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Compares treatment options for Respiratory Viral Infection
Official title A Clinical Trial Evaluating the Safety and Efficacy of AP1189 Versus Placebo as an add-on to Standard of Care in Participants With Respiratory Insufficiency Expected to be Caused by Infection With Respiratory Viruses
ClinicalTrials.gov ID: NCT07633288
What this study is testing
What is AP1189, 100 mg?
AP1189, 100 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for respiratory viral infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A clinical study to evaluate the efficacy and safety of once daily oral dosing of 100 mg AP1189 or placebo administered for 14 days, as an add-on to standard of care (SOC) in participants with respiratory insufficiency expected to be caused by respiratory viral infection.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent has been obtained prior to initiating any study-specific procedures
- Expected respiratory viral infection, and positive for either SARS-COV-2, Influenza A or B, or RSV as confirmed by a bedside LAF test, qualitative...
- Hospitalized with respiratory insufficiency expected to be caused by respiratory viral infection defined by SpO2 ≤ 93 % on ambient air or...
- Duration of disease from first symptom\< 15 days before enrolment
- Females of childbearing potential using reliable means of contraception or are post-menopausal or are surgically sterilized
You likely can't join if
- In the investigator's opinion, progression to death is imminent and inevitable irrespective of the provision of treatment
- Already meeting any component of the primary composite endpoint at screening, defined as the presence of any of the following: invasive mechanical...
- Participating in other drug clinical trials
- Any condition that in the view of the screening physician would suggest that the participant is unable to comply with study protocol and procedures
- Participants who have initiated treatment within 3 months prior to screening with immunosuppressive or immunomodulatory treatments for chronic...
- Pregnant women or nursing (breastfeeding) mothers
See the full eligibility criteria
- Written informed consent has been obtained prior to initiating any study-specific procedures
- Expected respiratory viral infection, and positive for either SARS-COV-2, Influenza A or B, or RSV as confirmed by a bedside LAF test, qualitative PCR, or quantitative PCR (Q-PCR).
- Hospitalized with respiratory insufficiency expected to be caused by respiratory viral infection defined by SpO2 ≤ 93 % on ambient air or supplementary oxygen supply via nasal catheter or facial mask (WHO Clinical...
- Duration of disease from first symptom\< 15 days before enrolment
- Females of childbearing potential using reliable means of contraception or are post-menopausal or are surgically sterilized
- Females of childbearing potential with a negative pregnancy test at screening and baseline
- As the morbidity and mortality of respiratory infections are many fold increased in vulnerable participants, vulnerable participants are not excluded but included as subgroups.
- Screened within 24 hours of hospital admission to the hospital, or within 24 hours of receiving a patient, if the patient is transferred from another hospital or another hospital department due to respiratory distress
- In the investigator's opinion, progression to death is imminent and inevitable irrespective of the provision of treatment
- Already meeting any component of the primary composite endpoint at screening, defined as the presence of any of the following: invasive mechanical ventilation, ECMO, cardiovascular organ support (balloon pump or...
- Participating in other drug clinical trials
- Any condition that in the view of the screening physician would suggest that the participant is unable to comply with study protocol and procedures
- Participants who have initiated treatment within 3 months prior to screening with immunosuppressive or immunomodulatory treatments for chronic autoimmune diseases. Administration of steroids or other immunosuppressive...
- Pregnant women or nursing (breastfeeding) mothers
The study team makes the final eligibility decision.
Where it's taking place
- Mostar, Herzegovina-Neretva Canton, Bosnia and Herzegovina
- Banja Luka, Republika Srpska, Bosnia and Herzegovina
- Sarajevo, Sarajevo Canton, Bosnia and Herzegovina
- Podgorica, Podgorica Municipality, Montenegro
- Auckland, New Zealand
- Christchurch, New Zealand
- Wellington, New Zealand
- Niš, Nišava District, Serbia
- Užice, Zlatibor District, Serbia
- Belgrade, Serbia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mostar, Herzegovina-Neretva Canton, Bosnia and Herzegovina; Banja Luka, Republika Srpska, Bosnia and Herzegovina; Sarajevo, Sarajevo Canton, Bosnia and Herzegovina; Podgorica, Podgorica Municipality, Montenegro; Auckland, New Zealand; Christchurch, New Zealand and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.