both the Investigational medicinal product (IMP B) and the standard of care

Group Type: ACTIVE_COMPARATOR

Vidicine

Intervention Type: DRUG

Herbal Syrup

Standard of care (SoC)

Participants in this arm will receive only the standard of care

Group Type: OTHER

TAZCOV

Intervention Type: DRUG

Herbal Syrup

Vidicine

Intervention Type: DRUG

Herbal Syrup

Interventions

TAZCOV

Herbal Syrup

Intervention Type: DRUG

Vidicine

Herbal Syrup

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• fulfill ARI case definition
• have signs and symptoms of ARI
• test positive for one of the target respiratory viruses (SARS-CoV2, RSV, or Influenza A/B)
• do not have symptoms suggestive of Pulmonary TB i.e cough for more than 2 weeks, drenching night sweats, evening fevers and marked weight loss.
• can provide informed consent or have a surrogate or legally appointed representative to give consent

Exclusion Criteria

• Severe acute respiratory illness (SARI)-defined as An acute respiratory illness with a history of fever or measured fever of ≥ 38 °C and cough and/or throat with onset within the past 10 days, requiring hospitalization or with SPO2≤92%
• History of hypersensitivity to the investigational product or components therein
• Conditions that may be regarded as contraindications to the investigational medicinal product include known allergic reactions and rashes to any herbal medicines and any untoward reactions to any herbal medications such as bleeding, headaches, high blood pressure, heart failure, seizures, agitation, etc.
• Severe organ impairment (liver, kidney, brain, heart)
• Inability to return for post-discharge follow-up
• Females who are pregnant or intend to become pregnant or are breastfeeding during the trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Makerere University Lung Institute

UNKNOWN

Sponsor Role: collaborator

MRC/UVRI and LSHTM Uganda Research Unit

OTHER

Sponsor Role: collaborator

Directorate of Government Analytical Laboratories

UNKNOWN

Sponsor Role: collaborator

Makerere University College of Veterinary Medicine, Animal Resources and Bio-security

UNKNOWN

Sponsor Role: collaborator

Makerere University Biomedical Research Centre

UNKNOWN

Sponsor Role: collaborator

Natural Chemotherapeutics Research Institute

UNKNOWN

Sponsor Role: collaborator

Makerere University

OTHER

Sponsor Role: lead

Responsible Party

Bruce J Kirenga

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mulago National Referral Hospital

Kampala, Central Region, Uganda

Site Status: RECRUITING

Countries

Uganda

Facility Contacts

Bruce Kirenga, PhD

Role: primary

brucekirenga@gmail.com

256782404431

Winters Muttamba, MPH

Role: backup

256772511261

Other Identifiers

CONAT

Identifier Type: -

Identifier Source: org_study_id