Larazotide for Long COVID

Recruiting at 1 trial location

Overseen By Lauren Guthrie, MPH

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Pregnancy, Unstable conditions, Liver, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Larazotide to determine if it can help people with Long COVID, which includes ongoing symptoms like fatigue, headaches, or trouble thinking clearly, even weeks after a COVID infection. Participants will receive either Larazotide or a placebo (a pill with no active medicine) for 21 days to assess the treatment’s safety and effectiveness. Suitable candidates have had a confirmed COVID infection and continue to experience lingering symptoms like tiredness or chest pain at least four weeks after. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Larazotide Acetate is likely to be safe for humans?

Research has shown that Larazotide has been tested for safety in children with COVID-19. The results indicated it was generally well-tolerated, with most participants not experiencing major problems. Some mild side effects occurred, but nothing serious was reported.

Larazotide strengthens the body's barriers, reducing inflammation by preventing harmful substances from passing through intestinal walls.

Since this trial is in an early stage, Larazotide has shown some safety in previous studies, but researchers are still gathering more information. If the medication is already approved for another use, it might suggest general safety, but it remains important to assess its effectiveness specifically for Long COVID. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Long COVID?

Unlike other treatments for Long COVID, which often focus on managing symptoms with existing medications, Larazotide Acetate offers a novel approach by targeting the gut barrier. Researchers are excited about Larazotide because it works by modulating tight junctions in the gut, potentially reducing inflammation and improving gut permeability. This mechanism is distinct from typical treatments that primarily address respiratory or cardiovascular symptoms, offering hope for a more comprehensive solution to the lingering effects of Long COVID. Additionally, Larazotide is administered orally, making it non-invasive and easy to incorporate into daily routines.

What evidence suggests that Larazotide might be an effective treatment for Long COVID?

Research has shown that Larazotide, a type of medication, helps maintain the integrity of the gut lining. This action may reduce symptoms in conditions like Long COVID by limiting the movement of harmful substances. Early findings suggest that Larazotide might aid in clearing viral particles and support recovery. In studies with children who have MIS-C, a COVID-19-related condition, Larazotide improved stomach issues more quickly. This trial will evaluate Larazotide's effectiveness in managing Long COVID symptoms, but further research is needed to confirm its benefits. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I've had worsening or new symptoms for over 4 weeks after a COVID-19 infection.

I've had ongoing or new symptoms for over 4 weeks after a COVID-19 infection.

I am between 7 and 21 years old.

Exclusion Criteria

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.

My liver tests are much higher than normal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive AT1001 or placebo orally four times a day for 21 days. Visits occur weekly with data and/or specimen collection.

3 weeks

1 visit (in-person), 2 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment with two virtual follow-up visits.

5 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Larazotide Acetate
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Larazotide Acetate (AT1001) Experimental Treatment 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Boston Children's Hospital, Boston, MA, USA

Collaborator

Trials

4

Recruited

2,600+

Published Research Related to This Trial

In a study involving 73 gastrointestinal cancer patients, the combination of megestrol acetate and ibuprofen significantly reversed weight loss, with patients gaining a median of 2.3 kg compared to a loss of 2.8 kg in the placebo group over 12 weeks.

Patients receiving megestrol acetate with ibuprofen also reported improved quality of life, as indicated by better EuroQol-EQ-5D scores, suggesting that this combination therapy may enhance both weight and overall well-being in advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized study of megestrol acetate and ibuprofen in gastrointestinal cancer patients with weight loss. McMillan, DC., Wigmore, SJ., Fearon, KC., et al.[2018]

A study involving 12 advanced-cancer patients found that the bioequivalence of megestrol acetate in tablet and sachet forms was similar, with intersubject variability being the main factor affecting pharmacokinetics rather than the formulation itself.

Although there was a trend suggesting higher bioavailability for the sachet formulation, this difference was not statistically significant, indicating that both forms can be considered equivalent in terms of efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic evaluation of two different formulations of megestrol acetate in patients with advanced malignancies. Camaggi, CM., Strocchi, E., Martoni, A., et al.[2018]

Megestrol acetate (MA) has been evaluated in major clinical trials for its effectiveness in treating cachexia, a condition characterized by weight loss and muscle wasting in various diseases.

The newly approved nanocrystal formulation of MA may enhance the delivery and efficacy of this medication, potentially improving treatment outcomes for patients suffering from cachexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Megestrol acetate in cachexia and anorexia. Yeh, SS., Schuster, MW.[2019]

In a study of 255 patients with advanced hormone-insensitive cancer, megestrol acetate (MA) significantly improved appetite and helped prevent further weight loss compared to placebo, especially noticeable at 4 weeks.

Despite these benefits, MA did not improve overall quality of life (QoL) and was associated with a decline in physical function by 12 weeks, with no impact on survival and only mild side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Megestrol acetate in advanced, progressive, hormone-insensitive cancer. Effects on the quality of life: a placebo-controlled, randomised, multicentre trial. Westman, G., Bergman, B., Albertsson, M., et al.[2019]

In a study of 22 patients with advanced cancer and significant weight loss, megestrol acetate (MA) oral suspension improved quality of life in a majority of patients, with 63% showing improvement after 2 weeks, and 55% after 8 weeks of treatment.

The most notable effect was on appetite, with 95% of patients reporting increased appetite after just 2 weeks of therapy, indicating that MA is a well-tolerated and effective palliative treatment for cancer-related anorexia/cachexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. Tomíska, M., Tomisková, M., Salajka, F., et al.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05747534

NCT05747534 | 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8860335/

Zonulin Antagonist, Larazotide (AT1001), As an Adjuvant ... Larazotide, a zonulin inhibitor, prevents breakdown of tight junctions, limiting antigen trafficking.

3. trialx.com trialx.com/clinical-trials/listings/282413/at1001-for-the-treatment-of-long-covid/

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 young adults 7 ...

4. science.org science.org/doi/10.1126/scitranslmed.adu4284

Viral spike antigen clearance and augmented recovery in ... Here, we present data from a phase 2a double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of larazotide ...

5. pharmacytimes.com pharmacytimes.com/view/larazotide-safe-effective-in-children-with-covid-19-related-mis-c

Larazotide Safe, Effective in Children With COVID-19- ... According to the authors, in patients with MIS-C treated with larazotide, there was an observed faster resolution of gastrointestinal symptoms, ...

6. ctv.veeva.com ctv.veeva.com/study/at1001-for-the-treatment-of-long-covid

AT1001 for the Treatment of Long COVID - ClinicalTrials.Veeva The primary objective of this study is to evaluate the safety and efficacy of Larazotide (AT1001) versus placebo in children and adults 7 to ...

7. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/pediatric_long_covid_clinical_trial

Long COVID Clinical Trial (7 to 50 year-olds) We are studying an oral medication called Larazotide to see if it is helpful in reducing symptoms of Long COVID in children and adults.