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Peptide
Larazotide for Long COVID
Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ongoing, worsening, new, or recurrent symptoms present ≥4 weeks after SARS-CoV-2 infection.Symptoms include but are not limited to fatigue, malaise, headache, cognitive impairment, neuropsychiatric symptoms, decreased exercise tolerance, post exertional malaise, dyspnea, cough, chest pain, palpitations, tachycardia, gastrointestinal symptoms, musculoskeletal symptoms, fever, lightheadedness, insomnia and other sleep disturbances, anosmia or dysgeusia, pain, paresthesia, menstrual cycle irregularities, erectile dysfunction
Age 7 to ≤21 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights
Study Summary
This trial will test a medication to help treat Long COVID in kids & young adults aged 7-21 who have SARS-CoV-2 antigenemia. AT1001 or placebo will be given QID for 21 days.
Who is the study for?
This trial is for children and young adults aged 7 to 21 with Long COVID symptoms persisting for at least 4 weeks post SARS-CoV-2 infection. Participants must have detectable spike protein in their blood, indicating ongoing antigenemia. Those with significant recent blood loss, liver or kidney dysfunction, pregnant or breastfeeding women, and those not using birth control are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Larazotide (AT1001) compared to a placebo in managing Long COVID symptoms. Half of the participants will receive AT1001 while the other half will get a placebo, both taken orally four times daily for three weeks.See study design
What are the potential side effects?
While specific side effects of Larazotide (AT1001) aren't listed here, common clinical trial side effects may include allergic reactions to ingredients, gastrointestinal issues like nausea or diarrhea, headaches, fatigue and potential impacts on liver or kidney function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had ongoing or new symptoms for over 4 weeks after a COVID-19 infection.
Select...
I am between 7 and 21 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Event Profiling and Time to Symptom Resolution
Secondary outcome measures
Cytokine profiling, Antigen Testing and Humoral and Cellular Responses
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Larazotide Acetate (AT1001)Experimental Treatment1 Intervention
Subjects will receive 250 or 500 µg of Larazotide Acetate orally four times a day (QID) for 21 days. Subjects <25.0 kg will receive 250 µg dose of Larazotide Acetate (AT1001), and subjects ≥25.0 kg will receive 500 µg dose of Larazotide Acetate (AT1001).
Group II: PlaceboPlacebo Group1 Intervention
Subjects will receive 250 or 500 µg of placebo orally four times a day (QID) for 21 days. Subjects <25.0 kg will receive 250 µg dose of placebo and subjects ≥25.0 kg will receive 500 µg dose of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Larazotide Acetate
2011
Completed Phase 2
~350
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,593 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had worsening or new symptoms for over 4 weeks after a COVID-19 infection.I have not donated more than 400 mL of blood in the last 3 months or more than 200 mL in the last month.I am a woman of childbearing age and agree to use birth control during the study.I've had ongoing or new symptoms for over 4 weeks after a COVID-19 infection.My liver tests are much higher than normal.My kidney function is reduced, with a filtration rate of 50 mL/min or less.I am between 7 and 21 years old.You have any detectable presence of certain parts of the COVID-19 virus in your blood.I am either 6 years old or younger, or older than 22.I cannot tolerate the drug due to side effects.You have had a confirmed COVID-19 infection based on a positive PCR or antigen test.
Research Study Groups:
This trial has the following groups:- Group 1: Larazotide Acetate (AT1001)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the criteria for participating in this experiment?
"For inclusion in this trial, applicants must have long covid syndrome and be aged between 7 to 21 years old. Thus far, 48 participants have been recruited for the study."
Answered by AI
Can participants join this experiment presently?
"According to the information present on clinicaltrials.gov, this particular research trial is not presently recruiting participants. It was first posted in March of 2023 and last updated at the end of February that same year. However, there are 853 other medical studies currently open for enrollment."
Answered by AI
Are octogenarians being welcomed as participants in this investigation?
"This clinical trial's enrolment requires that patients are between the ages of 7 and 21. For those under 18 there are 116 registered studies, whereas for individuals 65 years of age or older, there is a total of 743 trials available."
Answered by AI
Have the authorities given their stamp of approval to Larazotide Acetate (AT1001)?
"Our experts at Power concluded that Larazotide Acetate (AT1001) is relatively safe, giving it a score of 2. This estimation was made as the drug has gone through Phase 2 trials, displaying some evidence in support of safety but none for efficacy."
Answered by AI
Who else is applying?
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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