NE3107 for Post-COVID Syndrome

(ADDRESS-LC Trial)

Recruiting at 5 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

Trial Summary

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.

How does the drug NE3107 differ from other treatments for post-COVID syndrome?

NE3107 is unique because it is a drug being investigated specifically for post-COVID syndrome, whereas other treatments like stem cell therapy and rehabilitation programs focus on broader recovery aspects. NE3107's novelty may lie in its specific mechanism of action, which could target inflammation or other pathways differently than existing therapies. ^{1 2 3 4 5}

What is the purpose of this trial?

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 several neurological symptoms reported in people with Long COVID including difficulty concentrating or remembering things ("brain fog") and fatigue. Researchers will compare NE3107 to a placebo (a look-alike substance that contains no drug) to see if NE3107 works to treat neurocognitive and fatigue symptoms of long COVID. Participants will: * Take NE3107 or a placebo twice daily for 84 days * Visit the clinic 5 times for checkups and tests and have a follow up phone call

Eligibility Criteria

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

I was in the ICU for COVID-19 treatment.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Determinants of long COVID among adults hospitalized for SARS-CoV-2 infection: A prospective cohort study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Association of BMI with general health, working capacity recovered, and post-acute sequelae of COVID-19. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Adipose-derived, autologous mesenchymal stem cell therapy for patients with post-COVID-19 syndrome: an intermediate-size expanded access program. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Pulmonary recovery directly after COVID-19 and in Long-COVID. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

COVID-19 Patients in the COVID-19 Recovery and Engagement (CORE) Clinics in the Bronx. [2023]