NE3107 in Adults With Neurological Symptoms of Long COVID (ADDRESS-LC)

BioVie

Status and phase: Enrolling; Phase 2

Conditions: Long COVID

Treatments: Drug: NE3107; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06847191

CDMRP-PR230631 (Other Grant/Funding Number)

NE3107-LC-201

Details and patient eligibility

About

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

Enrollment: 208 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 18 years to 69 years of age

• Long COVID with neurological symptoms as defined below:

  1. Current symptoms of at least fatigue and neurocognitive impairment that began or worsened after an index SARS-CoV-2 infection that occurred at least 3 months prior to screening. Index SARS-CoV-2 infection is defined as either: 1) an episode of COVID-19 with a positive nucleic acid or antigen test during acute illness, as documented in the medical record, or 2) a documented clinical diagnosis of COVID-19, which can be based on a patient-reported positive test for COVID-19. Note that a documented diagnosis of Long COVID is not required for inclusion.
  2. Symptoms cannot be explained by any concomitant condition or diagnosis, in the opinion of the investigator.
  3. Symptom duration for at least 3 months. diagnosed with Long COVID with symptoms of fatigue and brain fog for at least 3 months

• Agree to maintain any other regular medications at current doses for the duration of the trial (except for essential need of new medication or dose change, as prescribed by a physician)

• Agree to use birth control measures

• Provide voluntary consent

• Willing to allow blood collection

• Pass all screening tests and procedures

Key Exclusion Criteria:

• Has received a COVID-19 vaccination within 14 days
• Previous admission to the intensive care unit for COVID-19
• Medical history of major mental or physical illness prior to COVID-19 infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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208 participants in 2 patient groups, including a placebo group

NE3107

Experimental group

Description:

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

Treatment:

Drug: NE3107

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo