RECRUITING

Study of Xiflam™ Treatment in Patients Post COVID-19 Infection Suffering From What is Known as Long COVID (LC)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the safety and efficacy of Xiflam versus Placebo in patients who present with signs and symptoms of Long COVID. Xiflam (n=10) or placebo (n=5) will be administered orally once a day (QD) for 12 weeks.

Official Title

A Phase 2 Study to Compare the Efficacy and Safety of Orally Administered Xiflam™ Therapy With Orally Administered Placebo in Patients With Ocular and Systemic Manifestations of Post COVID Sequelae Known as "Long" COVID

Quick Facts

Study Start:2024-03-12

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06437223

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Have tested positive for COVID-19 irrespective of variant or timeframe. 2. Developed signs and symptoms of the disease as described by the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO). 3. Have recovered from the infection (tested negative for COVID-19). 4. Following negative COVID-19 testing, continued to demonstrate signs/symptoms which were not pre-existing. The signs/symptoms must have persisted for 12 weeks or more. 5. Have had a persistent recurrence of a disease state (e.g., posterior uveitis, extreme fatigue etc.) that occurred following COVID-19 infection. 6. Female subjects must be: 1. Women of non-child-bearing potential, or 2. Women of child-bearing potential with a negative pregnancy test at screening, must agree to use approved methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study. 7. Males with female partners of child-bearing potential must agree to use approved methods of contraception and agree to refrain from donating sperm for the duration of the study. 8. Willing and able to give informed consent and to comply with the study procedures and assessments.	1. No proof of having tested positive for COVID-19 infection at any time. 2. Presence of an active ocular/systemic disease that in the opinion of the Investigator existed prior to COVID-19 infection and is not likely a LC related condition. 3. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization. 4. History of laser therapy in the macular region. 5. Any ocular or systemic condition that in the opinion of the Investigator is not LC related (e.g., pre-existing cataract) that may require surgery or medical intervention during the study period. 6. Participation in any systemic experimental treatment or any other systemic investigational new drug within 90 days prior to the start of study treatment. 7. Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation. 8. Known hypersensitivity to Xiflam™ or excipients. 9. Known history of alcohol and/or drug abuse within 12 months prior to Visit 1 Screening that, in the opinion of the Investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.

Inclusion Criteria

Exclusion Criteria

1. Have tested positive for COVID-19 irrespective of variant or timeframe.
2. Developed signs and symptoms of the disease as described by the Centers for Disease Control and Prevention (CDC) and World Health Organization (WHO).
3. Have recovered from the infection (tested negative for COVID-19).
4. Following negative COVID-19 testing, continued to demonstrate signs/symptoms which were not pre-existing. The signs/symptoms must have persisted for 12 weeks or more.
5. Have had a persistent recurrence of a disease state (e.g., posterior uveitis, extreme fatigue etc.) that occurred following COVID-19 infection.
6. Female subjects must be:
1. Women of non-child-bearing potential, or
2. Women of child-bearing potential with a negative pregnancy test at screening, must agree to use approved methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
7. Males with female partners of child-bearing potential must agree to use approved methods of contraception and agree to refrain from donating sperm for the duration of the study.
8. Willing and able to give informed consent and to comply with the study procedures and assessments.

1. No proof of having tested positive for COVID-19 infection at any time.
2. Presence of an active ocular/systemic disease that in the opinion of the Investigator existed prior to COVID-19 infection and is not likely a LC related condition.
3. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
4. History of laser therapy in the macular region.
5. Any ocular or systemic condition that in the opinion of the Investigator is not LC related (e.g., pre-existing cataract) that may require surgery or medical intervention during the study period.
6. Participation in any systemic experimental treatment or any other systemic investigational new drug within 90 days prior to the start of study treatment.
7. Any screening laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
8. Known hypersensitivity to Xiflam™ or excipients.
9. Known history of alcohol and/or drug abuse within 12 months prior to Visit 1 Screening that, in the opinion of the Investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject.

Contacts and Locations

Study Contact

Yasmin Massoudi

CONTACT

(781) 647-1431

ymassoudi@mersi.com

Tate Valerio

CONTACT

(781) 647-1431

tvalerio@mersi.com

Principal Investigator

Peter Chang, MD

PRINCIPAL_INVESTIGATOR

Massachusetts Eye Research and Surgery Institution (MERSI)

Study Locations (Sites)

Massachusetts Eye Research and Surgery Institution (MERSI)

Waltham, Massachusetts, 02451

United States

Collaborators and Investigators

Sponsor: Inflammx Therapeutics Inc

Peter Chang, MD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye Research and Surgery Institution (MERSI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-12

Study Completion Date2025-06

Study Record Updates

Study Start Date2024-03-12

Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

Long COVID