Phase 3 Long COVID Trial, Recruiting NCT06960928 Sponsor: Icahn School of Medicine at Mount Sinai Condition: Long COVID
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Phase 3 Long COVID Trial, Recruiting

NCT06960928
Recruiting Phase 3

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 sex
  • You are able to sign and date a consent form agreeing to take part
  • You are able to attend all study visits in person at 5 East 98th St, New York, NY
  • 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 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 problems
  • You experience at least moderate fatigue, as measured by a specific fatigue questionnaire
  • You experience at least moderate post-exertional malaise (worsening of symptoms after physical or mental effort), as measured by a specific screening tool
  • Your quality of health score was 80 or above before your COVID-19 infection, and is now 70 or below (measured by a survey before the study begins)
  • You are willing and able to follow all study procedures, attend appointments, and complete all required tests and surveys

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 testing results
  • You were diagnosed before 2020 with another post-infectious illness, such as Chronic Lyme Disease or Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
  • You have a documented history of a vaccine injury
  • You have had a lung or liver transplant
  • You have known liver or kidney problems
  • You weigh less than 40 kg (approximately 88 lbs)
  • You have any other long-term condition that could affect immune test results, as judged by the study doctor
  • You are currently taking a medication called sirolimus
  • You are currently taking certain medications that are known to interact with sirolimus — including some antibiotics, antifungals, heart medications, anti-seizure drugs, steroids, HIV medications, St. John's Wort, and grapefruit (confirm with trial site for the full list)
  • You are currently taking ACE inhibitors (a type of blood pressure medication)
  • You have had a fever or illness with fever within the last 3 months before your baseline study visit
  • You have taken part in another clinical trial or received an experimental treatment within the last 3 months before your baseline study visit
  • You have uncontrolled diabetes, unstable heart disease, significant lung disease, a history of immune deficiency, are receiving immune-suppressing treatment, have a blood clotting disorder or take long-term blood thinners, or have liver problems
  • You are pregnant or planning to become pregnant
  • You are currently breastfeeding

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 3: approximately ~65% 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, PT, PhD, Icahn School of Medicine at Mount Sinai

Phone: 212-241-7658

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 3
Registry
ClinicalTrials.gov
Start date
18 April 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

European Quality of Life-Visual Analogue Scale (EQ-VAS)

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