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A clinical trial is a specific type of study that investigates the impacts of a specific treatment on a certain group of patients. This type of study consists of one group receiving a specific treatment (intervention group) compared to a group receiving normal treatment (control group). The goal is to determine if the intervention group shows any advantages over the control group.
You may find more information on clinical studies here:
Learn about Clinical Trials
This study aims to find out if a new medicine called FX06 can help patients with a condition called Acute Respiratory Distress Syndrome (ARDS). We want to see if FX06 can improve oxygenation in patients with ARDS and if the use of FX06 can reduce the duration of mechanical or assisted breathing as well as overall inflammation.
FX06 is a medication that stabilises the blood vessels in the lungs. During ARDS, the blood vessels in the lungs break apart, leading to an impaired ability to transfer oxygen to the cells. Stabilising these blood vessels would hopefully improve the ability to transfer oxygen to the red blood cells, and in turn, help to transport oxygen to the vital organs.
All clinical trials have rules about who can and cannot participate. These rules are called “eligibility criteria” but may also be referred to as inclusion/exclusion criteria. The criteria are based on factors such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. The eligibility criteria define the patient population that is being studied and are designed to protect the safety of participants in the trial. Because of the criteria, not everyone will qualify to participate in the trial.
Pregnant participants and those who are breastfeeding cannot join the study. We want to make sure everyone’s safety is our top priority.
The study duration for individual patients will be maximally 28 days (plus up to 2 days screening period) for the main study period, with a follow-up telephone call at day 60.
During the course of treatment, an IV catheter should be in place, and patients will be receiving medications accordingly. Participants in the study will receive the FX06 medication in the same IV catheter, and no new catheter needs to be placed. This means that participants will continue to receive standard-of-care treatment independent of study participation or study treatment group. The safety profile of FX06 has been demonstrated in phase 1 and phase 2 studies, and no participants in those studies experienced any adverse effects of FX02. However, as FX06 is still in the early stages of testing, the precise safety profile is still to be determined. Should the medical team detect any adverse reactions to FX06, the medication can be stopped, and participant health will be closely monitored.
Yes, patients in the COVend study will be treated either with the new drug FX06 or with a placebo twice a day. Neither the participant nor the treating physician will know if they receive FX06 or a placebo. Participants will be randomly assigned to one of two treatment groups in a 2:1 ratio, meaning that two out of three patients receive FX06 and one in three receives the placebo.
Participants will be randomly assigned to receive either FX06 or a placebo (a benign substance such as saline water). Physicians will closely monitor the participant’s health and check how they’re doing and ask follow up questions during this time.
If a potential participant has currently been in another study with an investigational medicine (IMP) or participated in one within the last 30 days, they won’t be able to join this trial. Safety is our priority.
During the course of treatment, participants will already have an IV catheter in place, and will be receiving medications accordingly. The FX06 medication can be given in the same IV catheter, and no additional catheter needs to be placed.
After hospital discharge, ongoing monitoring of participant progress will be conducted. Regular check-ins are scheduled every few days to assess participant well-being. On day 60, a follow-up conversation via phone or video will be arranged to ensure continued recovery.
In the event that participants choose to exit the study before day 6, they may still remain enrolled. As long as they have received a minimum of one dose of the study medication, their status will not be classified as “dropouts” from the study.
After the first assessment, there will be personal visits on days 1-6, 10, and 28. If participants are at home, assessments can be conveniently conducted over the phone or video. Doctors will ask after the participant’s breathing, any other medicines they’re taking, and if any new health concerns have arisen.
Participation in the study is voluntary, participants can withdraw at any time.
All the information collected from participants during the COVend study will be kept confidential, securely encrypted and not used for purposes other than the COVend project.
The COVend study has been approved by the National Committees for Medical and Health Research Ethics. Our utmost priority is to ensure participants’ comfort throughout their involvement. However, if there are any concerns or complaints about the study, please feel free to contact the project coordinator at: [email protected]
Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.
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