Larazotide for Long COVID

Recruiting in Palo Alto (17 mi)

+1 other location

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Pregnancy, Unstable conditions, Liver, others

Prior Safety Data

Trial Summary

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.

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.

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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.

Trial 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)

Participant Groups

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.

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Children's Hospital Boston, MA

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital Lead Sponsor

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] The use of megestrol acetate in the treatment of weight loss in gastrointestinal cancer patients has been disappointing. The aim of the present study was to compare the combination of megestrol acetate and placebo with megestrol acetate and ibuprofen in the treatment of weight loss in such patients. At baseline, 4-6 weeks and 12 weeks, patients underwent measurements of anthropometry, concentrations of albumin and C-reactive protein and assessment of appetite, performance status and quality of life using EuroQol-EQ-5D and EORTC QLQ-C30. Thirty-eight and 35 patients (median weight loss 18%) were randomized to megestrol acetate/placebo or megestrol acetate/ibuprofen, respectively, for 12 weeks. Forty-six (63%) of patients failed to complete the 12-week assessment. Of those evaluable at 12 weeks, there was a decrease in weight (median 2.8 kg) in the megestrol acetate/placebo group compared with an increase (median 2.3 kg) in the megestrol acetate/ibuprofen group (P

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

Palliative treatment of cancer anorexia with oral suspension of megestrol acetate. [2015] Megestrol acetate (MA) is a progestational agent, currently known as one of the most effective appetite stimulants in patients suffering from cancer anorexia/cachexia syndrome. Oral suspension of this drug may be particularly useful in patients with far advanced disease, where taking larger amount of pills may lead to the decrease of patient compliance. The influence of oral MA suspension on quality of life and nutritional status was evaluated in 22 patients with far advanced cancer suffering from anorexia and more than 5 per cent weight loss, all beyond the scope of anticancer treatment. Most patients had lung or gastrointestinal cancer. QLQ-C30 questionnaire, visual analogue scale (VAS) for appetite, anthropometry, maximal handgrip strength and laboratory data were obtained before treatment and then after 2, 4, and 8 weeks of therapy. Despite of a known high mortality in this prognostically unfavorable group of patients (36% within two months in this study), overall quality of life after the daily dose of 480-840 mg of MA was improved in 63, 56, and 55% of patients remaining on therapy after 2, 4, and 8 weeks, respectively. Appetite was the most successfully influenced parameter with an improvement in VAS in 95% of cases after 2 weeks of therapy (p=0.0001). The drug was well tolerated by the great majority of patients. Oral suspension of megestrol acetate maybean effective palliative treatment for many patients with far advanced cancer suffering from anorexia/cachexia syndrome.

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] A randomised double-blind placebo-controlled multicentre trial was performed to investigate the effects of megestrol acetate (MA) on the quality of life (QoL), appetite, weight and survival of patients with advanced, incurable, hormone-insensitive cancer. QoL was assessed at the start of treatment and at 4, 8 and 12 weeks, using the EORTC-QLQ-C30 instrument. 255 patients were randomised to 320 mg of MA daily or placebo for 12 weeks. 244 patients were assessable at baseline, 190 at 4 weeks (placebo 94; MA 96), 150 at 8 weeks (placebo 69; MA 81) and 112 at 12 weeks (placebo 55; MA 57). A beneficial effect of MA on appetite loss was observed at week 4 (P

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

Pharmacokinetic evaluation of two different formulations of megestrol acetate in patients with advanced malignancies. [2018] The bioequivalence of two megestrol acetate formulations, 160-mg "tablets" and 160-mg "sachets," was investigated in a single-dose, open-label, balanced-for-sequence cross-over study involving 12 advanced-cancer patients. The observed plasma megestrol-acetate time course obtained with both formulations was consistent with the literature data. The main source of variability in the pharmacokinetic parameters was intersubject variability; drug formulation played only a minor (and nonsignificant) role. The width of the 90% confidence interval of the area-under-the-curve (AUC) ratio (sachets: tablets) computed according to Schuirmann (0.9-1.4) was mainly due to the presence of a single outlier, showing an AUC ratio of 2.7. The trend to higher bioavailability of the new formulation was not significant, especially as compared with the dose-response data reported in the literature.

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

Megestrol acetate in cachexia and anorexia. [2019] The aim is to review major clinical trials that have used megestrol acetate (MA) in the treatment of cachexia across several disease states. A review of general usage and potential side-effects are discussed. A theory that the newly approved nanocrystal formation of MA can better deliver this potent medication for treatment will also be reviewed.