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Protease Inhibitor
Upamostat for COVID-19 Prophylaxis (PROTECT-APT 1 Trial)
Phase 2
Recruiting
Led By Kristen Pettrone, MD
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 7, 14, 28, week 8, and week 12
Awards & highlights
PROTECT-APT 1 Trial Summary
This trial is testing investigational products for safety & effectiveness against SARS-CoV-2. It's randomized, double blind & adaptive.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Specific side effects of Upamostat aren't detailed here, but clinical trials typically monitor for any adverse reactions ranging from mild (like headaches or nausea) to severe (such as allergic reactions). Placebos generally have no active ingredients so side effects are less likely.
PROTECT-APT 1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 7, 14, 28, week 8, and week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 7, 14, 28, week 8, and week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Early Treatment: Time to sustained alleviation or resolution of COVID-19 symptoms
Post-Exposure Prophylaxis: Incidence of symptomatic COVID-19 by Day 14
Secondary outcome measures
Early Treatment Upamostat Arm: Change in overall COVID-19 symptom severity score
Early Treatment Upamostat Arm: Comparison of active and placebo treatment groups in time to negative PCR
Early Treatment Upamostat Arm: Number and proportion of participant deaths (all cause)
+6 moreOther outcome measures
Early Treatment Upamostat Arm: Comparison between active and placebo treatment groups in proportion of all and greater than or equal to grade 3 adverse events.
Early Treatment Upamostat Arm: Difference in proportion of participants meeting the primary endpoint between treatment and placebo by variant of concern (VOC) via viral genome sequencing.
Early Treatment Upamostat Arm: Incidence of AEs causing IP discontinuation
+6 morePROTECT-APT 1 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Early Treatment: Upamostat 400 mgExperimental Treatment1 Intervention
400 mg (2 x 200 mg) capsules administered orally once daily for 14 days
Group II: Early Treatment: Placebo Oral CapsulePlacebo Group1 Intervention
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 Location
Who is running the clinical trial?
Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
92 Previous Clinical Trials
92,589 Total Patients Enrolled
4 Trials studying COVID-19
729 Patients Enrolled for COVID-19
Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling BiotechnologiesOTHER_GOV
1 Previous Clinical Trials
500 Total Patients Enrolled
1 Trials studying COVID-19
500 Patients Enrolled for COVID-19
RedHill Biopharma LimitedIndustry Sponsor
19 Previous Clinical Trials
2,770 Total Patients Enrolled
3 Trials studying COVID-19
785 Patients Enrolled for COVID-19
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using supplemental oxygen.I am currently on or will start taking blood thinners like warfarin, apixaban, or rivaroxaban.I have two or more symptoms that are moderate to severe.I tested negative for COVID-19 recently.I am an adult with symptoms seeking care or testing for COVID-19.I tested positive for COVID-19 recently.I have a heart condition that affects my heartbeat's rhythm.I have health conditions that could make COVID-19 worse for me.My symptoms started 5 days or less before signing up.I tested positive for COVID-19 between 6 to 90 days ago.My symptoms have been linked to COVID-19 by a doctor.I have been vaccinated for COVID-19 within the last 90 days, unless I have a severe immune condition or vaccines don't work on me.I am 18 years old or older.I was near someone with the illness for 15 minutes or more without wearing protective gear.
Research Study Groups:
This trial has the following groups:- Group 1: Early Treatment: Upamostat 400 mg
- Group 2: Early Treatment: Placebo Oral Capsule
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Early Treatment: Upamostat 400 mg a safe medication?
"According to our assessment at Power, Upamostat 400 mg was allocated a score of 2 on the safety scale due to Phase 2 trial status. This indicates there is evidence that supports its security but none for efficacy."
Answered by AI
How many sites can we expect to find this research project functioning at?
"Participants in this trial are being recruited from 6 diverse sites, including Abidjan, Bouaké and Bloemfontein. To reduce travel demands on participants, it is advisable to select the location closest them when enrolling."
Answered by AI
Are there currently any vacancies for participants of this research?
"Unfortunately, this medical trial is no longer recruiting patients. Initially posted on September 1st 2023 and last edited July 19th 2023, the experiment has reached its max number of participants. However, there are still 774 other clinical trials seeking volunteers at this time."
Answered by AI
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