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

NCT05897203 | Unknown Phase 2 DMC

• 1 other identifier: CONAT
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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

Outcome Measures

Primary Outcomes (5)

• Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events).

  The outcome measures are cumulative incidences of solicited and unsolicited side effects (mild, moderate, severe adverse events) in the study arms

  9 months

• Time to presenting symptom resolution

  Will be assessed by time trends in clinical remission of signs and symptoms in the trial arms

  14 days

• Days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment

  Will be assessed through ascertaining the proportion with negative PCR on days 3, 5 and 7

  7 days

• Progression to severe-critical ARI requiring hospitalization, oxygen therapy and/or mortality

  To be measured by ascertaining the proportion progressing to severe ARI requiring hospitalization, oxygen therapy and/or mortality

  14 days

• Time taken for TazCoV and Vidicine plasma concentration to reach maximum levels [Tmax]

  To be measured by time to maximum concentration of TazCoV and Vidicine plasma \[Tmax\]

  14 days

Study Arms (3)

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

ACTIVE COMPARATOR

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

Drug: TAZCOV

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

ACTIVE COMPARATOR

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

Drug: Vidicine

Standard of care (SoC)

OTHER

Participants in this arm will receive only the standard of care

Drug: TAZCOV; Drug: Vidicine

Interventions

TAZCOV DRUG

Herbal Syrup

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

Vidicine DRUG

Herbal Syrup

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Makerere University: lead
• Makerere University Lung Institute: collaborator
• MRC/UVRI and LSHTM Uganda Research Unit: collaborator
• Directorate of Government Analytical Laboratories: collaborator
• Makerere University College of Veterinary Medicine, Animal Resources and Bio-security: collaborator
• Makerere University Biomedical Research Centre: collaborator
• Natural Chemotherapeutics Research Institute: collaborator

Study Sites (1)

Mulago National Referral Hospital

Kampala, Central Region, Uganda

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: A phase 2A open-label randomized controlled clinical trial

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 9, 2023
• Study Start: March 3, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 2 years after trial end

Locations

UG (1)