On the rainy morning of 3rd March 2023, the CONAT trial enrolled its first participant. A 32- year-old male that presented with cough, sore throat, rhinorrhea, fever and generalized body weakness at the Mulago Out Patient department. Nasal and oral swabs subsequently confirmed that he had the SARS COV 2 virus more widely known as the Covid 19 virus. He thus qualified to be part of the study given he met the criteria and also gave consent to be studied. Following the rigorous trial processes, he was put into the intervention arm of the study, which is testing one of 2 locally formulated herbal remedies in the treatment of acute respiratory viral illnesses. Clinical Trial of Natural Therapeutics shortened as CONAT seeks to study the safety and effectiveness of TazCoV and Vidicine herbal investigational medicinal products. These are Ugandan made herbal medicines that have been used in the community for the treatment of Covid 19 however there was no proven evidence on whether they actually work and if there are no side effects associated with them. And so, this is where the CONAT trial comes in. It is the second trial testing natural products in the treatment of Acute respiratory viral infections in Uganda. The first was the UBV-01N trial that tested the effectiveness of a bee venom formulation in the treatment of Sars Cov 2 at the peak of the second wave of the disease in Uganda in mid-2021. Since it is the same group of scientists that conducted that trial, the lessons learnt from it were used to design the current CONAT trial. The CONAT trial has been in development for about 2 years and this was because the study protocol had to meet both local and international drug development standards. This included seeking the necessary approvals for the trial to take place including from 2 of the most important scientific bodies in Uganda: Uganda National Council of Science and Technology and National Drug Authority. Included in this process was also the prehuman testing of these herbal formulations, that is in vitro studies to assess viral clearance and toxicity and animal studies to further assess their safety. Therefore, in order for these herbal formulations to gain acceptance on both a local and global stage, all the rigours listed above and more had to be done so that the CONAT trial could take shape and lift off. All these processes also show all the collaborations that had and have to take place in order for this trial to go forward smoothly.
The Makerere University Lung Institute with Ass. Prof. Bruce J. Kirenga as Chief Investigator are taking lead in conducting the trial with a number of however there is a long list of collaborators including Ministry of Science, Technology and Innovation -Office of the President (STI-OP) who are the sponsors of the trial; Mulago National Referral Hospital where the trial is being conducted; Uganda Virus Research Institute (UVRI); Makerere University Biomedical research centre (MakBRC); College of Veterinary Medicine, Animal Resources and Biosecurity, Makerere University (COVAB); and finally the innovators of the herbal formulations Busitema University (TazCoV) and Kazire (Vidicine). Thus, the enrollment of this first participant was the culmination of a lot of preparatory work from a lot of active players.
It was a fulfilling moment for the collaborators as the first step in seeing this trial come to fruition. However as this was the first step, there are several more that need to be taken as the trial goes forward, including enrolling more participants, dealing with the challenges that come with a trial of this magnitude both foreseen and unpredicted. And also answering the key questions this trial is asking; do these herbal formulations work, do they make a difference in acute respiratory viral disease activity and are they safe to use for the public. Uganda already has several herbal formulations for different diseases that are trusted by the populace and yet have no scientific backing and so may instead be harming Ugandans. This was evidenced during the Covid 19 pandemic where there was widespread use of herbal medicines. Therefore, the main goal for this trial is to be able to test more Ugandan made herbal formulations with a vision of placing those that have proven efficacy and safety on both Ugandan and international pharmacy shelves.
Compiled by Dr. Maria Sekimpi, CONAT Trial Manager