NCT05897203: CONAT

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

Status unknown Phase 2 Last updated 8 June 2023

What this trial tests

Phase 2 trial testing TAZCOV in Acute Respiratory Infection in 510 participants. Status unknown.

Timeline

3 March 2023

Primary endpoint
1 January 2024

1 January 2024

Quick facts

Lead sponsor	Makerere University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	510
Start date	3 March 2023
Primary completion	1 January 2024
Estimated completion	1 January 2024
Sites	1 location across Uganda

Drugs / interventions tested

• TAZCOV — full drug profile →
• Vidicine — full drug profile →

Conditions studied

• Acute Respiratory Infection — all drugs for Acute Respiratory Infection →

Sponsor

Makerere University

Who can join

Adults 18 to 70, any sex, with Acute Respiratory Infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events).
  Time frame: 9 months
  The outcome measures are cumulative incidences of solicited and unsolicited side effects (mild, moderate, severe adverse events) in the study arms
• Time to presenting symptom resolution
  Time frame: 14 days
  Will be assessed by time trends in clinical remission of signs and symptoms in the trial arms
• Days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment
  Time frame: 7 days
  Will be assessed through ascertaining the proportion with negative PCR on days 3, 5 and 7
• Progression to severe-critical ARI requiring hospitalization, oxygen therapy and/or mortality
  Time frame: 14 days
  To be measured by ascertaining the proportion progressing to severe ARI requiring hospitalization, oxygen therapy and/or mortality
• Time taken for TazCoV and Vidicine plasma concentration to reach maximum levels [Tmax]
  Time frame: 14 days
  To be measured by time to maximum concentration of TazCoV and Vidicine plasma \[Tmax\]

Sponsor's own description

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%.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.