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NCT05747534 · ClinicalTrials.gov registry record · Phase 2
AT1001 for the Treatment of Long COVID
A Phase 2 study of Long COVID and Post-Acute COVID-19 Syndrome, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 2
- Study locations
NCT05747534: Recruiting Phase 2 study of Long COVID and Post-Acute COVID-19 Syndrome, sponsored by Massachusetts General Hospital.
NCT05747534 is a Phase 2 study of Long COVID and Post-Acute COVID-19 Syndrome that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 150 participants, below the 2,185-participant average among 50 other Long COVID trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05747534, a Phase 2 study of Long COVID and Post-Acute COVID-19 Syndrome, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 2
- Study locations
Study Summary
The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and adults 7 to ≤50 years of age who present with symptoms of Long COVID in the presence of SARS-CoV-2 antigenemia. AT1001 (n=100) or placebo (n=50) will be administered orally four times a day (QID) for 21 days.
Primary Outcome
The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and young adults 7 to ≤50 years of age who present with symptoms of Long COVID. Safety will be assessed by means of adverse event monitoring, and efficacy will be evaluated using the Symptom Burden Questionnaire™ for Long COVID (SBQ™-LC) survey. Additional surveys will be used to monitor symptoms, quality of life and limitation of activities before, during and after treatm
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Larazotide Acetate
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-05-31 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
What NCT05747534 shows while recruiting
NCT05747534 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 2,185-participant average among 50 other Long COVID trials with a reported enrollment target (93% lower).
The record links to 4 conditions, with Long COVID appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05747534 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05747534 about?
NCT05747534 is a clinical study titled "AT1001 for the Treatment of Long COVID". The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and adults 7 to ≤50 years of age who present with symptoms of Long COVID in the presence of SARS-CoV-2 antigenemia. AT1001 (n=100) or placebo (n=50) will be administered orall...
What is the current status of trial NCT05747534?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2023-05-31. Estimated completion is 2027-03-31.
What conditions does trial NCT05747534 study?
This clinical trial studies the following conditions: Long COVID, Post-Acute COVID-19 Syndrome, Long COVID-19, Post Acute Sequelae of COVID-19.
What interventions are being tested in trial NCT05747534?
The interventions under investigation include: Placebo (DRUG), Larazotide Acetate (DRUG).
Who is sponsoring clinical trial NCT05747534?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05747534 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Long COVID
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05747534's enrollment target sits among peer trials
150 22nd of 50 higher than 28 of 50 other Long COVID trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Long COVID trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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