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

Hypoxia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04918914
• Other study ID #: Badar Kanwar
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 18, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: Hunt Regional Medical Center
• Contact: Kanwar
• Phone: 4694228931
• Email: bkanwar2[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. All, PCR confirmed cases of COVID-19

Exclusion Criteria:

1. Only consenting consenting patients

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Related Conditions & MeSH terms

• ARDS
• Hypoxia
• SARS-CoV-2

Intervention

Drug:
• Dapsone 100 MG
Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID

Locations

Country	Name	City	State
United States	Hunt Regional Medical Center	Greenville	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Hunt Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year