A Clinical Trial During the COVID-19 Pandemic: Challenges and Opportunities
By Dr. Petra Schulz (left), Project Lead Clinical Development and Dr. Astrid Kaiser (right), Head of Drug Development, MetrioPharm
This is the fourth article within our series of six covering various aspects of work behind the scenes in the iMPAct project. In today’s article, Petra Schulz and Astrid Kaiser, describe the challenges that come with conducting a phase IIa clinical trial during the COVID-19 pandemic.
MetrioPharm’s Phase IIa trial for MP1032
In the Phase IIa trial, MetrioPharm aimed to evaluate safety and efficacy of their lead compound MP1032 as a treatment against COVID-19. This is done by comparing the drug against the standard of care. In preclinical trials, the drug has shown potent anti-viral effects.
As a project lead, Dr. Petra Schulz acts as the main contact for the Contract Research Organisation (CRO), the party carrying out the clinical trial on behalf of the sponsor, MetrioPharm. Petra Schulz, Astrid Kaiser and her colleagues at MetrioPharm have designed the trial, and it is their responsibility to oversee the work done at the CRO and at clinical trial sites.
What is a clinical trial?
Clinical trials are research studies with participants who give their consent . To streamline these studies, the European Medicines Agency (EMA) has set strict regulations and guidelines. Clinical trials typically follow three phases (see Figure 1). In Phase I, focus is on ensuring treatment safety. Phase II trials aim to find out the right dose regime (also called dose finding studies) and if the new treatment works well enough– this is called treatment efficacy and which population the treatment works for. This phase typically could follow a two-step approach: Phase IIa aims to find a proof of concept, using a small population of participants, where Phase IIb trials are the definite dose-finding studies, using a larger population.
Phase III is the last phase of a clinical trial before the drug has officially shown to work and has been approved. In this phase, the main objective is to show efficacy in a large population, to compare treatment with conventional therapies if available, and to find out more about its side effects.
Figure 1: Clinical trial design (taken from EMA). Before clinical studies can start the drug compound needs to be extensively tested in non-clinical studies to evaluate its mechanisms of action and pass several quality tests. Once clinical trials begin, they are split into phase 1-3, increasing the number of people participating. In phase 1 safety is the primary goal and in phase 2-3 where it is determined whether the endpoints are met. Source: EMA
Challenges of doing a clinical trial during a pandemic
Running a clinical trial is challenging, let alone running one during an ongoing pandemic. The biggest challenge Astrid Kaiser and Petra Schulz and their colleagues came across in the years of the pandemic was the uncertainty in participant involvement. Recruitment for studies during an ongoing pandemic is unpredictable and not linear as compared to clinical studies normally. “We could not calculate the real number of patients”. This is, because infection rates can go up and down quickly during the waves of a pandemic. “You have to be flexible in such a dynamic situation”, Dr. Petra Schulz adds.
In parallel, vaccines were being developed and administered, making the pool of hospitalised patients – possible participants for the iMPact project’s clinical trial – even smaller. This drop in recruitment was very challenging for the team.
Promising clinical trial results
The topline data from the Phase IIa trial in the iMPact project has again demonstrated a great safety profile of MP1032 with limited drug-related side effects. Furthermore, the MP1032 effect looks very promising in patients treated with the lead compound plus Standard of Care. MetrioPharm is currently evaluating the clinical trial results in more depths and the possibilities and opportunities to continue the development of MP1032 for COVID-19 treatment.
“On behalf of MetrioPharm and its project partners we would like to thank all the people involved in running the clinical trial and foremost the patients participating in the trial”, says Astrid Kaiser and her colleague Petra Schulz.
More information about the phase IIa trial and the results can be found in MetrioPharm’s press release published in December 2022.
Our next article: The role of communications within the iMPact project
In our next article Mark-Alexander Brysch, Content Director for the iMPact Project talks about the role of communication in clinical trial design and implementation. Communications around ongoing clinical trials and when results come in is challenging during normal circumstances, but particularly during a pandemic. Mark-Alexander Brysch will therefore touch upon how to manage expectations.