NE3107 for Post-COVID Syndrome

(ADDRESS-LC Trial)

Recruiting at 13 trial locations

Overseen By Peneolope Markham, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: BioVie Inc.

Disqualifiers: Recent vaccination, ICU admission, major illness

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well the drug NE3107 alleviates symptoms like brain fog and fatigue in individuals with Long COVID. Long COVID refers to persistent health issues following a COVID-19 infection. Participants will receive either NE3107 or a placebo to assess any improvement. Individuals who have experienced brain fog and fatigue for at least three months after a COVID-19 diagnosis may qualify for this study. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that NE3107 is likely to be safe for humans?

Earlier studies found that NE3107 was generally well-tolerated by adults. Most participants did not experience serious side effects. Some reported mild issues like headaches or stomach discomfort, but these were uncommon and short-lived.

NE3107 is currently in a Phase 2 study, indicating that earlier research has already assessed its safety in humans. This phase focuses more on its effectiveness, while still monitoring safety. So far, evidence suggests that NE3107 is safe for humans, with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Long COVID?

Unlike the standard treatments for post-COVID syndrome, which often focus on managing symptoms with medications like steroids or antivirals, NE3107 offers a fresh approach by targeting inflammation and insulin resistance. NE3107 is unique because it is an oral anti-inflammatory drug that works by inhibiting a specific protein involved in inflammation, potentially reducing both neuroinflammation and metabolic dysfunction. Researchers are excited about NE3107 because it could address the underlying causes of post-COVID symptoms rather than just alleviating them, offering hope for more effective and comprehensive relief.

What evidence suggests that NE3107 might be an effective treatment for Long COVID?

Research has shown that NE3107, which participants in this trial may receive, might help alleviate Long COVID symptoms such as brain fog and tiredness. NE3107 likely works by reducing long-term inflammation, a known cause of these symptoms. Early results suggest this could improve how patients feel and function. Although more information is needed, NE3107's potential to provide relief appears promising. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults who are experiencing persistent symptoms like 'brain fog' and fatigue after recovering from COVID-19, known as Long COVID. Participants will be required to take medication or a placebo twice daily and attend several clinic visits.

Inclusion Criteria

Agree to use birth control measures

Provide voluntary consent

Willing to allow blood collection

Exclusion Criteria

Medical history of major mental or physical illness prior to COVID-19 infection

I was in the ICU for COVID-19 treatment.

I received a COVID-19 vaccine in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take NE3107 or a placebo twice daily for 84 days

12 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 follow-up phone call

What Are the Treatments Tested in This Trial?

Interventions

• NE3107

Trial Overview The study is testing NE3107, a drug aimed at treating neurological symptoms associated with Long COVID. It involves comparing the effects of NE3107 against a placebo over an 84-day period with clinic visits and follow-up calls.

How Is the Trial Designed?

Group I: NE3107 Experimental Treatment 1 Intervention

One 20 mg capsule containing NE3107 taken by mouth twice daily (BID)

Group II: Placebo Placebo Group 1 Intervention

One 20 mg capsule containing placebo taken by mouth twice daily (BID)

Who Is Running the Clinical Trial?

BioVie Inc.

Lead Sponsor

Trials

8

Recruited

800+

Published Research Related to This Trial

Patients recovering from COVID-19, whether shortly after infection or long after (4-20 months), commonly experience pulmonary issues such as diaphragm dysfunction and dysfunctional breathing patterns, highlighting the need for diagnostic awareness.

A specialized rehabilitation program that includes respiratory therapy, muscular training, and psychological support significantly improves pulmonary recovery and helps most patients return to work, demonstrating its efficacy for both immediate and long-term post-COVID care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary recovery directly after COVID-19 and in Long-COVID. Altmann, CH., Zvonova, E., Richter, L., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06847191

Study Details | NCT06847191 | NE3107 in Adults With ... This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20586927

A Study of Bezisterim (NE3107) in Adults with Long COVID The purpose of this study is to evaluate the efficacy, safety, and tolerability of bezisterim (NE3107) oral capsules compared with matching placebo, in adult ...

3. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/BIVI/pressreleases/35742890/biovie-incs-ne3107-a-promising-study-for-long-covid-relief/

BioVie Inc.'s NE3107: A Promising Study for Long COVID ... The study aims to assess the effectiveness of NE3107 in alleviating neurological symptoms such as brain fog and fatigue in individuals suffering ...

4. digitalcommons.onu.edu digitalcommons.onu.edu/cgi/viewcontent.cgi?article=1199&context=paw_review

FDA Greenlights Early-Stage Trial for Investigational Long ... Bezisterim's ability to modulate chronic inflammation offers promising potential to alleviate these symptoms and improve patient outcomes. The ...

5. withpower.com withpower.com/trial/phase-2-post-acute-covid-19-syndrome-1-2025-223ed

NE3107 for Post-COVID Syndrome (ADDRESS-LC Trial) A specialized rehabilitation program that includes respiratory therapy, muscular training, and psychological support significantly improves pulmonary recovery ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06847191?cond=Post-Acute%20COVID19%20Syndrome&limit=100&aggFilters=status:rec&rank=43

NE3107 in Adults With Neurological Symptoms of Long ... Long COVID is a condition where debilitating symptoms can persist for months after a COVID-19 infection. This study aims to evaluate the effects of NE3107 on ...

7. ctv.veeva.com ctv.veeva.com/study/ne3107-in-adults-with-long-covid

NE3107 in Adults With Neurological Symptoms of Long COVID This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or ...

8. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/579016

NE3107 in Adults With Neurological Symptoms of Long COVID This study aims to evaluate the effects of NE3107 on several neurological symptoms reported in people with Long COVID including difficulty concentrating or ...