Upamostat for COVID-19 Prophylaxis

(PROTECT-APT 1 Trial)

Recruiting at 8 trial locations

Overseen By Zen Hafy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine

Must not be taking: Warfarin, Eliquis, Xarelto

Disqualifiers: Hospitalization, Severe immunocompromise, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

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).

What is the purpose of this trial?

This study is an adaptive, randomized, double blind, platform trial evaluating promising investigational products (IP) for safety and efficacy as early outpatient treatment and post-exposure prophylaxis for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

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

Eligibility Criteria

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

Asymptomatic contact of an individual with laboratory confirmed SARS-CoV-2 infection

I have two or more symptoms that are moderate to severe.

I tested negative for COVID-19 recently.

Exclusion Criteria

Pregnancy

Breastfeeding

I am using supplemental oxygen.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Treatment

Participants receive Upamostat 400 mg or placebo orally once daily for 14 days

2 weeks

Daily follow-up via symptom questionnaire

Post-Exposure Prophylaxis

Participants are monitored for incidence of symptomatic COVID-19

2 weeks

Daily follow-up via symptom questionnaire

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Weekly follow-up via symptom questionnaire

Treatment Details

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.

Participant Groups

Group I: Early Treatment: Upamostat 400 mg Experimental Treatment 1 Intervention

400 mg (2 x 200 mg) capsules administered orally once daily for 14 days

Group II: Early Treatment: Placebo Oral Capsule Placebo Group 1 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.

Who Is Running the Clinical Trial?

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

Trials

103

Recruited

94,300+

Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies

Collaborator

Trials

3

Recruited

1,000+

RedHill Biopharma Limited

Industry Sponsor

Trials

20

Recruited

2,700+

FHI Clinical, Inc.

Collaborator

Trials

2

Recruited

380+