Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
Primary Purpose
SARS-CoV-2, Hypoxia, ARDS
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dapsone 100 MG
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2
Eligibility Criteria
Inclusion Criteria:
1. All, PCR confirmed cases of COVID-19
Exclusion Criteria:
1. Only consenting consenting patients
-
Sites / Locations
- Hunt Regional Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention
Arm Description
Outcomes
Primary Outcome Measures
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
1. Decrease in overall mortality between groups treated with standardized recommended composite therapy for COVID-19 versus group of Standardized therapy plus addition of dapson and cimedatine
Secondary Outcome Measures
Full Information
NCT ID
NCT04918914
First Posted
May 27, 2021
Last Updated
June 7, 2021
Sponsor
Hunt Regional Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04918914
Brief Title
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
Official Title
Off Label Use of Dapsone in SARS-CoV-2 Hospitalized Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 18, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunt Regional Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Abstract Background: Clinicians in pulmonary critical care medicine and critical care medicine considered dapsone administration to treat SARS-CoV-2 inflammasome. Dapsone is useful in the molecular regulation of Nod-like receptor family pyrin domain-containing 3 (NLRP3).
Objective: To study the targeting of NLRP3 itself or up-/downstream factors of the NLRP3 inflammasome by dapsone must be responsible for its observed preventive effects, functioning as a competitor.
Methods:
Patients who were on standard COVID-19 therapy are also after obtaining off label uses and explanation of side effects are started on dapsone 100-200 mg daily along with Cimetadine 400 mg three times daily.
Detailed Description
We are investigating in prospective ongoing non-randomized case study effects of addition of dapsone 100-200 mg daily in addition to standardized recommended treatment versus a a cohort of patient admitted at our institution since October 2020 versus a group that only received standardized treatment. Our primary out comes are decrease in FIO2 requirement leading to discharge from hospital and decrease in over all mortality between group treated with only standardized recommended treat versus group with addition of dapsone and cimetadine.
An objective criteria of improvement, was used for effectiveness of therapy.
A. a reduction in the FIO2 requirement and
B. a decrease in the progression of hypoxia. We treated the patients with standard COVID-19 ARDS treatment with dapsone 100 mg to target NLRP3 inflammasomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2, Hypoxia, ARDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Addition of dapsone to COVID19 patient treated with standard treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Dapsone 100 MG
Intervention Description
Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID
Primary Outcome Measure Information:
Title
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
Description
1. Decrease in overall mortality between groups treated with standardized recommended composite therapy for COVID-19 versus group of Standardized therapy plus addition of dapson and cimedatine
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. All, PCR confirmed cases of COVID-19
Exclusion Criteria:
1. Only consenting consenting patients
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kanwar
Phone
4694228931
Email
bkanwar2@yahoo.com
Facility Information:
Facility Name
Hunt Regional Medical Center
City
Greenville
State/Province
Texas
ZIP/Postal Code
75401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Badar Kanwar
Phone
469-422-8931
Email
BKANWAR2@YAHOO.COM
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment
We'll reach out to this number within 24 hrs