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

48 Participants Needed

Trial Summary

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.

What makes Larazotide Acetate unique for treating Long COVID?

Larazotide Acetate is unique for Long COVID as it is being explored for its potential to address gut barrier dysfunction, which is not a focus of standard treatments for this condition. This drug works by tightening the junctions between cells in the gut lining, potentially reducing inflammation and symptoms associated with Long COVID. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing Larazotide, an oral medication, in young individuals with Long COVID symptoms. The medication aims to strengthen the gut barrier to help reduce these symptoms.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A prospective randomized study of megestrol acetate and ibuprofen in gastrointestinal cancer patients with weight loss. [2018]

2. Slovakia pubmed.ncbi.nlm.nih.gov

Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. [2015]

3. England 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. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic evaluation of two different formulations of megestrol acetate in patients with advanced malignancies. [2018]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Megestrol acetate in cachexia and anorexia. [2019]