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

Acute Respiratory Infection Clinical Trial

— CONAT  

Official title:

Safety, Pharmacokinetics, and Preliminary Efficacy of Herbal Products for the Treatment of Acute Respiratory Viral Infections Including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Uganda; Phase 2A Open Label Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05897203
• Other study ID #: CONAT
• Status: Recruiting
• Phase: Phase 2
• Start date: March 3, 2023
• Est. completion date: January 2024

Study information

• Verified date: June 2023
• Source: Makerere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria: ALl adults who

• 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

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Infections
• Respiratory Tract Infections
• Virus Diseases

Intervention

Drug:
• TAZCOV
Herbal Syrup
• Vidicine
Herbal Syrup

Locations

Country	Name	City	State
Uganda	Mulago National Referral Hospital	Kampala	Central

Sponsors (7)

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

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to presenting symptom resolution	Will be assessed by time trends in clinical remission of signs and symptoms in the trial arms	14 days
Primary	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
Primary	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
Primary	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