SARS-CoV-2 CTLS for Mild to Moderate COVID-19 Disease

Phase 1

Recruiting

• Conditions: Covid19
• Interventions: Other: Standard of Care; Biological: SARS-CoV2-CTLS

• Registration Number: NCT04896606
• Lead Sponsor: New York Medical College

Brief Summary

The 2019 Severe Acute Respiratory Syndrome (SARS) is a global pandemic secondary to a novel coronavirus - SARS-CoV-2. The reported case-fatality ratio for SARS-CoV-2 in the United States is 1.8% with a current death toll of \>300,000 and climbing.4 There is no accepted standard of care or FDA approved therapies for treatment of COVID-19. Virus specific cytotoxic T lymphocytes (CTLs) have become an important part of the treatment landscape for viral reactivation post hematopoietic and solid organ transplantation. Donor derived CTLs have been shown to be safe and effective against a variety of viruses including CMV, EBV, BK and adenovirus. We hypothesize that SARS-CoV-2 specific CTLs generated from a previously infected family donor will be safe and effective for treatment of COVID-19 in family members with mild to moderate disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-19
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-21
• Study Start: 2021-09-20
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care Only	Standard of Care	Patients will NOT received COVID CTLs but will get standard of care.
SARS-CoV-2 CTLS + Standard of Care	Standard of Care	Patients will get family donor derived SARS-CoV-2 cytotoxic t-lymphocytes up to 5 times every 2 weeks along with Standard of care of COVID-19.
SARS-CoV-2 CTLS + Standard of Care	SARS-CoV2-CTLS	Patients will get family donor derived SARS-CoV-2 cytotoxic t-lymphocytes up to 5 times every 2 weeks along with Standard of care of COVID-19.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	12 weeks	no adverse events will occur due to CTL infusion(s)

Trial Locations

Locations (4)

New York Medical College; 🇺🇸 Valhalla, New York, United States

Nationwide Children's Hosptial; 🇺🇸 Columbus, Ohio, United States

Children's Hospital of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Medical College of Wisconsin/Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States