Upamostat for COVID-19 Prophylaxis
(PROTECT-APT 1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness and safety of a new treatment called Upamostat for people with COVID-19 or those exposed to the virus. The treatment is designed to prevent COVID-19 in individuals who have been in close contact with someone infected or to treat those who have recently tested positive and are showing symptoms. Suitable participants include adults who have tested positive for COVID-19 within the last five days and have at least two moderate symptoms, such as a sore throat or headache, or adults who were in close contact with someone with COVID-19 and have not yet developed symptoms. As a Phase 2 trial, the research focuses on measuring how well the treatment works in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking or plan to start taking warfarin, apixaban (Eliquis), or rivaroxaban (Xarelto).
Is there any evidence suggesting that Upamostat is likely to be safe for humans?
Research shows that upamostat, the treatment under study, has been generally well-tolerated in past studies. One study found that it helped COVID-19 patients recover faster. Importantly, participants in that study did not experience severe side effects. This suggests that upamostat may be safe for people, but ongoing research will provide more information.12345
Why do researchers think this study treatment might be promising?
Unlike the standard of care for COVID-19, which often involves antiviral drugs like Remdesivir or monoclonal antibodies targeting the virus, Upamostat is unique because it works by inhibiting proteases crucial for the virus to replicate. This new mechanism of action means that Upamostat potentially stops the virus from spreading within the body at an earlier stage. Researchers are excited about Upamostat because it is an oral capsule, making it easier to administer and potentially more accessible than intravenous treatments. Additionally, its use as a prophylactic suggests it could prevent the onset of the disease, providing a proactive approach to managing COVID-19.
What evidence suggests that Upamostat might be an effective treatment for COVID-19?
In this trial, participants will receive either Upamostat or a placebo. Research has shown that Upamostat may help treat COVID-19. One study found that patients taking Upamostat had no hospitalizations, while those who did not take it did. Another study found that people recovered from severe COVID-19 symptoms in just 3 days on average. Upamostat works by blocking an enzyme that helps the virus spread in the body. These findings suggest that Upamostat could effectively manage COVID-19 symptoms and reduce the severity of the illness.34678
Who Is on the Research Team?
Danielle Clark, PhD
Principal Investigator
Henry M. Jackson Foundation for the Advancement of Military Medicine
Kristen Pettrone, MD
Principal Investigator
Henry M. Jackson Foundation for the Advancement of Military Medicine
Are You a Good Fit for This Trial?
This trial is for adults over 18 who've been in close contact with someone with confirmed COVID-19 or have mild symptoms within 5 days of onset. They must test negative initially but positive at enrollment, not be on oxygen therapy, and can't have had COVID-19 or a vaccine in the last 90 days unless immunocompromised.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Early Treatment
Participants receive Upamostat 400 mg or placebo orally once daily for 14 days
Post-Exposure Prophylaxis
Participants are monitored for incidence of symptomatic COVID-19
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Upamostat
Trial Overview
The PROTECT-APT 1 study tests Upamostat against a placebo as an early treatment and preventative measure for COVID-19. Participants are randomly assigned to receive either the drug or placebo without knowing which one they get, to compare safety and effectiveness.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
400 mg (2 x 200 mg) capsules administered orally once daily for 14 days
The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead Sponsor
Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies
Collaborator
RedHill Biopharma Limited
Industry Sponsor
FHI Clinical, Inc.
Collaborator
Citations
RedHill Announces Publication of Positive Phase 2 Study ...
Positive data from a U.S. Phase 2 study of once-daily oral RHB-107 (upamostat) in symptomatic COVID-19 published in the peer-reviewed ...
RedHill Biopharma Secures Allowance of Key Chinese ...
Further post-hoc analysis showed faster recovery periods from severe COVID-19 symptoms with a median of 3 days to recovery with RHB-107 compared ...
Phase 2/3 Study of Upamostat, a Serine Protease Inhibitor, ...
One medication, remdesivir, has shown efficacy in treatment of COVID-19 in hospitalized patients with severe illness; several monoclonal ...
RedHill Announces Positive Phase 2 Study Results with ...
Although not powered for efficacy assessment, the study showed highly promising efficacy results delivering a 100% reduction in hospitalization ...
Upamostat: a serine protease inhibitor for antiviral, ...
It has demonstrated preliminary evidence of efficacy against COVID-19, and nonclinical data suggest potential applicability against other viral illnesses, ...
Our Programs - Pipeline - RHB-107
RHB-107 successfully completed a Phase 2 study in non-hospitalized symptomatic COVID-19 patients which evaluated the safety and tolerability profile of RHB ...
A randomized, placebo-controlled pilot study of upamostat, ...
Conclusion: Upamostat was well tolerated, shortened recovery time, and decreased new severe symptoms and hospitalization. Keywords: COVID-19; ...
Mesupron (upamostat) / Heidelberg Pharma, RedHill
... COVID-19 Outpatient Study with RHB-107 (PRNewswire) - "RedHill Biopharma Ltd....announced that the first patient was dosed in its U.S. Phase 2/3 study of ...
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