The miR-AGE is a phase 2/3 study, in which phase 2 is done in participants that have a determined type of disease (in this case, Covid-19) and its objective is to verify the safety of medication being studied including the dose that can be taken/received, the response and the efficacy of the medication.
The phase 3 is also done in participants who have a determined type of disease (in this case, Covid-19), during this stage the medication being studied is compared to an existing standard treatment (in this case, the routine treatment of the clinic/hospital for Covid-19).
The number of participants in the phase 3 is larger compared to the number of participants in phase 2 and the main objective is to verify the relation between risk and benefit in the short and long-termand to evaluate the long-term effects of the medication (if any).
The study miR-AGE is being conducted in high-risk Covid-19 participants. This includes individuals with pre-existing conditions which are at higher-risk to develop the severe form of Covid-19. These conditions are: obesity, diabetes, hypertension, cardiac disease and/or are age 65 and older.
The study medication, ABX464, has already been studied for other indications in hundreds of other participants and may prevent the participants in the Covid-19 study from developing the severe form of disease.
This means that individuals more vulnerable to the Covid-19 disease who receive ABX464 may not develop the so-called acute respiratory distress syndrome, which requires admission to intensive care and oxygen therapy.
The patients will take one capsule orally once a day over 28 days, removing the need for hospitalization since the medication can be taken at home.
Participants enrolled in the study will be assisted by a responsible physician who will explain the details of the study, what they need to do and who will take care of them during the treatment.
During the mandatory quarantine of 14 days after a positive diagnosis of Covid-19, participants will be monitored by the responsible physician via telephone calls.
From the third week of treatment or from the moment the participant is released from quarantine by the doctor, participants will be required to go into the hospital for a few hours once a week and will be monitored by the responsible physician.
ABX464 has already been studied in over 300 participants and healthy volunteers for other treatment indications and it has shown a good and well tolerated safety profile.
ABX464 may cause some adverse events which were observed in participants and healthy volunteers for other treatment indications.
The following adverse events were observed in more than 10% of participants, all of them were mild to moderate: headache, nausea, vomits and gastrointestinal tract disorders (pain on superior abdomen).
The following adverse events were observed in less than 10% of the participants: diarrhea, fatigue (tiredness), edema (fluid retention or swelling), muscle and articulation pain, dizziness, fever, cutaneous eruption (rashes on the skin), itching and conjunctivitis.
As it occurs with every new medication in development, there is a possibility that other rare and unpredictable adverse events occur with ABX464 which have not occurred before and are not included in the list.