Other Clinical Trial - AT1001 for the Treatment of COVID-19 Related MIS-C

Status Terminated

Clinical Trial Summary

The primary aim of this study is to evaluate the efficacy and safety of AT1001 versus placebo in pediatric patients with SARS-CoV-2 infection who experience early signs of MIS-C and are at high risk of progression. AT1001 10 μg/kg/dose up to 500 μg/dose (rounded to the nearest 50 μg) or matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.

Clinical Trial Description

This is a Phase 2a (Proof of Concept), randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of AT1001 for use in hospitalized pediatric patients diagnosed with MIS-C. Eligible participants (N=20) will be treated with AT1001 or matching placebo orally four times a day (QID) for up to 21 days as an add-on to standard of care. The study includes three phases: - Screening/Baseline: The main purpose of this phase is to determine if the participant meets entry criterion after obtaining informed consent and obtain baseline assessments. - Treatment: Eligible participants will be treated with AT1001 or matching placebo 10 μg/kg/dose QID up to 500 μg/dose (rounded to the nearest 50 μg) for 21 days as an add-on to standard of care for MIS-C. - Follow-up through 24 weeks: The participant will return for a follow-up visits during weekly clinic visits during Week 1 through Week 3, with monthly telemedicine visits at Week 4, Week 8, Week 16 and Week 20, and clinic visits at Week 12 and Week 24. Safety monitoring, including physical examination, vitals, and clinical laboratory testing will be performed during the screening phase, periodically during treatment phase and at the follow-up phase. Adverse events and concomitant medications will be recorded during the entire study. Total duration of the participants' participation in the study is approximately 24 weeks (with 21 days treatment period). Total duration of the study is projected to be 12 months, dependent on enrollment timeline. ;

Study Design

Related Conditions & MeSH terms

COVID-19
Covid19
Multisystem Inflammatory Syndrome in Children
Syndrome

Clinical Trial Details

NCT number	NCT05022303
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Terminated
Phase	Phase 2
Start date	October 1, 2021
Completion date	May 15, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05047692` - Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers	Phase 1
Recruiting	`NCT04395768` - International ALLIANCE Study of Therapies to Prevent Progression of COVID-19	Phase 2
Completed	`NCT04506268` - COVID-19 SAFE Enrollment	N/A
Terminated	`NCT04555096` - A Trial of GC4419 in Patients With Critical Illness Due to COVID-19	Phase 2
Completed	`NCT04508777` - COVID SAFE: COVID-19 Screening Assessment for Exposure
Completed	`NCT04961541` - Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine	Phase 1/Phase 2
Active, not recruiting	`NCT04546737` - Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients	N/A
Completed	`NCT04532294` - Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants	Phase 1
Terminated	`NCT04581915` - PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19	Phase 2/Phase 3
Terminated	`NCT04542993` - Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy	Phase 2
Not yet recruiting	`NCT04543006` - Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19	N/A
Completed	`NCT04494646` - BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)	Phase 2
Completed	`NCT04537663` - Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults	Phase 4
Completed	`NCT04387292` - Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Not yet recruiting	`NCT04527211` - Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel	Phase 3
Completed	`NCT04979858` - Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask	N/A
Not yet recruiting	`NCT05038449` - Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19	N/A
Completed	`NCT04610502` - Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients	Phase 2
Active, not recruiting	`NCT06042855` - ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.