Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment

Sponsor

Hunt Regional Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04918914

Collaborator

(none)

100

Enrollment

Location

Arm

14.4

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Hypoxia ARDS	Drug: Dapsone 100 MG	Early Phase 1

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 reduction in the FIO2 requirement and
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Addition of dapsone to COVID19 patient treated with standard treatmentAddition of dapsone to COVID19 patient treated with standard treatment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Off Label Use of Dapsone in SARS-CoV-2 Hospitalized Patients

Actual Study Start Date :

Oct 18, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention	Drug: Dapsone 100 MG Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID

Arm

Intervention/Treatment

Other: Intervention

Drug: Dapsone 100 MG

Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID

Outcome Measures

Primary Outcome Measures

Critical Care Results of SARS-CoV-2 ARDS by Dapsone and Standard COVID-19 Treatment [1 year]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All, PCR confirmed cases of COVID-19

Exclusion Criteria:

Only consenting consenting patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hunt Regional Medical Center	Greenville	Texas	United States	75401

Sponsors and Collaborators

Hunt Regional Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Badar Kanwar, Principal Investigator, Hunt Regional Medical Center

ClinicalTrials.gov Identifier:

NCT04918914

Other Study ID Numbers:

Badar Kanwar

First Posted:

Jun 9, 2021

Last Update Posted:

Jun 9, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypoxia

Dapsone

Study Results

No Results Posted as of Jun 9, 2021