Phase 2 Long COVID Trial, Recruiting NCT06511063 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Long COVID
Back to Long Covid

Phase 2 Long COVID Trial, Recruiting

NCT06511063
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older, of any gender
  • You are willing and able to sign a consent form and follow all study requirements for the full duration of the trial
  • You have been formally diagnosed with Long COVID by a doctor
  • You had a confirmed or suspected COVID-19 infection at least 6 months before contacting the study team
  • You have had Long COVID symptoms for at least 6 months
  • You have had at least one of the following symptoms for at least 6 months after your COVID-19 infection: headache, memory problems, insomnia, mood changes, chest pain, heart palpitations, shortness of breath, cough, muscle pain, joint pain, or stomach/digestive issues
  • You experience at least moderate fatigue, as measured by a specific fatigue scoring tool
  • You experience at least moderate "post-exertional malaise" — meaning your symptoms get significantly worse after physical or mental effort — as measured by a specific screening tool
  • Before getting COVID-19, your overall health score (measured by a quality-of-life scale) was 80 or above out of 100, and it is now 70 or below (confirm with trial site)

Who may not be able to join:

  • You have a pre-existing autoimmune condition (such as chronic Epstein-Barr virus, Multiple Sclerosis, or Hashimoto's Disease) that could affect immune system test results
  • You were diagnosed before 2020 with another post-infectious syndrome, such as Chronic Lyme disease or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
  • You have a documented history of vaccine injury
  • You have any other ongoing health condition that could affect immune system testing, as decided by the research doctor
  • You are HIV positive
  • You are currently taking the medications Truvada or Selzentry
  • You have taken certain medications within the past 6 weeks that are known to interact with Truvada or Selzentry — this includes a long list of drugs such as acyclovir, carbamazepine, diclofenac, rifampin, and several others (confirm the full list with the trial site)
  • You are currently taking any medication known to affect Epstein-Barr virus (EBV), such as acyclovir, valacyclovir, ganciclovir, famciclovir, or interferon
  • You have a known allergy to any ingredient in Truvada or Selzentry
  • You have had a fever or illness with fever in the 3 months before your baseline study visit
  • You have taken part in another clinical trial or received an experimental treatment within the past 6 months
  • You have a weakened immune system — for example, if you have had an organ transplant or are taking immune-suppressing medications such as steroids
  • You have a known history of active liver disease (other than a fatty liver), including hepatitis B or C, primary biliary cirrhosis, or liver failure
  • You are currently receiving kidney dialysis or have known kidney problems
  • You have a serious health condition that required or is expected to require hospitalization or surgery within 7 days of joining the study, or that is considered life-threatening
  • You have a mental health or other medical condition that the study doctor believes makes participation unsuitable for you
  • Your HIV status is unknown — you must complete HIV testing before joining the study
  • You have active or latent (hidden/inactive) hepatitis B — you must complete hepatitis B blood tests before joining
  • You have severe or uncontrolled problems with your kidneys, blood, digestive system, lungs, heart, or nervous system that the study doctor believes would put you at unacceptable risk
  • Your kidney function (measured by a specific calculation) falls below a certain level (confirm with trial site)
  • You have a history of bone fractures that were not caused by an injury
  • You have low phosphate levels in your blood at a moderate or higher level of severity (confirm with trial site)
  • Any of your screening test results show abnormal values at a moderate or higher level of concern (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: David Putrino, PhD, PT, Icahn School of Medicine at Mount Sinai

Phone: 212-241-8454

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 October 2024
Est. completion
1 November 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov